AphasiaPARTNCT01512264
Post-Stroke Aphasia and Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment Study
A study testing Magstim SuperRapid in people with Aphasia and Stroke, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Magstim SuperRapid
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 20 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Post-Stroke Aphasia and rTMS Treatment Study (PART)
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.
Read the 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.
- Being tested
- Magstim SuperRapid
- Keywords
- Aphasia, Stroke, functional Magnetic resonance imaging, fMRI, Language recovery after stroke, constraint induced aphasia therapy, CIAT, Repetitive transcranial magnetic stimulation, rTMS
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magstim SuperRapidDevice
Also called Repetitive Transcranial Magnetic Stimulation, rTMS
This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Experimental | 3 weeks of nerTMS Receives: Device: Magstim SuperRapid |
| 1 week of Sham Treatment + 2 weeks of nerTMS | Sham comparator | 1 week of Sham Treatment + 2 weeks of nerTMS Receives: Device: Magstim SuperRapid |
| 2 weeks of Sham Treatment +1 week of nerTMS | Sham comparator | 2 weeks of Sham Treatment +1 week of nerTMS Receives: Device: Magstim SuperRapid |
| Control Group | Placebo comparator | 3 weeks of Sham Treatment Receives: Device: Magstim SuperRapid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline
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.
Measured: Baseline: 1 week before the first nerTMS treatment
Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up
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.
Measured: within 1 week post treatment
Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up
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.
Measured: 3 months post treatment
Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline
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.
Measured: 1 week before the first nerTMS treatment
Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up
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.
Measured: within 1 week post treatment
Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up
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.
Measured: 3 months post treatment
Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline
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.
Measured: 1 week before the first nerTMS treatment
Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up
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.
Measured: within 1 week post treatment
Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up
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.
Measured: 3 months post treatment
Western Aphasia Battery (WAB) - Baseline
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.
Measured: Baseline: 1 week before the first nerTMS treatment
Western Aphasia Battery (WAB) - Immediate Follow-Up
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.
Measured: within 1 week post treatment
Western Aphasia Battery (WAB) - Long-Term Follow-Up
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.
Measured: 3 months post treatment
Secondary outcomes (9)
Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline
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).
Measured: Baseline: 1 week before the first nerTMS treatment
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up
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).
Measured: within 1 week post treatment
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up
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).
Measured: 3 months post treatment
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline
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).
Measured: Baseline: 1 week before the first nerTMS treatment
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up
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).
Measured: within 1 week post treatment
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Long-term Follow Up
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).
Measured: 3 months post treatment
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Baseline
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).
Measured: Baseline: 1 week before the first nerTMS treatment
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up
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).
Measured: within 1 week post treatment
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Long-term Follow Up
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).
Measured: 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJan 2012
- Primary completion20 Jul 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Jerzy P Szaflarski, University of Alabama at Birmingham
- Investigators
- Jerzy P Szaflarski, MD, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512264
- Sponsor's protocol ID
- R01HD068488
- Acronym
- PART
- Status last verified
- Jul 2020
- First submitted
- 10 Jan 2012
- Last updated
- 14 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Stroke Aphasia and rTMS Treatment Study (PART)
- ClinicalTrials.gov ID
- NCT01512264
- Acronym / sponsor ID
- PART / R01HD068488
- Keywords
- Aphasia, Stroke, functional Magnetic resonance imaging, fMRI, Language recovery after stroke, constraint induced aphasia therapy, CIAT, Repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Jan 2012
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Posted 16 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rTMS | Experimental | Device: Magstim SuperRapid3 weeks of nerTMS |
| 1 week of Sham Treatment + 2 weeks of nerTMS | Sham comparator | Device: Magstim SuperRapid1 week of Sham Treatment + 2 weeks of nerTMS |
| 2 weeks of Sham Treatment +1 week of nerTMS | Sham comparator | Device: Magstim SuperRapid2 weeks of Sham Treatment +1 week of nerTMS |
| Control Group | Placebo comparator | Device: Magstim SuperRapid3 weeks of Sham Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magstim SuperRapidAlso: Repetitive Transcranial Magnetic Stimulation, rTMSThis design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery. | Device | 1 week of Sham Treatment + 2 weeks of nerTMS, 2 weeks of Sham Treatment +1 week of nerTMS, Control Group, rTMS |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
9 secondary outcomes
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
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up
Time frame: within 1 week post treatment
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up
Time frame: 3 months post treatment
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
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
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
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
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up
Time frame: within 1 week post treatment
Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Long-term Follow Up
Time frame: 3 months post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerzy P Szaflarski, MD, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magstim SuperRapid in people with Aphasia and Stroke, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline (time frame: Baseline: 1 week before the first nerTMS treatment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.