Trial Outcomes & Findings for Modulating Interaction of Motor Learning Networks in Rehabilitation of Stroke (NCT NCT03086551)
NCT ID: NCT03086551
Last Updated: 2020-04-27
Results Overview
Aggregate time to complete movements between a six sequential targets presented on a computer touch screen in front of the participant. The mean of ten sequences was calculated prior to any practice and at a delayed retention test (e.g. no warm up or preceding practice) post-intervention. Change between the baseline average and post-intervention average was also calculated by subtracting post-intervention score from pre-intervention score. Positive numbers represent improvement in ability.
COMPLETED
NA
12 participants
Baseline and post-intervention
2020-04-27
Participant Flow
Recruitment was conducted through mailings to individuals identified as having been admitted to the University of Michigan Health System in the past 5 years (from 01/01/2012 to 01/27/2017) for treatment of middle cerebral artery stroke. Mailings were sent to those individuals with zip codes in the state of Michigan and northwest Ohio.
Enrolled participants were excluded prior to randomization for: known contraindication to the transcranial magnetic stimulation intervention (n=1) and a broken foot, not study related, between enrollment and randomization (n=1).
Participant milestones
| Measure |
Active+Motor Practice, Then Sham+Motor Practice
Participants first completed four sessions in which motor practice was preceded by ACTIVE continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex. After a three-week washout period participants then completed four sessions in which motor practice was preceded by SHAM continuous theta burst stimulation over dorsolateral prefrontal cortex.
|
Sham+Motor Practice, Then Active+Motor Practice
Participants first completed four sessions in which motor practice was preceded by SHAM continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex. After a three-week washout period participants then completed four sessions in which motor practice was preceded by ACTIVE continuous theta burst stimulation over dorsolateral prefrontal cortex.
|
|---|---|---|
|
First Intervention
STARTED
|
5
|
5
|
|
First Intervention
COMPLETED
|
4
|
4
|
|
First Intervention
NOT COMPLETED
|
1
|
1
|
|
Washout
STARTED
|
4
|
4
|
|
Washout
COMPLETED
|
1
|
1
|
|
Washout
NOT COMPLETED
|
3
|
3
|
|
Second Intervention
STARTED
|
1
|
1
|
|
Second Intervention
COMPLETED
|
1
|
1
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Active+Motor Practice, Then Sham+Motor Practice
Participants first completed four sessions in which motor practice was preceded by ACTIVE continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex. After a three-week washout period participants then completed four sessions in which motor practice was preceded by SHAM continuous theta burst stimulation over dorsolateral prefrontal cortex.
|
Sham+Motor Practice, Then Active+Motor Practice
Participants first completed four sessions in which motor practice was preceded by SHAM continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex. After a three-week washout period participants then completed four sessions in which motor practice was preceded by ACTIVE continuous theta burst stimulation over dorsolateral prefrontal cortex.
|
|---|---|---|
|
First Intervention
Failure to meet inclusion criterion
|
1
|
0
|
|
First Intervention
Lost to Follow-up
|
0
|
1
|
|
Washout
Lost to Follow-up
|
1
|
2
|
|
Washout
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Modulating Interaction of Motor Learning Networks in Rehabilitation of Stroke
Baseline characteristics by cohort
| Measure |
Active+Motor Practice, Then Sham+Motor Practice
n=5 Participants
Participants first completed four sessions in which motor practice was preceded by ACTIVE continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex. After a three-week washout period participants then completed four sessions in which motor practice was preceded by SHAM continuous theta burst stimulation over dorsolateral prefrontal cortex.
|
Sham+Motor Practice, Then Active+Motor Practice
n=5 Participants
Participants first completed four sessions in which motor practice was preceded by SHAM continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex. After a three-week washout period participants then completed four sessions in which motor practice was preceded by ACTIVE continuous theta burst stimulation over dorsolateral prefrontal cortex.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 10 • n=5 Participants
|
59 years
STANDARD_DEVIATION 10 • n=7 Participants
|
58 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Fugl-Meyer Assessment of Motor Recovery After Stroke (Upper Limb)
|
50 units on a scale
STANDARD_DEVIATION 17 • n=5 Participants
|
48 units on a scale
STANDARD_DEVIATION 24 • n=7 Participants
|
49 units on a scale
STANDARD_DEVIATION 20 • n=5 Participants
|
|
Montreal Cognitive Assessment
|
28 units on a scale
STANDARD_DEVIATION 2 • n=5 Participants
|
24 units on a scale
STANDARD_DEVIATION 3 • n=7 Participants
|
26 units on a scale
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Mini-Mental State Examination
|
30 units on a scale
STANDARD_DEVIATION 1 • n=5 Participants
|
27 units on a scale
STANDARD_DEVIATION 3 • n=7 Participants
|
29 units on a scale
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Trail Making Test A
|
29.6 seconds
STANDARD_DEVIATION 6.9 • n=5 Participants
|
31.1 seconds
STANDARD_DEVIATION 13.3 • n=7 Participants
|
30.3 seconds
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Trail Making Test B
|
29.6 seconds
STANDARD_DEVIATION 33.1 • n=5 Participants
|
89.7 seconds
STANDARD_DEVIATION 26.2 • n=7 Participants
|
75.3 seconds
STANDARD_DEVIATION 31.1 • n=5 Participants
|
|
Stroke Affected Hemisphere
Left Hemisphere
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Stroke Affected Hemisphere
Right Hemisphere
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and post-interventionPopulation: All participants who completed at least one arm of the study
Aggregate time to complete movements between a six sequential targets presented on a computer touch screen in front of the participant. The mean of ten sequences was calculated prior to any practice and at a delayed retention test (e.g. no warm up or preceding practice) post-intervention. Change between the baseline average and post-intervention average was also calculated by subtracting post-intervention score from pre-intervention score. Positive numbers represent improvement in ability.
Outcome measures
| Measure |
Active+Motor Practice
n=5 Participants
Participants who received motor practice preceded by ACTIVE continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex in either the first three weeks or last three weeks of the study.
|
Sham+Motor Practice
n=5 Participants
Participants who received motor practice preceded by SHAM continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex in either the first three weeks or last three weeks of the study.
|
|---|---|---|
|
Change From Baseline in Sequential Response Time to Post-Intervention
Time to Complete Sequence (Baseline)
|
8.68 seconds
Standard Deviation 2.06
|
8.84 seconds
Standard Deviation 1.47
|
|
Change From Baseline in Sequential Response Time to Post-Intervention
Time to Complete Sequence (Delayed Retention)
|
8.32 seconds
Standard Deviation 1.55
|
7.96 seconds
Standard Deviation 1.04
|
|
Change From Baseline in Sequential Response Time to Post-Intervention
Change in Time (Pre to Post)
|
0.37 seconds
Standard Deviation 0.65
|
0.88 seconds
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Baseline and post-interventionPopulation: All participants who completed at least one arm of the study
The Jebsen-Taylor Hand Function Test is comprised of a series of unimanual tasks required for activities of daily living. Time to complete the Jebsen-Taylor Hand Function Test was assessed at baseline and post-intervention by taking the aggregate time to complete each activity. Change in time to complete the Jebsen-Taylor Hand Function Test between the baseline and post-intervention tests was derived by subtracting post-intervention score from baseline score. Positive scores indicate improvement in functional motor ability.
Outcome measures
| Measure |
Active+Motor Practice
n=5 Participants
Participants who received motor practice preceded by ACTIVE continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex in either the first three weeks or last three weeks of the study.
|
Sham+Motor Practice
n=5 Participants
Participants who received motor practice preceded by SHAM continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex in either the first three weeks or last three weeks of the study.
|
|---|---|---|
|
Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test
Pre Time to Complete (Stroke Affected Limb)
|
95.68 seconds
Standard Deviation 51.71
|
86.07 seconds
Standard Deviation 17.78
|
|
Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test
Post Time to Complete (Stroke Affected Limb)
|
100.05 seconds
Standard Deviation 60.47
|
76.27 seconds
Standard Deviation 20.97
|
|
Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test
Change Pre to Post (Stroke Affected Limb)
|
-4.38 seconds
Standard Deviation 8.95
|
9.80 seconds
Standard Deviation 6.14
|
|
Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test
Pre Time to Complete (Non-Stroke Affected Limb)
|
55.75 seconds
Standard Deviation 11.22
|
66.67 seconds
Standard Deviation 20.87
|
|
Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test
Post Time to Complete (Non-Stroke Affected Limb)
|
51.97 seconds
Standard Deviation 8.25
|
64.95 seconds
Standard Deviation 24.07
|
|
Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test
Change Pre to Post (Non-Stroke Affected Limb)
|
3.78 seconds
Standard Deviation 5.33
|
1.72 seconds
Standard Deviation 5.40
|
SECONDARY outcome
Timeframe: Within session baseline to ~8 minutes post-application of non-invasive stimulation within the same sessionPopulation: All participants who completed at least one arm of the study
Aggregate time to complete movements between a six sequential targets presented on a computer touch screen in front of the participant. The mean of ten sequences was calculated prior to application of Active+Motor Practice or Sham+Motor Practice for each intervention session and the first ten sequences of practice immediately following the specific form of non-invasive brain stimulation within each session. Change within a session was calculated by subtracting the post-stimulation score from the pre-stimulation score within a session. Positive values represent improved ability.
Outcome measures
| Measure |
Active+Motor Practice
n=5 Participants
Participants who received motor practice preceded by ACTIVE continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex in either the first three weeks or last three weeks of the study.
|
Sham+Motor Practice
n=5 Participants
Participants who received motor practice preceded by SHAM continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex in either the first three weeks or last three weeks of the study.
|
|---|---|---|
|
Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session)
Session 1
|
0.41 seconds
Standard Deviation 0.70
|
0.89 seconds
Standard Deviation 0.36
|
|
Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session)
Session 2
|
0.72 seconds
Standard Deviation 1.97
|
0.80 seconds
Standard Deviation 1.86
|
|
Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session)
Session 3
|
-0.20 seconds
Standard Deviation 0.60
|
0.22 seconds
Standard Deviation 0.62
|
|
Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session)
Session 4
|
0.35 seconds
Standard Deviation 0.46
|
0.23 seconds
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Baseline and post-interventionPopulation: All participants who completed at least one arm of the study
Motor evoked potential amplitude evoked by transcranial magnetic brain stimulation was recorded using electromyography over the first dorsal interosseous muscle of the stroke-affected hand. The means of ten trials at 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshold were calculated and expressed in microvolts.
Outcome measures
| Measure |
Active+Motor Practice
n=5 Participants
Participants who received motor practice preceded by ACTIVE continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex in either the first three weeks or last three weeks of the study.
|
Sham+Motor Practice
n=5 Participants
Participants who received motor practice preceded by SHAM continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex in either the first three weeks or last three weeks of the study.
|
|---|---|---|
|
Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention
MEP Amplitude Pre (120% of RMT)
|
1558 microvolts
Standard Deviation 1020
|
971 microvolts
Standard Deviation 709
|
|
Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention
MEP Amplitude Post (120% of RMT)
|
1216 microvolts
Standard Deviation 1161
|
511 microvolts
Standard Deviation 279
|
|
Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention
MEP Amplitude Pre (150% of RMT)
|
2750 microvolts
Standard Deviation 2172
|
1977 microvolts
Standard Deviation 218
|
|
Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention
MEP Amplitude Post (150% of RMT)
|
2008 microvolts
Standard Deviation 2062
|
2495 microvolts
Standard Deviation 609
|
SECONDARY outcome
Timeframe: Baseline and post-interventionPopulation: All participants who completed at least one arm of the study
Motor evoked potential amplitude evoked by transcranial magnetic brain stimulation was recorded using electromyography over the first dorsal interosseous muscle of the stroke-affected hand. The means of ten trials at 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshold were calculated and expressed in microvolts. Change in motor evoked potential amplitude elicited by transcranial magnetic stimulation intensities of 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshold. Values are expressed percent change relative to pre-baseline values. Positive numbers represent an increase motor evoked potential from pre-baseline to post-intervention.
Outcome measures
| Measure |
Active+Motor Practice
n=5 Participants
Participants who received motor practice preceded by ACTIVE continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex in either the first three weeks or last three weeks of the study.
|
Sham+Motor Practice
n=5 Participants
Participants who received motor practice preceded by SHAM continuous theta burst stimulation (cTBS) over dorsolateral prefrontal cortex in either the first three weeks or last three weeks of the study.
|
|---|---|---|
|
Change From Baseline in Cortical Excitability Post-Intervention
% change in MEP (120% RMT)
|
-26 percentage change
Standard Deviation 35
|
-19 percentage change
Standard Deviation 58
|
|
Change From Baseline in Cortical Excitability Post-Intervention
% change in MEP (150% RMT)
|
-17 percentage change
Standard Deviation 37
|
25 percentage change
Standard Deviation 17
|
Adverse Events
Active+Motor Practice
Sham+Motor Practice
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sean K Meehan, PhD
University of Waterloo, Waterloo, Ontario, Canada
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place