Trial Outcomes & Findings for rTMS Combined With BWSTT in Stroke With Body Weight Supported Treadmill Training (BWSTT) After Stroke (NCT NCT03441334)
NCT ID: NCT03441334
Last Updated: 2023-05-06
Results Overview
Participant's regular and fast walking speeds (in m/s) will be measured using GaitRite. A faster walking speed indicates a better gait performance.
TERMINATED
NA
1 participants
10 weeks
2023-05-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
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Overall Study
STARTED
|
1
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0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
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Baseline Characteristics
rTMS Combined With BWSTT in Stroke With Body Weight Supported Treadmill Training (BWSTT) After Stroke
Baseline characteristics by cohort
| Measure |
High Frequency rTMS
n=1 Participants
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.
|
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.
|
Total
n=1 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
58 years
STANDARD_DEVIATION 0 • n=93 Participants
|
—
|
58 years
STANDARD_DEVIATION 0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=93 Participants
|
—
|
1 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: 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.
Participant's regular and fast walking speeds (in m/s) will be measured using GaitRite. A faster walking speed indicates a better gait performance.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
High Frequency rTMS
Sham rTMS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Hui-Ting Goh, Assistant Professor
Texas Woman's University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place