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Post-Stroke Aphasia and Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment Study (PART)

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ClinicalTrials.gov Identifier: NCT01512264
Recruitment Status : Completed
First Posted : January 19, 2012
Results First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Jerzy P Szaflarski, University of Alabama at Birmingham

Brief Summary:
In this study the investigators will examine the efficacy of navigated excitatory repetitive transcranial magnetic stimulation (nerTMS) for the treatment of post stroke aphasia. The investigators expect that this new types of rehabilitation (nerTMS) will help patients with aphasia return to their lives as they were prior to the stroke.

Condition or disease Intervention/treatment Phase
Aphasia Stroke Device: Magstim SuperRapid Not Applicable

Detailed Description:

Aphasia after stroke is associated with high mortality, significant motor impairment, and severe limitations in social participation. During the past decade, therapies administered by stroke teams have made great strides to limit the motor impairments caused by stroke. Unfortunately, progress in aphasia rehabilitation has not experienced the same rapid advancement. This proposal is based on preliminary evidence from our recently completed pilot study which showed that navigated excitatory repetitive transcranial magnetic stimulation (nerTMS) targeted to residual activity in the affected hemisphere has a significant beneficial effect on post-stroke aphasia recovery.1 The main aim of this study is to conduct a double-blind, sham-controlled, dose-response nerTMS treatment trial in subjects with chronic aphasia. By conducting this comparative trial, we will provide clinical (qualitative and quantitative) and imaging evidence that nerTMS improves language function after stroke when compared to standard treatment (ST). The findings will have implications for patients with post-stroke aphasia in that once the study is completed and the results are available, rehabilitation specialists may be able to change their practice pattern by offering an additional tool to aid patients in recovering their language skills with improved participation in society and enhanced quality of life.

To fill the gap in our therapeutic arsenal for aphasia, we propose a study with the following specific aims: (1) to determine the comparative efficacy and optimal dosing of nerTMS on aphasia recovery using a randomized, double-blind, sham-controlled study design. Subjects (15/group) will be randomly assigned to 4 treatment groups: (a) 3 weeks of nerTMS, (b) 1 week of ST + 2 weeks of nerTMS, (c) 2 weeks of ST +1 week of nerTMS, or (d) 3 weeks of ST (control group). This design will allow systematic evaluation of the efficacy of nerTMS and will determine its most optimal dose for language recovery. Short- and long-term outcomes will be evaluated with aphasia testing (AT) and fMRI; (2) to use fMRI to assess changes in language lateralization in response to nerTMS. We will examine the relationship between the degree of pre-nerTMS language lateralization (fMRI) with the post-nerTMS language outcomes (AT) and determine whether fMRI language lateralization can predict AT performance following nerTMS targeted to the left middle cerebral artery (LMCA) stroke areas.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-Stroke Aphasia and rTMS Treatment Study (PART)
Study Start Date : January 2012
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : July 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: rTMS
3 weeks of nerTMS
Device: Magstim SuperRapid
This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
Other Name: Repetitive Transcranial Magnetic Stimulation, rTMS

Sham Comparator: 1 week of Sham Treatment + 2 weeks of nerTMS
1 week of Sham Treatment + 2 weeks of nerTMS
Device: Magstim SuperRapid
This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
Other Name: Repetitive Transcranial Magnetic Stimulation, rTMS

Sham Comparator: 2 weeks of Sham Treatment +1 week of nerTMS
2 weeks of Sham Treatment +1 week of nerTMS
Device: Magstim SuperRapid
This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
Other Name: Repetitive Transcranial Magnetic Stimulation, rTMS

Placebo Comparator: Control Group
3 weeks of Sham Treatment
Device: Magstim SuperRapid
This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
Other Name: Repetitive Transcranial Magnetic Stimulation, rTMS




Primary Outcome Measures :
  1. Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline [ Time Frame: Baseline: 1 week before the first nerTMS treatment ]
    60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.

  2. Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up [ Time Frame: within 1 week post treatment ]
    60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.

  3. Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up [ Time Frame: 3 months post treatment ]
    60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.

  4. Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline [ Time Frame: 1 week before the first nerTMS treatment ]
    The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. "Animals", "Fruits") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.

  5. Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up [ Time Frame: within 1 week post treatment ]
    The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. "Animals", "Fruits") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.

  6. Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up [ Time Frame: 3 months post treatment ]
    The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. "Animals", "Fruits") and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.

  7. Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline [ Time Frame: 1 week before the first nerTMS treatment ]
    The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. "C", "F", "L") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.

  8. Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up [ Time Frame: within 1 week post treatment ]
    The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. "C", "F", "L") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.

  9. Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up [ Time Frame: 3 months post treatment ]
    The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. "C", "F", "L") and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia.

  10. Western Aphasia Battery (WAB) - Baseline [ Time Frame: Baseline: 1 week before the first nerTMS treatment ]
    WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.

  11. Western Aphasia Battery (WAB) - Immediate Follow-Up [ Time Frame: within 1 week post treatment ]
    WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.

  12. Western Aphasia Battery (WAB) - Long-Term Follow-Up [ Time Frame: 3 months post treatment ]
    WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.


Secondary Outcome Measures :
  1. Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline [ Time Frame: Baseline: 1 week before the first nerTMS treatment ]
    Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).

  2. Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up [ Time Frame: within 1 week post treatment ]
    Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).

  3. Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up [ Time Frame: 3 months post treatment ]
    Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).

  4. Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline [ Time Frame: Baseline: 1 week before the first nerTMS treatment ]
    Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).

  5. Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up [ Time Frame: within 1 week post treatment ]
    Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).

  6. Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Long-term Follow Up [ Time Frame: 3 months post treatment ]
    Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).

  7. Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Baseline [ Time Frame: Baseline: 1 week before the first nerTMS treatment ]
    Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).

  8. Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up [ Time Frame: within 1 week post treatment ]
    Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).

  9. Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Long-term Follow Up [ Time Frame: 3 months post treatment ]
    Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from "-1" (or -100%) indicating left-hemispheric lateralization to "1" (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • LMCA stroke as indicated by the presence of aphasia and MRI lesion in the LMCA distribution
  • Moderate aphasia (Token Test score between 40th and 90th percentile)
  • Fluency in English
  • Provision of written informed consent by the patient and/or the next of kin

Exclusion Criteria:

  • Age less than 18 years
  • Underlying degenerative or metabolic disorder or supervening medical illness
  • Severe depression or other psychiatric disorder
  • Positive pregnancy test in women of childbearing age
  • Any contraindication to MRI/fMRI at 3T (i.e., intracranial metal implants, claustrophobia)
  • Any contraindication to nerTMS (e.g., seizures or epilepsy)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512264


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Jerzy P Szaflarski, MD, PhD University of Alabama at Birmingham
  Study Documents (Full-Text)

Documents provided by Jerzy P Szaflarski, University of Alabama at Birmingham:

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Responsible Party: Jerzy P Szaflarski, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01512264     History of Changes
Other Study ID Numbers: R01HD068488 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2012    Key Record Dates
Results First Posted: August 16, 2019
Last Update Posted: August 16, 2019
Last Verified: July 2019
Keywords provided by Jerzy P Szaflarski, University of Alabama at Birmingham:
Aphasia
Stroke
functional Magnetic resonance imaging
fMRI
Language recovery after stroke
constraint induced aphasia therapy
CIAT
Repetitive transcranial magnetic stimulation
rTMS
Additional relevant MeSH terms:
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Stroke
Aphasia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms