Trial Outcomes & Findings for Effects of Combined rTMS and Treadmill Training in People With Parkinson's Disease (NCT NCT02701647)
NCT ID: NCT02701647
Last Updated: 2019-11-22
Results Overview
Each participant is instructed to walk for 14 meters at their fastest walking speed for three trials. The time taken for the middle 10 meter was recorded. The average of three trials is used for analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Baseline, 1 day post-intervention, 1 month post-intervention, 3 month post-intervention
Results posted on
2019-11-22
Participant Flow
Participant milestones
| Measure |
25-Hz rTMS
Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed.
|
1-Hz rTMS
Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed.
|
Sham rTMS
Sham repetitive Transcranial magnetic stimulation was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group was placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect as 25-Hz group. Sham rTMS will be followed by 30 minutes of treadmill training.
Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed.
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|---|---|---|---|
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Overall Study
STARTED
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17
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17
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17
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Overall Study
COMPLETED
|
17
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17
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16
|
|
Overall Study
NOT COMPLETED
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0
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0
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
25-Hz rTMS
n=17 Participants
Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. 80% of participant's over ground maximum walking speed will be halved and used for warm-up. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. Progression will be given if patients could tolerate the belt speed with appropriate step length and walk with good stability for 5 minutes. Maximum achieved speed will be maintained followed by 0.5 km/h decrements. Participants will maintain the rest of the treadmill session with this speed or further adjustment will be made if participants are unable to maintain. Positive verbal feedback
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1-Hz rTMS
n=17 Participants
Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed.
|
Sham rTMS
n=16 Participants
Sham repetitive Transcranial magnetic stimulation was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group will be placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect as 25-Hz group. Sham rTMS will be followed by 30 minutes of treadmill training.
Treadmill training: Participants proceeded with 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. Walking speed on treadmill was increased by 0.2km/h every 5 minutes provided that participants could tolerate the belt speed with appropriate step length and walk with good stability. The maximum achieved speed was then maintained for the rest of the session or adjusted as needed.
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Total
n=50 Participants
Total of all reporting groups
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|---|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
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0 Participants
n=16 Participants
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0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=17 Participants
|
11 Participants
n=17 Participants
|
11 Participants
n=16 Participants
|
35 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=17 Participants
|
6 Participants
n=17 Participants
|
5 Participants
n=16 Participants
|
15 Participants
n=50 Participants
|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 6.8 • n=17 Participants
|
62.1 years
STANDARD_DEVIATION 5.7 • n=17 Participants
|
62.1 years
STANDARD_DEVIATION 5.7 • n=16 Participants
|
62.3 years
STANDARD_DEVIATION 6.0 • n=50 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=17 Participants
|
8 Participants
n=17 Participants
|
9 Participants
n=16 Participants
|
24 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=17 Participants
|
9 Participants
n=17 Participants
|
7 Participants
n=16 Participants
|
26 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
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—
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—
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—
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0 Participants
Race and Ethnicity were not collected from any participant.
|
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Region of Enrollment
Hong Kong
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17 participants
n=17 Participants
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17 participants
n=17 Participants
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16 participants
n=16 Participants
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50 participants
n=50 Participants
|
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Disease duration (no. of years of diagnosis of PD)
|
5.2 years
STANDARD_DEVIATION 3.4 • n=17 Participants
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7.5 years
STANDARD_DEVIATION 4.9 • n=17 Participants
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6.9 years
STANDARD_DEVIATION 3.3 • n=16 Participants
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6.5 years
STANDARD_DEVIATION 4.0 • n=50 Participants
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daily levodopa equivalent dose
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484.2 mg/day
STANDARD_DEVIATION 336.4 • n=17 Participants
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512.5 mg/day
STANDARD_DEVIATION 359.9 • n=17 Participants
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493.3 mg/day
STANDARD_DEVIATION 523.9 • n=16 Participants
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496.8 mg/day
STANDARD_DEVIATION 404.2 • n=50 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 day post-intervention, 1 month post-intervention, 3 month post-interventionEach participant is instructed to walk for 14 meters at their fastest walking speed for three trials. The time taken for the middle 10 meter was recorded. The average of three trials is used for analysis.
Outcome measures
| Measure |
25-Hz rTMS
n=17 Participants
Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
1-Hz rTMS
n=17 Participants
Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
Sham rTMS
n=16 Participants
Sham repetitive Transcranial magnetic stimulation will was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group with another coil placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training.
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|---|---|---|---|
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Fastest Walking Speed
3 month post intervention
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163.2 cm/s
Standard Deviation 31.0
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169.9 cm/s
Standard Deviation 38.7
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156.7 cm/s
Standard Deviation 28.0
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Fastest Walking Speed
Baseline
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149.5 cm/s
Standard Deviation 24.7
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153.1 cm/s
Standard Deviation 27.3
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156.1 cm/s
Standard Deviation 30.2
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Fastest Walking Speed
1 day Post intervention
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164.3 cm/s
Standard Deviation 26.3
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167.3 cm/s
Standard Deviation 34.0
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160.7 cm/s
Standard Deviation 33.3
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Fastest Walking Speed
1 month post intervention
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167.8 cm/s
Standard Deviation 26.4
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170.6 cm/s
Standard Deviation 35.6
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164.6 cm/s
Standard Deviation 32.3
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SECONDARY outcome
Timeframe: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-interventionParticipants are instructed to stand up from a chair and walk for 7 meters walkway and return back to the chair turn around and sit down. Time and gait parameters during TUG were captured by the valid and reliable APDM system, which is a wearable gait and balance analysis system.
Outcome measures
| Measure |
25-Hz rTMS
n=17 Participants
Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
1-Hz rTMS
n=17 Participants
Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
Sham rTMS
n=16 Participants
Sham repetitive Transcranial magnetic stimulation will was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group with another coil placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training.
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|---|---|---|---|
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Timed-Up-and-Go Test (iTUG)
Baseline
|
20.8 seconds
Standard Deviation 4.0
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18.3 seconds
Standard Deviation 2.5
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19.3 seconds
Standard Deviation 2.5
|
|
Timed-Up-and-Go Test (iTUG)
1 day Post intervention
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18.4 seconds
Standard Deviation 2.8
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17.1 seconds
Standard Deviation 2.7
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18.0 seconds
Standard Deviation 2.1
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|
Timed-Up-and-Go Test (iTUG)
1 month post intervention
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17.7 seconds
Standard Deviation 2.9
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17.1 seconds
Standard Deviation 2.3
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17.9 seconds
Standard Deviation 1.8
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Timed-Up-and-Go Test (iTUG)
3 month post intervention
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17.9 seconds
Standard Deviation 2.8
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16.6 seconds
Standard Deviation 2.3
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18.4 seconds
Standard Deviation 2.1
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SECONDARY outcome
Timeframe: Baseline, I day post-intervention, 1 month post-intervention and 3 months post-interventionMDS-UPDRS III is a valid and reliable clinical test, will be used to evaluate severity of motor symptoms of PD. There are total of 27 items including tremor, rigidity, bradykinesia, postural instability and gait performance. Each item scores from 0-4, with 0 indicates no disability and 4 maximum disabled with total score(s) ranges from 0 to 132.
Outcome measures
| Measure |
25-Hz rTMS
n=17 Participants
Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
1-Hz rTMS
n=17 Participants
Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
Sham rTMS
n=16 Participants
Sham repetitive Transcranial magnetic stimulation will was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group with another coil placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training.
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|---|---|---|---|
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the Motor Section of Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS III)
3 month post intervention
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22.5 score on a scale
Standard Deviation 10.1
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21.9 score on a scale
Standard Deviation 7.8
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27.3 score on a scale
Standard Deviation 8.0
|
|
the Motor Section of Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS III)
Baseline
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27.9 score on a scale
Standard Deviation 10.5
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27.1 score on a scale
Standard Deviation 9.6
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29.7 score on a scale
Standard Deviation 10.6
|
|
the Motor Section of Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS III)
1 day Post intervention
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19.9 score on a scale
Standard Deviation 8.5
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22.2 score on a scale
Standard Deviation 7.5
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27.9 score on a scale
Standard Deviation 9.0
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the Motor Section of Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS III)
1 month post intervention
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20.8 score on a scale
Standard Deviation 8.9
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22.5 score on a scale
Standard Deviation 7.3
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27.9 score on a scale
Standard Deviation 10.1
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SECONDARY outcome
Timeframe: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-interventionThe 2 minute walk test will be conducted along a 20 m x 2 m hallway. A line is marked at each end of the walkway to indicate where the person is to turn. Participants will be instructed to " walk as far as possible in 2 minutes". They will be given standardised encouragement at 60 and 90 seconds during walk. Distance walked will be recorded to the nearest meter.
Outcome measures
| Measure |
25-Hz rTMS
n=17 Participants
Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
1-Hz rTMS
n=17 Participants
Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
Sham rTMS
n=16 Participants
Sham repetitive Transcranial magnetic stimulation will was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group with another coil placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training.
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|---|---|---|---|
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Walking Distance in a 2 -Minute Walk Test
Baseline
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147.4 meter
Standard Deviation 29.8
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144.7 meter
Standard Deviation 31.3
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148.7 meter
Standard Deviation 25.0
|
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Walking Distance in a 2 -Minute Walk Test
1 day post intervention
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160.4 meter
Standard Deviation 28.0
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164.9 meter
Standard Deviation 29.8
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157.3 meter
Standard Deviation 31.7
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Walking Distance in a 2 -Minute Walk Test
1 month post intervention
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166.3 meter
Standard Deviation 29.7
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167.9 meter
Standard Deviation 29.7
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157.9 meter
Standard Deviation 29.7
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Walking Distance in a 2 -Minute Walk Test
3 month post intervention
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163.1 meter
Standard Deviation 30.7
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166.8 meter
Standard Deviation 31.2
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160.5 meter
Standard Deviation 28.9
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SECONDARY outcome
Timeframe: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-interventionBalance performance of participants will be assessed in 4 domains namely anticipatory postural adjustments, postural responses, sensory orientation and gait stability. Each item is rated from 0-2 with a total scores of 28. The Total scores range from 0-28, with higher scores indicate better dynamic balance.
Outcome measures
| Measure |
25-Hz rTMS
n=17 Participants
Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
1-Hz rTMS
n=17 Participants
Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
Sham rTMS
n=16 Participants
Sham repetitive Transcranial magnetic stimulation will was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group with another coil placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training.
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|---|---|---|---|
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Mini Balance Evaluation Systems Test Scores
1 day post intervention
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24.2 score on a scale
Standard Deviation 2.5
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23.8 score on a scale
Standard Deviation 2.7
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22.4 score on a scale
Standard Deviation 2.2
|
|
Mini Balance Evaluation Systems Test Scores
Baseline
|
21.5 score on a scale
Standard Deviation 3.4
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21.8 score on a scale
Standard Deviation 2.7
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21.7 score on a scale
Standard Deviation 2.8
|
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Mini Balance Evaluation Systems Test Scores
1 month post intervention
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23.8 score on a scale
Standard Deviation 2.8
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23.5 score on a scale
Standard Deviation 2.5
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22.8 score on a scale
Standard Deviation 2.5
|
|
Mini Balance Evaluation Systems Test Scores
3 month post intervention
|
23.4 score on a scale
Standard Deviation 3.0
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24.1 score on a scale
Standard Deviation 2.6
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23.0 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline, 1 day post-intervention, 1 month post-intervention, 3 month-post interventionFor DT-TUG, participants were instructured to repeat the TUG procedure while performing a serial three substraction. Time taken to complete DT-TUG and accuracy of digital counting was recorded. One practice trial was given prior to both TUG and DT-TUG testing and average performance of three trials was used for analysis.
Outcome measures
| Measure |
25-Hz rTMS
n=17 Participants
Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
1-Hz rTMS
n=17 Participants
Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
Sham rTMS
n=16 Participants
Sham repetitive Transcranial magnetic stimulation will was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group with another coil placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training.
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|---|---|---|---|
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Dual-task Timed-Up-and-Go Test (DT-TUG)
1 month post intervention
|
21.8 seconds
Standard Deviation 6.0
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20.6 seconds
Standard Deviation 4.7
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23.9 seconds
Standard Deviation 3.9
|
|
Dual-task Timed-Up-and-Go Test (DT-TUG)
3 month post intervention
|
22.3 seconds
Standard Deviation 6.0
|
20.3 seconds
Standard Deviation 4.6
|
23.9 seconds
Standard Deviation 3.9
|
|
Dual-task Timed-Up-and-Go Test (DT-TUG)
Baseline
|
27.9 seconds
Standard Deviation 8.8
|
24.0 seconds
Standard Deviation 7.0
|
25.5 seconds
Standard Deviation 5.6
|
|
Dual-task Timed-Up-and-Go Test (DT-TUG)
1 day Post intervention
|
23.1 seconds
Standard Deviation 5.6
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21.1 seconds
Standard Deviation 5.2
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23.4 seconds
Standard Deviation 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-interventionPopulation: 1 discarded data due to poor quality of data
Ten suprathreshold TMS stimuli (i.e. 130% RMT) will be delivered while participant performing a 20% isometric maximal contraction of Tibialis Anterior of the more affected side. Cortical silent period (CSP) measures the duration of interruption of electromyography (EMG) activity in the contracting muscle produced by TMS. CSP duration will be determined as the period between the onset of MEP and the return of baseline EMG activity measured 50 ms before the TMS stimulus.
Outcome measures
| Measure |
25-Hz rTMS
n=17 Participants
Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
1-Hz rTMS
n=17 Participants
Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
Sham rTMS
n=15 Participants
Sham repetitive Transcranial magnetic stimulation will was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group with another coil placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training.
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|---|---|---|---|
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Cortical Silent Period
3 month post intervention
|
175.9 milliseconds
Standard Deviation 43.2
|
154.6 milliseconds
Standard Deviation 46.0
|
182.9 milliseconds
Standard Deviation 35.0
|
|
Cortical Silent Period
Baseline
|
176.5 milliseconds
Standard Deviation 50.0
|
164.6 milliseconds
Standard Deviation 39.8
|
183.9 milliseconds
Standard Deviation 38.9
|
|
Cortical Silent Period
1 day Post intervention
|
194.4 milliseconds
Standard Deviation 53.2
|
180.6 milliseconds
Standard Deviation 39.1
|
175.1 milliseconds
Standard Deviation 46.6
|
|
Cortical Silent Period
1 month post intervention
|
190.1 milliseconds
Standard Deviation 54.5
|
160.1 milliseconds
Standard Deviation 41.1
|
189.2 milliseconds
Standard Deviation 37.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-interventionPopulation: 2 sets of discarded data due to poor quality
TMS stimuli will be applied at 10% steps between 100% to 160% RMT. 10 stimuli will be delivered at each intensity. Peak to peak amplitude of 10 motor-evoked potentials (MEPs) at each stimulus intensity will be averaged offline.The cut-off intensity is set at 75% of maximum stimulator output due to discomfort perceived by majority of the participants. MEPs will be normalised with the maximal muscle action potential (MMax), which is determined by supramaximal electrical stimulation of the fibular nerve. A scatter graph will be generated with the average amplitude of MEPs as a function of stimulation intensity. The linear trend will be added to generate the linear recruitment curve slope.
Outcome measures
| Measure |
25-Hz rTMS
n=17 Participants
Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
1-Hz rTMS
n=16 Participants
Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
Sham rTMS
n=15 Participants
Sham repetitive Transcranial magnetic stimulation will was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group with another coil placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training.
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|---|---|---|---|
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Gradient of the Recruitment Curve ( Also Known as Stimulus-response Curve)
1 month post intervention
|
0.70 millivolts / % maximum stimulator output
Standard Deviation 0.57
|
0.63 millivolts / % maximum stimulator output
Standard Deviation 0.30
|
0.59 millivolts / % maximum stimulator output
Standard Deviation 0.43
|
|
Gradient of the Recruitment Curve ( Also Known as Stimulus-response Curve)
3 month post intervention
|
0.74 millivolts / % maximum stimulator output
Standard Deviation 0.47
|
0.70 millivolts / % maximum stimulator output
Standard Deviation 0.41
|
0.58 millivolts / % maximum stimulator output
Standard Deviation 0.45
|
|
Gradient of the Recruitment Curve ( Also Known as Stimulus-response Curve)
Baseline
|
0.51 millivolts / % maximum stimulator output
Standard Deviation 0.30
|
0.53 millivolts / % maximum stimulator output
Standard Deviation 0.39
|
0.61 millivolts / % maximum stimulator output
Standard Deviation 0.32
|
|
Gradient of the Recruitment Curve ( Also Known as Stimulus-response Curve)
1 day Post intervention
|
0.58 millivolts / % maximum stimulator output
Standard Deviation 0.36
|
0.64 millivolts / % maximum stimulator output
Standard Deviation 0.37
|
0.52 millivolts / % maximum stimulator output
Standard Deviation 0.40
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-interventionPopulation: unable to perform procedure due to small MEPS values for 5 participants
Short-interval-intracortical inhibition (SICI) is another measure of cortical inhibition. In a paired- pulse TMS paradigm, a test pulse will be adjusted to produce MEP of at least 0.5 millivolts which will be delivered preceded by a brief conditioned pulse set at a lower intensity of 80% RMT with inter-stimulus interval of 2 milliseconds. Two stimulators connected via a Bistim module ( Magstim Co.,Whitland, UK) will be used in this test. Ten conditioned MEPs and unconditioned MEPs will be obtained in a random order and were averaged for each condition. SICI is expressed as percentage of unconditioned test MEP amplitude.
Outcome measures
| Measure |
25-Hz rTMS
n=15 Participants
Participants received 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. Participant received a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
|
1-Hz rTMS
n=14 Participants
Participants received a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
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Sham rTMS
n=11 Participants
Sham repetitive Transcranial magnetic stimulation will was applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group with another coil placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training.
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Short-interval-intracortical Inhibition
1 day Post intervention
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44.4 percentage of Unconditioned MEPs
Standard Deviation 23.0
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51.4 percentage of Unconditioned MEPs
Standard Deviation 28.2
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76.5 percentage of Unconditioned MEPs
Standard Deviation 49.8
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Short-interval-intracortical Inhibition
1 month post intervention
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42.0 percentage of Unconditioned MEPs
Standard Deviation 26.9
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62.6 percentage of Unconditioned MEPs
Standard Deviation 31.7
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89.8 percentage of Unconditioned MEPs
Standard Deviation 62.9
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Short-interval-intracortical Inhibition
3 month post intervention
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50.8 percentage of Unconditioned MEPs
Standard Deviation 22.8
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60.7 percentage of Unconditioned MEPs
Standard Deviation 39.2
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74.3 percentage of Unconditioned MEPs
Standard Deviation 30.2
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Short-interval-intracortical Inhibition
Baseline
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56.4 percentage of Unconditioned MEPs
Standard Deviation 27.0
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49.4 percentage of Unconditioned MEPs
Standard Deviation 24.1
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62.2 percentage of Unconditioned MEPs
Standard Deviation 33.1
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Adverse Events
25-Hz rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1-Hz rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place