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The enrollment was not achieved within proposed timeframe.
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The study will enroll 5 individuals post-stroke to examine the feasibility and efficacy of a high frequency repetitive transcranial magnetic stimulation (rTMS) combined with body weight supported treadmill training.
The purpose of this pilot study is to examine the feasibility and efficacy of 5Hz repetitive transcranial magnetic stimulation (rTMS) applied to bilateral motor areas as an adjuvant intervention to task-specific body weight supported treadmill training (BWSTT) in individuals with subacute stroke.
Five individuals with a diagnosis of subacute stroke will be recruited and assigned to either high frequency or sham rTMS group.Both groups will receive a comprehensive assessment of their motor function, gait performance and neurophysiological function before the training. Both groups will then go through a 10 week (24 sessions) of gait training with body weight supported treadmill. For the high frequency rTMS group, they will receive 5 Hz rTMS applied to bilateral motor areas prior to each gait training session. For the sham rTMS group, they will receive a sham stimulation prior to the gait training sessions. All participants will receive another comprehensive assessment after the training concludes. The assessor will be blinded to the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Frequency rTMS | Experimental | The High Frequency rTMS group will receive real repetitive transcranial magnetic stimulation (rTMS) in 5Hz at 90% of resting motor threshold delivered to the bilateral motor areas via a figure of 8 air-filmed coil. The stimulation is structured as 24 10-second trains with a inter-train interval of 30 second. |
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| Sham rTMS | Sham Comparator | The Sham rTMS group will receive the same protocol but delivered via a sham coil which generates the same auditory and cutaneous feedback as the real stimulation. However, there will be no active stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Frequency rTMS | Device | Participants in the intervention group will receive 1200 stimuli at the intensity of 90% of resting motor threshold via an air-filmed coil placed on the vertex. The stimulation will be delivered across 24 sessions (in 10 weeks). Right after each session, participants will receive a 45-minute structured body weight supported treadmill training. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Walking Speed | Participant's regular and fast walking speeds (in m/s) will be measured using GaitRite. A faster walking speed indicates a better gait performance. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | Quality of life will be measure using Stroke Impact Scale (SIS). The SIS is a paper and pencil questionnaire consisting 59 items grouped into 8 domains. Each item is rated on a 5-point Likert scale; a higher item score indicates a lower level of difficulty experienced with the item. Item scores are averaged and transformed into domain scores ranging from 0 to 100. A higher domain score indicates a lower level of difficulty. The SIS is well-validated in stroke. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | High Frequency rTMS | The High Frequency rTMS group will receive real repetitive transcranial magnetic stimulation (rTMS) in 5Hz at 90% of resting motor threshold delivered to the bilateral motor areas via a figure of 8 air-filmed coil. The stimulation is structured as 24 10-second trains with a inter-train interval of 30 second. High Frequency rTMS: Participants in the intervention group will receive 1200 stimuli at the intensity of 90% of resting motor threshold via an air-filmed coil placed on the vertex. The stimulation will be delivered across 24 sessions (in 10 weeks). Right after each session, participants will receive a 45-minute structured body weight supported treadmill training. |
| FG001 | Sham rTMS | The Sham rTMS group will receive the same protocol but delivered via a sham coil which generates the same auditory and cutaneous feedback as the real stimulation. However, there will be no active stimulation. Sham rTMS: Participants in the sham group will receive the same duration of stimulation via a sham coil placed on the vertex.Right after each session, participants will receive a 45-minute structured body weight supported treadmill training. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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No participants were enrolled for the Sham rTMS group
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| ID | Title | Description |
|---|---|---|
| BG000 | High Frequency rTMS | The High Frequency rTMS group will receive real repetitive transcranial magnetic stimulation (rTMS) in 5Hz at 90% of resting motor threshold delivered to the bilateral motor areas via a figure of 8 air-filmed coil. The stimulation is structured as 24 10-second trains with a inter-train interval of 30 second. High Frequency rTMS: Participants in the intervention group will receive 1200 stimuli at the intensity of 90% of resting motor threshold via an air-filmed coil placed on the vertex. The stimulation will be delivered across 24 sessions (in 10 weeks). Right after each session, participants will receive a 45-minute structured body weight supported treadmill training. |
| 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 Walking Speed | Participant's regular and fast walking speeds (in m/s) will be measured using GaitRite. A faster walking speed indicates a better gait performance. | We only enrolled 1 participant and the participant did not finish the protocol. We only collected baseline data but not post-training data. The changes in outcome could not be calculated. | Posted | 10 weeks |
|
2 weeks The only enrolled participant started on November 12 2018 and withdrew on November 26 2018. Participant was monitored via emails and texts up to 2 weeks after the last session (Nov 26 2018)
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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 | The High Frequency rTMS group will receive real repetitive transcranial magnetic stimulation (rTMS) in 5Hz at 90% of resting motor threshold delivered to the bilateral motor areas via a figure of 8 air-filmed coil. The stimulation is structured as 24 10-second trains with a inter-train interval of 30 second. High Frequency rTMS: Participants in the intervention group will receive 1200 stimuli at the intensity of 90% of resting motor threshold via an air-filmed coil placed on the vertex. The stimulation will be delivered across 24 sessions (in 10 weeks). Right after each session, participants will receive a 45-minute structured body weight supported treadmill training. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hui-Ting Goh, Assistant Professor | 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 | Jan 4, 2021 | May 3, 2023 | Prot_SAP_004.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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|
| Sham rTMS | Device | Participants in the sham group will receive the same duration of stimulation via a sham coil placed on the vertex.Right after each session, participants will receive a 45-minute structured body weight supported treadmill training. |
|
| 10 weeks |
| Change in Motor Function | Motor function will be quantified using Fugl-Meyer Motor Assessment. The Fugl-Meyer Assessment is well-validated in stroke and has a total score ranging from 0 to 100. A higher total score suggests a better level of motor function. | 10 weeks |
| Change in Cortical Excitability | Cortical excitability will be measured using single pulse transcranial magnetic stimulation. Excitability will be quantified using motor evoked potential amplitude (in mV). A higher motor evoked potential amplitude indicates a greater level of excitability. | 10 weeks |
| Change in Walking Endurance | Walking endurance will be measured using Six Minute Walk Test and measured in meters. A higher score in the 6 minute walk test (in meters) indicates a better walking endurance. | 10 weeks |
| BG001 | Sham rTMS | The Sham rTMS group will receive the same protocol but delivered via a sham coil which generates the same auditory and cutaneous feedback as the real stimulation. However, there will be no active stimulation. Sham rTMS: Participants in the sham group will receive the same duration of stimulation via a sham coil placed on the vertex.Right after each session, participants will receive a 45-minute structured body weight supported treadmill training. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sham rTMS | The Sham rTMS group will receive the same protocol but delivered via a sham coil which generates the same auditory and cutaneous feedback as the real stimulation. However, there will be no active stimulation. Sham rTMS: Participants in the sham group will receive the same duration of stimulation via a sham coil placed on the vertex.Right after each session, participants will receive a 45-minute structured body weight supported treadmill training. |
|
| Secondary | Change in Quality of Life | Quality of life will be measure using Stroke Impact Scale (SIS). The SIS is a paper and pencil questionnaire consisting 59 items grouped into 8 domains. Each item is rated on a 5-point Likert scale; a higher item score indicates a lower level of difficulty experienced with the item. Item scores are averaged and transformed into domain scores ranging from 0 to 100. A higher domain score indicates a lower level of difficulty. The SIS is well-validated in stroke. | We only enrolled 1 participant and the participant did not finish the protocol. We only collected baseline data but not post-training data. The changes in outcome could not be calculated. | Posted | 10 weeks |
|
|
| Secondary | Change in Motor Function | Motor function will be quantified using Fugl-Meyer Motor Assessment. The Fugl-Meyer Assessment is well-validated in stroke and has a total score ranging from 0 to 100. A higher total score suggests a better level of motor function. | We only enrolled 1 participant and the participant did not finish the protocol. We only collected baseline data but not post-training data. The changes in outcome could not be calculated. | Posted | 10 weeks |
|
|
| Secondary | Change in Cortical Excitability | Cortical excitability will be measured using single pulse transcranial magnetic stimulation. Excitability will be quantified using motor evoked potential amplitude (in mV). A higher motor evoked potential amplitude indicates a greater level of excitability. | We only enrolled 1 participant and the participant did not finish the protocol. We only collected baseline data but not post-training data. The changes in outcome could not be calculated. | Posted | 10 weeks |
|
|
| Secondary | Change in Walking Endurance | Walking endurance will be measured using Six Minute Walk Test and measured in meters. A higher score in the 6 minute walk test (in meters) indicates a better walking endurance. | We only enrolled 1 participant and the participant did not finish the protocol. We only collected baseline data but not post-training data. The changes in outcome could not be calculated. | Posted | 10 weeks |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Sham rTMS | The Sham rTMS group will receive the same protocol but delivered via a sham coil which generates the same auditory and cutaneous feedback as the real stimulation. However, there will be no active stimulation. Sham rTMS: Participants in the sham group will receive the same duration of stimulation via a sham coil placed on the vertex.Right after each session, participants will receive a 45-minute structured body weight supported treadmill training. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |