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The study aims to identify neural locus critical for dual-task walking (walking and talking) in individuals with stroke. To achieve this aim, the investigators apply repetitive transcranial magnetic stimulation (rTMS) to different parts of the brain and evaluate the effects of brain stimulation on dual-task walking speed.
This study will enroll 12 individuals with a stroke at least 6 months ago. Participants will be tested across 3 sessions and each session will be approximately 1 week apart from each other. During testing, participants will be asked to walk under two conditions: single- and dual-task conditions. Under the single-task condition, participants walk on a instrumented mat such that their gait performance will be captured. Under the dual-task condition, participants walk on the mat while performing a counting backward task. The walking assessment is followed by a 12 minute non-invasive brain stimulation using high frequency rTMS. Another walking assessment will be conducted right after the brain stimulation session. High frequency rTMS will be applied to different neural loci, namely primary motor cortex (M1), supplementary motor area (SMA), and dorsolateral prefrontal cortex (DLPFC). The walking speed under two different conditions will be compared before and after brain stimulation to different neural loci.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High frequency rTMS | Experimental | High frequency rTMS will be applied to different neural loci based on the randomized sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high frequency rTMS | Device | Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex (M1), supplementary motor area (SMA) and dorsolateral prefrontal cortex (DLPFC) at different sessions. Walking performance is evaluated before and after the brain stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gait Speed | gait speed in m/s will be captured using GaitRite gait assessment walkway | before and 10 minutes after the non-invasive brain stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Step Lengths | Step lengths in centimeter (cm) will be captured using GaitRite gait assessment walkway | before and 10 minutes after the non-invasive brain stimulation |
| Change in Single Support Times |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui-Ting Goh | Texas Woman's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Woman's University | Dallas | Texas | 75235 | United States |
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Participants were recruited from Dallas Fort Worth metro area. Recruitment started in October 2016 and last participant was enrolled in Oct 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) | High frequency rTMS will be applied to different neural loci based on the randomized sessions. high frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Frequency rTMS | High frequency rTMS will be applied to different neural loci based on the randomized sessions. high frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Gait Speed | gait speed in m/s will be captured using GaitRite gait assessment walkway | Changes in gait speed under the dual-task conditions were compared across the 3 visits. | Posted | Mean | Standard Error | m/s | before and 10 minutes after the non-invasive brain stimulation |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Frequency rTMS | High frequency rTMS will be applied to different neural loci based on the randomized sessions. high frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment | 1 participant reported mild headache after stimulation. The headache was resolved about 2 hours after the session ended. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hui-Ting Goh | Texas Woman's University | 2146897723 | HGoh1@twu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2016 | Oct 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
Single support times (in % of gait cycle) will be captured using GaitRite gait assessment walkway
| before and 10 minutes after the non-invasive brain stimulation |
| Change in Counting Task Performance | number of correct responses in counting backward task | before and 10 minutes after the non-invasive brain stimulation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Step Lengths | Step lengths in centimeter (cm) will be captured using GaitRite gait assessment walkway | Changes in right (R) and left (L) step lengths after repetitive transcranial magnetic stimulation (rTMS) applied to dorsolateral prefrontal cortex (DLPFC) | Posted | Mean | Standard Error | centimeter (cm) | before and 10 minutes after the non-invasive brain stimulation |
|
|
|
| Secondary | Change in Single Support Times | Single support times (in % of gait cycle) will be captured using GaitRite gait assessment walkway | Changes in right (R) and left (L) single support time after repetitive transcranial magnetic stimulation (rTMS) applied to dorsolateral prefrontal cortex (DLPFC) | Posted | Mean | Standard Error | percentage of gait cycle | before and 10 minutes after the non-invasive brain stimulation |
|
|
|
| Secondary | Change in Counting Task Performance | number of correct responses in counting backward task | number of correct response under the dual-task conditions before and after the rTMS | Posted | Mean | Standard Error | number of correct responses | before and 10 minutes after the non-invasive brain stimulation |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 2 |
| 15 |
|
| Infection | Infections and infestations | Non-systematic Assessment | 1 participant was admitted to the hospital between the1st and the 2nd visit due to a lung infection. The event was deemed unrelated to the study. |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
|