Trial Outcomes & Findings for Adjunct Low Frequency Repetitive Transcranial Magnetic Stimulation With Physiotherapy Enhance Upper Extremity Function Restoration (NCT NCT02490371)
NCT ID: NCT02490371
Last Updated: 2019-09-26
Results Overview
Electromyographic (EMG) activity in first doral interossei measured at 120% resting motor threshold. The motor evoked potential amplitude will be measured peak to peak in millivolt(mV). Higher value mean better control
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Baseline and at 4th weeks and at 12th weeks
Results posted on
2019-09-26
Participant Flow
A convenient sampling method was adopted. Patients who were diagnosed with their first-ever stroke and referred to the Physiotherapy Department at Queen Elizabeth Hospital for post-stroke rehabilitation between November 2015 to December 2016 were screened for eligibility by an independent physiotherapist using inclusion criterias.
Exclusion criteria: 1. Mini Mental State Test score ≤ 24; 2. Mental illness; 3. Contra-indications to rTMS according to guidelines formulated by Wassermann (e.g., intracranial implants, epilepsy, cardiac pacemaker, implanted medication pumps); 4 Unstable cardio-pulmonary condition.
Participant milestones
| Measure |
(1) rTMS- PT Ex Group
1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse (20 minutes) at 90% resting motor threshold (rMT) will conduct for 10 consecutive sessions (5 days per week for 2 weeks) and immediately followed by 30- minutes structured physiotherapy upper limb training.
After the 10 sessions of brain stimulation, the 30-minute structured physiotherapy upper limb training program will continue for another 12 weeks (2 sessions per week)
Low frequency rTMS: 1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.
structured physiotherapy upper limb training: Structural Physiotherapy upper limb training for 30-minutes
|
(2) Placebo- PT Ex Group
placebo stimulation over contra-lesional M1 region will be conducted for 10 consecutive sessions (5 sessions per week for 2 weeks) of and immediately followed by 30- minutes of structured physiotherapy upper limb training.
Then, the structured physiotherapy upper limb training will continue for another 12 weeks (2 sessions per week).
Low frequency rTMS: 1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.
structured physiotherapy upper limb training: Structural Physiotherapy upper limb training for 30-minutes
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
(1) rTMS- PT Ex Group
1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse (20 minutes) at 90% resting motor threshold (rMT) will conduct for 10 consecutive sessions (5 days per week for 2 weeks) and immediately followed by 30- minutes structured physiotherapy upper limb training.
After the 10 sessions of brain stimulation, the 30-minute structured physiotherapy upper limb training program will continue for another 12 weeks (2 sessions per week)
Low frequency rTMS: 1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.
structured physiotherapy upper limb training: Structural Physiotherapy upper limb training for 30-minutes
|
(2) Placebo- PT Ex Group
placebo stimulation over contra-lesional M1 region will be conducted for 10 consecutive sessions (5 sessions per week for 2 weeks) of and immediately followed by 30- minutes of structured physiotherapy upper limb training.
Then, the structured physiotherapy upper limb training will continue for another 12 weeks (2 sessions per week).
Low frequency rTMS: 1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.
structured physiotherapy upper limb training: Structural Physiotherapy upper limb training for 30-minutes
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
(1) rTMS- PT Ex Group
n=12 Participants
1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse (20 minutes) at 90% resting motor threshold (rMT) will conduct for 10 consecutive sessions (5 days per week for 2 weeks) and immediately followed by 30- minutes structured physiotherapy upper limb training.
After the 10 sessions of brain stimulation, the 30-minute structured physiotherapy upper limb training program will continue for another 12 weeks (2 sessions per week)
Low frequency rTMS: 1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.
structured physiotherapy upper limb training: Structural Physiotherapy upper limb training for 30-minutes
|
(2) Placebo- PT Ex Group
n=12 Participants
placebo stimulation over contra-lesional M1 region will be conducted for 10 consecutive sessions (5 sessions per week for 2 weeks) of and immediately followed by 30- minutes of structured physiotherapy upper limb training.
Then, the structured physiotherapy upper limb training will continue for another 12 weeks (2 sessions per week).
Low frequency rTMS: 1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.
structured physiotherapy upper limb training: Structural Physiotherapy upper limb training for 30-minutes
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 5.8 • n=12 Participants
|
65.1 years
STANDARD_DEVIATION 3.1 • n=12 Participants
|
66.2 years
STANDARD_DEVIATION 4.7 • n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
10 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
14 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Hong Kong
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
24 participants
n=24 Participants
|
|
Time since stroke (weeks)
|
13.6 years
STANDARD_DEVIATION 5.8 • n=12 Participants
|
15.1 years
STANDARD_DEVIATION 7 • n=12 Participants
|
14.3 years
STANDARD_DEVIATION 6.5 • n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline and at 4th weeks and at 12th weeksElectromyographic (EMG) activity in first doral interossei measured at 120% resting motor threshold. The motor evoked potential amplitude will be measured peak to peak in millivolt(mV). Higher value mean better control
Outcome measures
| Measure |
rTMS Group + Exercise
n=12 Participants
Patient with rTMS and 30 minutes exercise
|
Placebo+ Exercise
n=12 Participants
Placebo stimulation with exercise
|
|---|---|---|
|
Change of Cortical Excitability From Baseline to at 4th Weeksand 12th Weeks Training in Motor Evoked Potential at 120% Resting MotorThreshold at Affected Hand
Baseline
|
258.3 millivolt
Standard Deviation 278
|
600 millivolt
Standard Deviation 374.6
|
|
Change of Cortical Excitability From Baseline to at 4th Weeksand 12th Weeks Training in Motor Evoked Potential at 120% Resting MotorThreshold at Affected Hand
At 4th week
|
323.3 millivolt
Standard Deviation 279.5
|
565 millivolt
Standard Deviation 371.7
|
|
Change of Cortical Excitability From Baseline to at 4th Weeksand 12th Weeks Training in Motor Evoked Potential at 120% Resting MotorThreshold at Affected Hand
At 12th week
|
369.1 millivolt
Standard Deviation 244.6
|
586 millivolt
Standard Deviation 384.9
|
SECONDARY outcome
Timeframe: Baseline and at 4th weeks and at 12th weeksFugl-Meyer Assessment (FM) scale is a stroke-specific, performance-based impairment index, the scale range from 0 to 66. 25 test items included measurement of movement, coordination, and reflex action of the different parts of the paretic upper extremity. The score could range from 0 to 66. Better motor function was reflected by a higher FMA score
Outcome measures
| Measure |
rTMS Group + Exercise
n=12 Participants
Patient with rTMS and 30 minutes exercise
|
Placebo+ Exercise
n=12 Participants
Placebo stimulation with exercise
|
|---|---|---|
|
Change of Upper Limb Impairment From Baseline to at 4th Weeks & 12 th Weeks Training in Fugl-Meyer Assessment (FM) Scale
Baseline
|
46.7 score on a scale
Standard Deviation 13.9
|
48.8 score on a scale
Standard Deviation 14.9
|
|
Change of Upper Limb Impairment From Baseline to at 4th Weeks & 12 th Weeks Training in Fugl-Meyer Assessment (FM) Scale
At 4th week
|
52.3 score on a scale
Standard Deviation 11.9
|
49.9 score on a scale
Standard Deviation 15.3
|
|
Change of Upper Limb Impairment From Baseline to at 4th Weeks & 12 th Weeks Training in Fugl-Meyer Assessment (FM) Scale
At 12th week
|
57.0 score on a scale
Standard Deviation 9.6
|
53.3 score on a scale
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: Baseline and at 4th weeks and at 12th weeksIsometric hand grip strength will be measured using the hand-held dynamometer in kilogram (kg). Higher value reflect better hand grip strength
Outcome measures
| Measure |
rTMS Group + Exercise
n=12 Participants
Patient with rTMS and 30 minutes exercise
|
Placebo+ Exercise
n=12 Participants
Placebo stimulation with exercise
|
|---|---|---|
|
Change of Grip Strength From Baseline to at 4th Weeks and at 12th Weeks Training in Force (Kilogram )
Baseline
|
12.6 kilgograms
Standard Deviation 11.3
|
13.8 kilgograms
Standard Deviation 10.8
|
|
Change of Grip Strength From Baseline to at 4th Weeks and at 12th Weeks Training in Force (Kilogram )
At 4th week
|
13.9 kilgograms
Standard Deviation 10.8
|
13.9 kilgograms
Standard Deviation 10.5
|
|
Change of Grip Strength From Baseline to at 4th Weeks and at 12th Weeks Training in Force (Kilogram )
At 12th week
|
15.4 kilgograms
Standard Deviation 10.1
|
14.4 kilgograms
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Baseline and at 4th weeks and at 12th weeksThe 19-item Action Research Arm Test has four subscales that assess various aspects of upper limb function (i.e., pinch, grip, grasp, and gross motor). Each item was rated on a 4-point scale from 0 to 3. Scale from 0 to 57.A higher score was indicative of better upper limb function.
Outcome measures
| Measure |
rTMS Group + Exercise
n=12 Participants
Patient with rTMS and 30 minutes exercise
|
Placebo+ Exercise
n=12 Participants
Placebo stimulation with exercise
|
|---|---|---|
|
Change of Upper Limb Function From Baseline to at 4th Weeks Training in Action Research Arm Test (ARAT) Scale
Baseline
|
36.5 units on a scale
Standard Deviation 17.8
|
41.1 units on a scale
Standard Deviation 17.8
|
|
Change of Upper Limb Function From Baseline to at 4th Weeks Training in Action Research Arm Test (ARAT) Scale
At 4th week
|
45.4 units on a scale
Standard Deviation 11.4
|
41.1 units on a scale
Standard Deviation 1.13
|
|
Change of Upper Limb Function From Baseline to at 4th Weeks Training in Action Research Arm Test (ARAT) Scale
At 12th week
|
51.1 units on a scale
Standard Deviation 8.9
|
43.2 units on a scale
Standard Deviation 17.9
|
SECONDARY outcome
Timeframe: Baseline and at 4th weeks and at 12th weeksA simple reaction time will be recorded through a computer system. Time for the patient to reaction to the signal will be measured in seconds (sec). Shorter period of time reflect better reaction time.Lower score means better result
Outcome measures
| Measure |
rTMS Group + Exercise
n=12 Participants
Patient with rTMS and 30 minutes exercise
|
Placebo+ Exercise
n=12 Participants
Placebo stimulation with exercise
|
|---|---|---|
|
Change of Reaction Time From Baseline to at 4th Weeks and at 12th Weeks Training in Time Measurement (Seconds)
Baseline
|
985.8 seconds
Standard Deviation 439.9
|
654.2 seconds
Standard Deviation 285.5
|
|
Change of Reaction Time From Baseline to at 4th Weeks and at 12th Weeks Training in Time Measurement (Seconds)
At 4th week
|
902.2 seconds
Standard Deviation 398.6
|
651.7 seconds
Standard Deviation 285.4
|
|
Change of Reaction Time From Baseline to at 4th Weeks and at 12th Weeks Training in Time Measurement (Seconds)
At 12th week
|
837.3 seconds
Standard Deviation 309.1
|
637.9 seconds
Standard Deviation 291.2
|
SECONDARY outcome
Timeframe: Baseline and at 4th & 12 th weeksThe 59-item Stroke Impact Scale (SIS) is a stroke-specific, self-report, health status measure. Total range from 0 to 100. Higher score reflect better result.
Outcome measures
| Measure |
rTMS Group + Exercise
n=12 Participants
Patient with rTMS and 30 minutes exercise
|
Placebo+ Exercise
n=12 Participants
Placebo stimulation with exercise
|
|---|---|---|
|
Change of Health Status Measurement From Baseline to at 4th Weeks and at 12th Weeks in Stroke Impact Scale
At 12th week
|
68.4 score on a scale
Standard Deviation 6.9
|
72.7 score on a scale
Standard Deviation 11.6
|
|
Change of Health Status Measurement From Baseline to at 4th Weeks and at 12th Weeks in Stroke Impact Scale
Baseline
|
59 score on a scale
Standard Deviation 13.3
|
65.7 score on a scale
Standard Deviation 10.3
|
|
Change of Health Status Measurement From Baseline to at 4th Weeks and at 12th Weeks in Stroke Impact Scale
At 4th week
|
64.1 score on a scale
Standard Deviation 8.5
|
69.6 score on a scale
Standard Deviation 11.2
|
Adverse Events
(1) rTMS- PT Ex Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
(2) Placebo- PT Ex Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
(1) rTMS- PT Ex Group
n=12 participants at risk
1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse (20 minutes) at 90% resting motor threshold (rMT) will conduct for 10 consecutive sessions (5 days per week for 2 weeks) and immediately followed by 30- minutes structured physiotherapy upper limb training.
After the 10 sessions of brain stimulation, the 30-minute structured physiotherapy upper limb training program will continue for another 12 weeks (2 sessions per week)
Low frequency rTMS: 1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.
structured physiotherapy upper limb training: Structural Physiotherapy upper limb training for 30-minutes
|
(2) Placebo- PT Ex Group
n=12 participants at risk
placebo stimulation over contra-lesional M1 region will be conducted for 10 consecutive sessions (5 sessions per week for 2 weeks) of and immediately followed by 30- minutes of structured physiotherapy upper limb training.
Then, the structured physiotherapy upper limb training will continue for another 12 weeks (2 sessions per week).
Low frequency rTMS: 1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.
structured physiotherapy upper limb training: Structural Physiotherapy upper limb training for 30-minutes
|
|---|---|---|
|
Nervous system disorders
seizure
|
0.00%
0/12 • Adverse event during the rTMS stimulation , following the whole study period included at 4th weeks up to end of study period at 12th weeks had been reported and recorded.
Headache, seizure
|
0.00%
0/12 • Adverse event during the rTMS stimulation , following the whole study period included at 4th weeks up to end of study period at 12th weeks had been reported and recorded.
Headache, seizure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place