A Phase II, Randomized Blinded Study of the Effects of Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for the ... View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2019-2023

ABSTRACT

Transcranial Magnetic Stimulation (TMS) has been demonstrated to improve language function in subjects with chronic aphasia in a number of small studies, many of which did not include a control group. Although the treatment appears promising, data to date do not permit an adequate assessment of the utility of the technique. The investigators propose to study the effects of TMS combined with Constraint Induced Language Therapy (CILT) in 75 subjects with chronic aphasia. Subjects will be randomized in a 2:1 ratio to TMS with CILT or sham TMS with CILT. One Hz TMS at 90% motor threshold will be delivered to the right inferior frontal gyrus for 20 minutes in 10 sessions over 2 weeks; language therapy will be provided for one hour immediately after the conclusion of each session of TMS. Change from baseline in the Western Aphasia Battery Aphasia Quotient at 6 months after the end of TMS treatment will serve as the primary outcome measure. A secondary aim is to identify anatomic and behavioral predictors of response to treatment. Finally, a third aim is to identify the mechanism underlying the beneficial effect of the treatment using a variety of imaging techniques. Subjects who have no contraindication to the MRI will undergo fMRI imaging prior to and at 6 months after therapy. Using modern network analyses and robust machine learning techniques, the investigators will identify changes in the strengths of connections between nodes in the language network to address specific hypotheses regarding the effects of TMS and CILT on brain organization that are associated with beneficial response to treatment. Detailed Description TMS is a technique by which a brief electrical current is induced in brain tissue causing a brief suppression of the excitability of the underlying tissue; the technique, which was introduced in the 1980s and has been extensively used around the world, has been shown to transiently improve or disrupt specific cognitive operations. To achieve this end, a coil is positioned against the subject's head. The delivery of a single pulse begins with the discharge of current from a capacitor into a circular or figure-of-eight coil; this electrical current generates a brief magnetic field of up to 2.2 Tesla. As the pulse of electricity has a rise time of 0.2 ms. and a duration of 1 ms., the magnetic field changes in intensity quite rapidly. Because the magnetic field passes freely through the scalp, skull, and meninges, the flux in the magnetic field induces a small electric field in the brain that transiently alters neural activity. TMS may be delivered in a variety of ways. The investigators propose to use 1 Hz TMS; that is, TMS pulses will be delivered at a frequency of 1/second. This style of TMS is assumed to be inhibitory in that it transiently suppresses the function of the cortex under the coil. Using the figure-of-eight coil to be employed here, TMS is thought to reduce activity in approximately 1 cubic cm. of cortex. Many investigators have employed TMS with a frequency of 1 Hz for periods of 20 minutes and longer; mild behavioral deficits are often present for several minutes in these studies. The baseline phase will consist of 3 sessions, each lasting 1-2 hours depending on the stamina of the subject. The point of the baseline testing is to characterize the subject's language function. To that end, a number of standard language and neuropsychological tasks will be administered. These include the Western Aphasia Battery, Pyramids and Palm Trees test, Figural Fluency Test, word and non-word repetition tasks, the Nicholas and Brookshire Narratives, CILT stimulus naming, and Northwestern Assessment of Verbs and Sentences. Additionally, during the baseline, subjects will undergo MRI of the brain or, if they have a contraindication to MRI, a CAT scan of the head. No contrast will be used. In the treatment phase, there will be 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz TMS at 90% motor threshold will be delivered to the inferior pars triangularis. Each TMS treatment session will be immediately followed by a 60-90 minute session of CILT There will be two 3-month post-treatment visits and two 6-month post-treatment visits in which the full battery of language and cognitive assessments will be repeated. Subjects who are able to undergo MRI scanning will have anatomic and fMRI scans at the first 6-month post-treatment visit. The investigators will pair TMS with CILT which has been shown to have positive outcomes in post-stroke aphasia. CILT invokes use-dependent learning in communicative interactions by requiring spoken output and restricting use of alternative forms of communication, such as gestures. The investigators will use a dual card-matching task modeled after Maher et al. As in the original CILT design, the participant interacts verbally with a conversational partner (here, the speech language pathologist), in turn requesting a card of given description and complying with the partner's request. In this way, the treatment targets both production and comprehension. Moreover, as verbal targets increase in linguistic complexity across the protocol ("a ball", "throw a ball"; "Do you have a ball"?), a variety of lexical and phrasal structures are targeted. Studies of CILT have reported gains on multiple language behaviors, supporting its broad engagement of the language network. More... »

URL

https://clinicaltrials.gov/show/NCT03651700

Related SciGraph Publications

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/3120", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/3053", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "type": "DefinedTerm"
      }
    ], 
    "description": "Transcranial Magnetic Stimulation (TMS) has been demonstrated to improve language function in subjects with chronic aphasia in a number of small studies, many of which did not include a control group. Although the treatment appears promising, data to date do not permit an adequate assessment of the utility of the technique. The investigators propose to study the effects of TMS combined with Constraint Induced Language Therapy (CILT) in 75 subjects with chronic aphasia. Subjects will be randomized in a 2:1 ratio to TMS with CILT or sham TMS with CILT. One Hz TMS at 90% motor threshold will be delivered to the right inferior frontal gyrus for 20 minutes in 10 sessions over 2 weeks; language therapy will be provided for one hour immediately after the conclusion of each session of TMS. Change from baseline in the Western Aphasia Battery Aphasia Quotient at 6 months after the end of TMS treatment will serve as the primary outcome measure. A secondary aim is to identify anatomic and behavioral predictors of response to treatment. Finally, a third aim is to identify the mechanism underlying the beneficial effect of the treatment using a variety of imaging techniques. Subjects who have no contraindication to the MRI will undergo fMRI imaging prior to and at 6 months after therapy. Using modern network analyses and robust machine learning techniques, the investigators will identify changes in the strengths of connections between nodes in the language network to address specific hypotheses regarding the effects of TMS and CILT on brain organization that are associated with beneficial response to treatment.\n\nDetailed Description\nTMS is a technique by which a brief electrical current is induced in brain tissue causing a brief suppression of the excitability of the underlying tissue; the technique, which was introduced in the 1980s and has been extensively used around the world, has been shown to transiently improve or disrupt specific cognitive operations. To achieve this end, a coil is positioned against the subject's head. The delivery of a single pulse begins with the discharge of current from a capacitor into a circular or figure-of-eight coil; this electrical current generates a brief magnetic field of up to 2.2 Tesla. As the pulse of electricity has a rise time of 0.2 ms. and a duration of 1 ms., the magnetic field changes in intensity quite rapidly. Because the magnetic field passes freely through the scalp, skull, and meninges, the flux in the magnetic field induces a small electric field in the brain that transiently alters neural activity. TMS may be delivered in a variety of ways. The investigators propose to use 1 Hz TMS; that is, TMS pulses will be delivered at a frequency of 1/second. This style of TMS is assumed to be inhibitory in that it transiently suppresses the function of the cortex under the coil. Using the figure-of-eight coil to be employed here, TMS is thought to reduce activity in approximately 1 cubic cm. of cortex. Many investigators have employed TMS with a frequency of 1 Hz for periods of 20 minutes and longer; mild behavioral deficits are often present for several minutes in these studies. The baseline phase will consist of 3 sessions, each lasting 1-2 hours depending on the stamina of the subject. The point of the baseline testing is to characterize the subject's language function. To that end, a number of standard language and neuropsychological tasks will be administered. These include the Western Aphasia Battery, Pyramids and Palm Trees test, Figural Fluency Test, word and non-word repetition tasks, the Nicholas and Brookshire Narratives, CILT stimulus naming, and Northwestern Assessment of Verbs and Sentences. Additionally, during the baseline, subjects will undergo MRI of the brain or, if they have a contraindication to MRI, a CAT scan of the head. No contrast will be used. In the treatment phase, there will be 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz TMS at 90% motor threshold will be delivered to the inferior pars triangularis. Each TMS treatment session will be immediately followed by a 60-90 minute session of CILT There will be two 3-month post-treatment visits and two 6-month post-treatment visits in which the full battery of language and cognitive assessments will be repeated. Subjects who are able to undergo MRI scanning will have anatomic and fMRI scans at the first 6-month post-treatment visit. The investigators will pair TMS with CILT which has been shown to have positive outcomes in post-stroke aphasia. CILT invokes use-dependent learning in communicative interactions by requiring spoken output and restricting use of alternative forms of communication, such as gestures. The investigators will use a dual card-matching task modeled after Maher et al. As in the original CILT design, the participant interacts verbally with a conversational partner (here, the speech language pathologist), in turn requesting a card of given description and complying with the partner's request. In this way, the treatment targets both production and comprehension. Moreover, as verbal targets increase in linguistic complexity across the protocol (\"a ball\", \"throw a ball\"; \"Do you have a ball\"?), a variety of lexical and phrasal structures are targeted. Studies of CILT have reported gains on multiple language behaviors, supporting its broad engagement of the language network.", 
    "endDate": "2023-06-01T00:00:00Z", 
    "id": "sg:clinicaltrial.NCT03651700", 
    "keywords": [
      "Phase II", 
      "Study of the Effect", 
      "transcranial magnetic stimulation", 
      "Language Therapy", 
      "aphasia", 
      "language function", 
      "small study", 
      "control group", 
      "date", 
      "adequate assessment", 
      "utility", 
      "technique", 
      "sham", 
      "threshold", 
      "inferior frontal gyrus", 
      "session", 
      "conclusion", 
      "baseline", 
      "quotient", 
      "primary outcome measure", 
      "secondary aim", 
      "predictor", 
      "third aim", 
      "beneficial effect", 
      "imaging technique", 
      "contraindication", 
      "MRI", 
      "fMRI imaging", 
      "therapy", 
      "network analysis", 
      "machine", 
      "connection", 
      "node", 
      "language network", 
      "specific hypothesise", 
      "brain organization", 
      "beneficial response", 
      "brain tissue", 
      "suppression", 
      "excitability", 
      "tissue", 
      "world", 
      "cognitive operation", 
      "coil", 
      "head", 
      "delivery", 
      "single pulse", 
      "discharge", 
      "capacitor", 
      "figure", 
      "magnetic field", 
      "Tesla", 
      "pulse", 
      "electricity", 
      "rise time", 
      "MS.", 
      "duration", 
      "intensity", 
      "scalp", 
      "skull", 
      "meninges", 
      "flux", 
      "electric field", 
      "brain", 
      "neural activity", 
      "frequency", 
      "style", 
      "cortex", 
      "cm", 
      "Hz", 
      "period", 
      "behavioral deficit", 
      "stamen", 
      "baseline testing", 
      "standard language", 
      "task", 
      "western", 
      "pyramid", 
      "fluency", 
      "repetition", 
      "narrative", 
      "northwestern", 
      "sentence", 
      "cat", 
      "contrast", 
      "treatment phase", 
      "par", 
      "post-treatment", 
      "battery", 
      "language", 
      "cognitive assessment", 
      "MRI scanning", 
      "Magnetic Resonance Imaging", 
      "pair", 
      "positive outcome", 
      "post stroke", 
      "use-dependent", 
      "communicative interaction", 
      "spoken", 
      "alternative form", 
      "communication", 
      "gesture", 
      "card", 
      "partner", 
      "speech-language pathologist", 
      "request", 
      "treatment target", 
      "comprehension", 
      "target", 
      "linguistics", 
      "protocol", 
      "ball", 
      "gain", 
      "multiple language", 
      "engagement"
    ], 
    "name": "A Phase II, Randomized Blinded Study of the Effects of Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for the Treatment of Chronic Aphasia", 
    "sameAs": [
      "https://app.dimensions.ai/details/clinical_trial/NCT03651700"
    ], 
    "sdDataset": "clinical_trials", 
    "sdDatePublished": "2019-03-07T15:28", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "file:///pack/app/us_ct_data_00028.json", 
    "sponsor": [
      {
        "id": "https://www.grid.ac/institutes/grid.94365.3d", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.25879.31", 
        "type": "Organization"
      }
    ], 
    "startDate": "2019-01-01T00:00:00Z", 
    "subjectOf": [
      {
        "id": "https://doi.org/10.1161/strokeaha.111.647503", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1004326836"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1159/000338773", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1009146060"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1080/13554790590944663", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1011215466"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.3109/02699052.2010.494587", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1011725357"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1177/1545968314521009", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1013308414"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1044/jshr.3602.338", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1026060013"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1044/jshd.4503.308", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1026501137"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/1743-0003-9-4", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1027045697", 
          "https://doi.org/10.1186/1743-0003-9-4"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1080/02687038.2012.710316", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1027056649"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.apmr.2011.06.040", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1028227016"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.brs.2011.03.005", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1028699572"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.3109/02699052.2011.608212", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1031982938"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1100/2012/518568", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1032039806"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1161/strokeaha.111.000574", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1035345567"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1161/strokeaha.110.597864", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1035428371"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1080/02687030802235203", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1038147651"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1017/s1355617706061029", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1040383398"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1161/01.str.32.7.1621", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1041151896"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.bandl.2004.08.004", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1041850341"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1097/wnn.0b013e3181bf2d20", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1046551202"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s11910-009-0067-9", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1048913885", 
          "https://doi.org/10.1007/s11910-009-0067-9"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.12659/msm.881446", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1049549699"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.bandl.2010.01.001", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1050575487"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.bandl.2011.07.005", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1052814483"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s12975-015-0417-7", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1052891819", 
          "https://doi.org/10.1007/s12975-015-0417-7"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s12975-015-0417-7", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1052891819", 
          "https://doi.org/10.1007/s12975-015-0417-7"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1055/s-2004-825654", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1057433595"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1212/wnl.0b013e3182436558", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1064356702"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1310/tsr2003-250", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1064989165"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.3233/nre-130915", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1078758646"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.3233/rnn-130365", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1078940962"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "type": "MedicalStudy", 
    "url": "https://clinicaltrials.gov/show/NCT03651700"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/clinicaltrial.NCT03651700'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/clinicaltrial.NCT03651700'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/clinicaltrial.NCT03651700'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/clinicaltrial.NCT03651700'


 

This table displays all metadata directly associated to this object as RDF triples.

232 TRIPLES      16 PREDICATES      162 URIs      124 LITERALS      1 BLANK NODES

Subject Predicate Object
1 sg:clinicaltrial.NCT03651700 schema:about anzsrc-for:3053
2 anzsrc-for:3120
3 schema:description Transcranial Magnetic Stimulation (TMS) has been demonstrated to improve language function in subjects with chronic aphasia in a number of small studies, many of which did not include a control group. Although the treatment appears promising, data to date do not permit an adequate assessment of the utility of the technique. The investigators propose to study the effects of TMS combined with Constraint Induced Language Therapy (CILT) in 75 subjects with chronic aphasia. Subjects will be randomized in a 2:1 ratio to TMS with CILT or sham TMS with CILT. One Hz TMS at 90% motor threshold will be delivered to the right inferior frontal gyrus for 20 minutes in 10 sessions over 2 weeks; language therapy will be provided for one hour immediately after the conclusion of each session of TMS. Change from baseline in the Western Aphasia Battery Aphasia Quotient at 6 months after the end of TMS treatment will serve as the primary outcome measure. A secondary aim is to identify anatomic and behavioral predictors of response to treatment. Finally, a third aim is to identify the mechanism underlying the beneficial effect of the treatment using a variety of imaging techniques. Subjects who have no contraindication to the MRI will undergo fMRI imaging prior to and at 6 months after therapy. Using modern network analyses and robust machine learning techniques, the investigators will identify changes in the strengths of connections between nodes in the language network to address specific hypotheses regarding the effects of TMS and CILT on brain organization that are associated with beneficial response to treatment. Detailed Description TMS is a technique by which a brief electrical current is induced in brain tissue causing a brief suppression of the excitability of the underlying tissue; the technique, which was introduced in the 1980s and has been extensively used around the world, has been shown to transiently improve or disrupt specific cognitive operations. To achieve this end, a coil is positioned against the subject's head. The delivery of a single pulse begins with the discharge of current from a capacitor into a circular or figure-of-eight coil; this electrical current generates a brief magnetic field of up to 2.2 Tesla. As the pulse of electricity has a rise time of 0.2 ms. and a duration of 1 ms., the magnetic field changes in intensity quite rapidly. Because the magnetic field passes freely through the scalp, skull, and meninges, the flux in the magnetic field induces a small electric field in the brain that transiently alters neural activity. TMS may be delivered in a variety of ways. The investigators propose to use 1 Hz TMS; that is, TMS pulses will be delivered at a frequency of 1/second. This style of TMS is assumed to be inhibitory in that it transiently suppresses the function of the cortex under the coil. Using the figure-of-eight coil to be employed here, TMS is thought to reduce activity in approximately 1 cubic cm. of cortex. Many investigators have employed TMS with a frequency of 1 Hz for periods of 20 minutes and longer; mild behavioral deficits are often present for several minutes in these studies. The baseline phase will consist of 3 sessions, each lasting 1-2 hours depending on the stamina of the subject. The point of the baseline testing is to characterize the subject's language function. To that end, a number of standard language and neuropsychological tasks will be administered. These include the Western Aphasia Battery, Pyramids and Palm Trees test, Figural Fluency Test, word and non-word repetition tasks, the Nicholas and Brookshire Narratives, CILT stimulus naming, and Northwestern Assessment of Verbs and Sentences. Additionally, during the baseline, subjects will undergo MRI of the brain or, if they have a contraindication to MRI, a CAT scan of the head. No contrast will be used. In the treatment phase, there will be 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz TMS at 90% motor threshold will be delivered to the inferior pars triangularis. Each TMS treatment session will be immediately followed by a 60-90 minute session of CILT There will be two 3-month post-treatment visits and two 6-month post-treatment visits in which the full battery of language and cognitive assessments will be repeated. Subjects who are able to undergo MRI scanning will have anatomic and fMRI scans at the first 6-month post-treatment visit. The investigators will pair TMS with CILT which has been shown to have positive outcomes in post-stroke aphasia. CILT invokes use-dependent learning in communicative interactions by requiring spoken output and restricting use of alternative forms of communication, such as gestures. The investigators will use a dual card-matching task modeled after Maher et al. As in the original CILT design, the participant interacts verbally with a conversational partner (here, the speech language pathologist), in turn requesting a card of given description and complying with the partner's request. In this way, the treatment targets both production and comprehension. Moreover, as verbal targets increase in linguistic complexity across the protocol ("a ball", "throw a ball"; "Do you have a ball"?), a variety of lexical and phrasal structures are targeted. Studies of CILT have reported gains on multiple language behaviors, supporting its broad engagement of the language network.
4 schema:endDate 2023-06-01T00:00:00Z
5 schema:keywords Hz
6 Language Therapy
7 MRI
8 MRI scanning
9 MS.
10 Magnetic Resonance Imaging
11 Phase II
12 Study of the Effect
13 Tesla
14 adequate assessment
15 alternative form
16 aphasia
17 ball
18 baseline
19 baseline testing
20 battery
21 behavioral deficit
22 beneficial effect
23 beneficial response
24 brain
25 brain organization
26 brain tissue
27 capacitor
28 card
29 cat
30 cm
31 cognitive assessment
32 cognitive operation
33 coil
34 communication
35 communicative interaction
36 comprehension
37 conclusion
38 connection
39 contraindication
40 contrast
41 control group
42 cortex
43 date
44 delivery
45 discharge
46 duration
47 electric field
48 electricity
49 engagement
50 excitability
51 fMRI imaging
52 figure
53 fluency
54 flux
55 frequency
56 gain
57 gesture
58 head
59 imaging technique
60 inferior frontal gyrus
61 intensity
62 language
63 language function
64 language network
65 linguistics
66 machine
67 magnetic field
68 meninges
69 multiple language
70 narrative
71 network analysis
72 neural activity
73 node
74 northwestern
75 pair
76 par
77 partner
78 period
79 positive outcome
80 post stroke
81 post-treatment
82 predictor
83 primary outcome measure
84 protocol
85 pulse
86 pyramid
87 quotient
88 repetition
89 request
90 rise time
91 scalp
92 secondary aim
93 sentence
94 session
95 sham
96 single pulse
97 skull
98 small study
99 specific hypothesise
100 speech-language pathologist
101 spoken
102 stamen
103 standard language
104 style
105 suppression
106 target
107 task
108 technique
109 therapy
110 third aim
111 threshold
112 tissue
113 transcranial magnetic stimulation
114 treatment phase
115 treatment target
116 use-dependent
117 utility
118 western
119 world
120 schema:name A Phase II, Randomized Blinded Study of the Effects of Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for the Treatment of Chronic Aphasia
121 schema:sameAs https://app.dimensions.ai/details/clinical_trial/NCT03651700
122 schema:sdDatePublished 2019-03-07T15:28
123 schema:sdLicense https://scigraph.springernature.com/explorer/license/
124 schema:sdPublisher Ndd50f342dd9e40929a8e88a29cc69e1a
125 schema:sponsor https://www.grid.ac/institutes/grid.25879.31
126 https://www.grid.ac/institutes/grid.94365.3d
127 schema:startDate 2019-01-01T00:00:00Z
128 schema:subjectOf sg:pub.10.1007/s11910-009-0067-9
129 sg:pub.10.1007/s12975-015-0417-7
130 sg:pub.10.1186/1743-0003-9-4
131 https://doi.org/10.1016/j.apmr.2011.06.040
132 https://doi.org/10.1016/j.bandl.2004.08.004
133 https://doi.org/10.1016/j.bandl.2010.01.001
134 https://doi.org/10.1016/j.bandl.2011.07.005
135 https://doi.org/10.1016/j.brs.2011.03.005
136 https://doi.org/10.1017/s1355617706061029
137 https://doi.org/10.1044/jshd.4503.308
138 https://doi.org/10.1044/jshr.3602.338
139 https://doi.org/10.1055/s-2004-825654
140 https://doi.org/10.1080/02687030802235203
141 https://doi.org/10.1080/02687038.2012.710316
142 https://doi.org/10.1080/13554790590944663
143 https://doi.org/10.1097/wnn.0b013e3181bf2d20
144 https://doi.org/10.1100/2012/518568
145 https://doi.org/10.1159/000338773
146 https://doi.org/10.1161/01.str.32.7.1621
147 https://doi.org/10.1161/strokeaha.110.597864
148 https://doi.org/10.1161/strokeaha.111.000574
149 https://doi.org/10.1161/strokeaha.111.647503
150 https://doi.org/10.1177/1545968314521009
151 https://doi.org/10.1212/wnl.0b013e3182436558
152 https://doi.org/10.12659/msm.881446
153 https://doi.org/10.1310/tsr2003-250
154 https://doi.org/10.3109/02699052.2010.494587
155 https://doi.org/10.3109/02699052.2011.608212
156 https://doi.org/10.3233/nre-130915
157 https://doi.org/10.3233/rnn-130365
158 schema:url https://clinicaltrials.gov/show/NCT03651700
159 sgo:license sg:explorer/license/
160 sgo:sdDataset clinical_trials
161 rdf:type schema:MedicalStudy
162 Ndd50f342dd9e40929a8e88a29cc69e1a schema:name Springer Nature - SN SciGraph project
163 rdf:type schema:Organization
164 anzsrc-for:3053 schema:inDefinedTermSet anzsrc-for:
165 rdf:type schema:DefinedTerm
166 anzsrc-for:3120 schema:inDefinedTermSet anzsrc-for:
167 rdf:type schema:DefinedTerm
168 sg:pub.10.1007/s11910-009-0067-9 schema:sameAs https://app.dimensions.ai/details/publication/pub.1048913885
169 https://doi.org/10.1007/s11910-009-0067-9
170 rdf:type schema:CreativeWork
171 sg:pub.10.1007/s12975-015-0417-7 schema:sameAs https://app.dimensions.ai/details/publication/pub.1052891819
172 https://doi.org/10.1007/s12975-015-0417-7
173 rdf:type schema:CreativeWork
174 sg:pub.10.1186/1743-0003-9-4 schema:sameAs https://app.dimensions.ai/details/publication/pub.1027045697
175 https://doi.org/10.1186/1743-0003-9-4
176 rdf:type schema:CreativeWork
177 https://doi.org/10.1016/j.apmr.2011.06.040 schema:sameAs https://app.dimensions.ai/details/publication/pub.1028227016
178 rdf:type schema:CreativeWork
179 https://doi.org/10.1016/j.bandl.2004.08.004 schema:sameAs https://app.dimensions.ai/details/publication/pub.1041850341
180 rdf:type schema:CreativeWork
181 https://doi.org/10.1016/j.bandl.2010.01.001 schema:sameAs https://app.dimensions.ai/details/publication/pub.1050575487
182 rdf:type schema:CreativeWork
183 https://doi.org/10.1016/j.bandl.2011.07.005 schema:sameAs https://app.dimensions.ai/details/publication/pub.1052814483
184 rdf:type schema:CreativeWork
185 https://doi.org/10.1016/j.brs.2011.03.005 schema:sameAs https://app.dimensions.ai/details/publication/pub.1028699572
186 rdf:type schema:CreativeWork
187 https://doi.org/10.1017/s1355617706061029 schema:sameAs https://app.dimensions.ai/details/publication/pub.1040383398
188 rdf:type schema:CreativeWork
189 https://doi.org/10.1044/jshd.4503.308 schema:sameAs https://app.dimensions.ai/details/publication/pub.1026501137
190 rdf:type schema:CreativeWork
191 https://doi.org/10.1044/jshr.3602.338 schema:sameAs https://app.dimensions.ai/details/publication/pub.1026060013
192 rdf:type schema:CreativeWork
193 https://doi.org/10.1055/s-2004-825654 schema:sameAs https://app.dimensions.ai/details/publication/pub.1057433595
194 rdf:type schema:CreativeWork
195 https://doi.org/10.1080/02687030802235203 schema:sameAs https://app.dimensions.ai/details/publication/pub.1038147651
196 rdf:type schema:CreativeWork
197 https://doi.org/10.1080/02687038.2012.710316 schema:sameAs https://app.dimensions.ai/details/publication/pub.1027056649
198 rdf:type schema:CreativeWork
199 https://doi.org/10.1080/13554790590944663 schema:sameAs https://app.dimensions.ai/details/publication/pub.1011215466
200 rdf:type schema:CreativeWork
201 https://doi.org/10.1097/wnn.0b013e3181bf2d20 schema:sameAs https://app.dimensions.ai/details/publication/pub.1046551202
202 rdf:type schema:CreativeWork
203 https://doi.org/10.1100/2012/518568 schema:sameAs https://app.dimensions.ai/details/publication/pub.1032039806
204 rdf:type schema:CreativeWork
205 https://doi.org/10.1159/000338773 schema:sameAs https://app.dimensions.ai/details/publication/pub.1009146060
206 rdf:type schema:CreativeWork
207 https://doi.org/10.1161/01.str.32.7.1621 schema:sameAs https://app.dimensions.ai/details/publication/pub.1041151896
208 rdf:type schema:CreativeWork
209 https://doi.org/10.1161/strokeaha.110.597864 schema:sameAs https://app.dimensions.ai/details/publication/pub.1035428371
210 rdf:type schema:CreativeWork
211 https://doi.org/10.1161/strokeaha.111.000574 schema:sameAs https://app.dimensions.ai/details/publication/pub.1035345567
212 rdf:type schema:CreativeWork
213 https://doi.org/10.1161/strokeaha.111.647503 schema:sameAs https://app.dimensions.ai/details/publication/pub.1004326836
214 rdf:type schema:CreativeWork
215 https://doi.org/10.1177/1545968314521009 schema:sameAs https://app.dimensions.ai/details/publication/pub.1013308414
216 rdf:type schema:CreativeWork
217 https://doi.org/10.1212/wnl.0b013e3182436558 schema:sameAs https://app.dimensions.ai/details/publication/pub.1064356702
218 rdf:type schema:CreativeWork
219 https://doi.org/10.12659/msm.881446 schema:sameAs https://app.dimensions.ai/details/publication/pub.1049549699
220 rdf:type schema:CreativeWork
221 https://doi.org/10.1310/tsr2003-250 schema:sameAs https://app.dimensions.ai/details/publication/pub.1064989165
222 rdf:type schema:CreativeWork
223 https://doi.org/10.3109/02699052.2010.494587 schema:sameAs https://app.dimensions.ai/details/publication/pub.1011725357
224 rdf:type schema:CreativeWork
225 https://doi.org/10.3109/02699052.2011.608212 schema:sameAs https://app.dimensions.ai/details/publication/pub.1031982938
226 rdf:type schema:CreativeWork
227 https://doi.org/10.3233/nre-130915 schema:sameAs https://app.dimensions.ai/details/publication/pub.1078758646
228 rdf:type schema:CreativeWork
229 https://doi.org/10.3233/rnn-130365 schema:sameAs https://app.dimensions.ai/details/publication/pub.1078940962
230 rdf:type schema:CreativeWork
231 https://www.grid.ac/institutes/grid.25879.31 schema:Organization
232 https://www.grid.ac/institutes/grid.94365.3d schema:Organization
 




Preview window. Press ESC to close (or click here)


...