Trial Outcomes & Findings for A Novel Approach for Brain Stimulation in Severe Stroke (NCT NCT03868410)
NCT ID: NCT03868410
Last Updated: 2025-06-05
Results Overview
Change between Baseline and Post-Test (average 6 weeks) is reported for the UEFM. Impairment will be measured using UEFM, one of the most widely used assessments in stroke. UEFM will serve as our primary outcome because it is sensitive to discerning the effects of rTMS/rehabilitation, and has excellent reliability (ICC= 0.97), consistency (Cronbach's α= 0.84) and validity. UEFM has a score ranging from 0-66 (0 meaning there is no movement of the paretic arm, and 66 meaning there is no functional limitation of the paretic arm.)
COMPLETED
EARLY_PHASE1
16 participants
Change between Baseline and Post-Test (average 6 weeks)
2025-06-05
Participant Flow
Participant milestones
| Measure |
cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
New Approach
New rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
|
iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
Conventional Approach
Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
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|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
New Approach
New rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
|
iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
Conventional Approach
Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
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|---|---|---|
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Overall Study
Physician Decision
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0
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1
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Baseline Characteristics
A Novel Approach for Brain Stimulation in Severe Stroke
Baseline characteristics by cohort
| Measure |
cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=8 Participants
New Approach
New rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
|
iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=8 Participants
Conventional Approach
Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
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Total
n=16 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
64.2 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Stroke Type
hemorrhagic
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Stroke Type
ischemic
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Dominant Paresis
yes
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Dominant Paresis
no
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Active wrist extension
yes
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Active wrist extension
no
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Resting Transcranial Magnetic Stimulation (TMS) Motor Evoked Potential (MEP)
yes
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Resting Transcranial Magnetic Stimulation (TMS) Motor Evoked Potential (MEP)
no
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change between Baseline and Post-Test (average 6 weeks)Change between Baseline and Post-Test (average 6 weeks) is reported for the UEFM. Impairment will be measured using UEFM, one of the most widely used assessments in stroke. UEFM will serve as our primary outcome because it is sensitive to discerning the effects of rTMS/rehabilitation, and has excellent reliability (ICC= 0.97), consistency (Cronbach's α= 0.84) and validity. UEFM has a score ranging from 0-66 (0 meaning there is no movement of the paretic arm, and 66 meaning there is no functional limitation of the paretic arm.)
Outcome measures
| Measure |
cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=8 Participants
New Approach
New rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
|
iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=7 Participants
Conventional Approach
Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
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|---|---|---|
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Change in Upper Extremity Fugyl-Meyer Score (UEFM)
|
2.625 change score from baseline to post-test
Standard Error 0.498
|
2.625 change score from baseline to post-test
Standard Error 0.680
|
PRIMARY outcome
Timeframe: Change between Baseline and Post-Test (average 6 weeks)Inter-hemispheric connectivity (IHI) will be collected with transcranial magnetic stimulation (TMS) and is assessed using ipsilateral silent period (ISP) method. TMS is delivered to the contralesional motor hotspot at supra-maximal intensity (100% maximum stimulator output) while participants maintain sub-maximal contraction (50% maximum volitional contraction) of the ipsilateral paretic extensor digitorum communis muscle for 40 trials. Ipsilateral TMS produces transient suppression of on-going EMG activity, called ISP. ISP is analyzed using an algorithm that compares psotstimulus average rectified EMG to mean consecutive difference (MCD) of background EMG. A threshold of MCD x1.77 below mean background EMG is used to define ISP onset and offset. ISP duration is then calculated as a difference between onset and offset of the ISP.
Outcome measures
| Measure |
cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=8 Participants
New Approach
New rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
|
iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=7 Participants
Conventional Approach
Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
|
|---|---|---|
|
Change in Inter-hemispheric Inhibition (IHI)
|
-8.8774 milliseconds
Standard Error 4.62765
|
3.04521 milliseconds
Standard Error 4.62765
|
SECONDARY outcome
Timeframe: Change between Baseline and Post-Test (average 6 weeks)Change in Functional Ability (FA) from Baseline to Post-Test (average 6 weeks) is reported for the Wolf Motor Function Test. Functional ability (FA) to use the paretic upper limb in a variety of tasks will be assessed using WMFT. FA is scored on a scale from 0-5 with 0 not attempting the task at all and 5 being completely normal movement compared to non paretic limb. 15 items of WMFT are given a FA for the Paretic limb and then the score is averaged to give an overall FA for each participant.
Outcome measures
| Measure |
cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=8 Participants
New Approach
New rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
|
iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=7 Participants
Conventional Approach
Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
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|---|---|---|
|
Change in Wolf Motor Function Test (WMFT) Functional Ability
|
0.083 units on a scale
Standard Error 0.047
|
0.217 units on a scale
Standard Error 0.077
|
SECONDARY outcome
Timeframe: Change between Baseline and Post-Test (average 6 weeks)Change in Rate of the Paretic limb from Baseline to Post-Test (average 6 weeks) is reported for the Wolf Motor Function Test. Time to complete each task will be noted and converted to rate (60/Performance Time (sec)), optimized for measurement in moderately/severely-impaired patients. The rate will be calculated for the Paretic limb \[WMFT Rate (P)\]. The higher the rate the quicker they were able to complete the task.
Outcome measures
| Measure |
cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=8 Participants
New Approach
New rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
|
iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=7 Participants
Conventional Approach
Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
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|---|---|---|
|
Change in Wolf Motor Function Test (WMFT) Rate Paretic Limb
|
0.970 Tasks per minute
Standard Error 0.682
|
2.972 Tasks per minute
Standard Error 1.165
|
SECONDARY outcome
Timeframe: Change between Baseline and Post-Test (average 6 weeks)Change in Rate of the Non-paretic limb from Baseline to Post-Test (average 6 weeks) is reported for the Wolf Motor Function Test. Time to complete each task will be noted and converted to rate (60/Performance Time (sec)), optimized for measurement in moderately/severely-impaired patients. The rate will be calculated for the Non-paretic limb \[WMFT Rate (NP)\]. The higher the rate the quicker they were able to complete the task.
Outcome measures
| Measure |
cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=8 Participants
New Approach
New rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
|
iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=7 Participants
Conventional Approach
Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
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|---|---|---|
|
Change in Wolf Motor Function Test (WMFT) Rate Non-paretic Limb
|
2.552 Tasks per minute
Standard Error 1.048
|
3.098 Tasks per minute
Standard Error 0.977
|
SECONDARY outcome
Timeframe: Change between Baseline and Post-Test (average 6 weeks)Change in the normalized Rate of the Paretic limb to the Non-paretic limb from Baseline to Post-Test (average 6 weeks) is reported for the Wolf Motor Function Test. Time to complete each task will be noted and converted to rate (60/Performance Time (sec)), optimized for measurement in moderately/severely-impaired patients. The rate will be calculated for the Paretic limb normalized to the Non-paretic limb \[WMFT Rate (P/NP)\]. The higher the rate the quicker they were able to complete the task.
Outcome measures
| Measure |
cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=8 Participants
New Approach
New rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
|
iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=7 Participants
Conventional Approach
Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
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|---|---|---|
|
Change in Wolf Motor Function Test (WMFT) Rate Paretic Limb Normalized to the Non-paretic Limb
|
1.593 Tasks per minute
Standard Error 1.477
|
2.921 Tasks per minute
Standard Error 1.306
|
SECONDARY outcome
Timeframe: Change between Baseline and Post-Test (average 6 weeks)Change in total score between Baseline and Post-Test (average 6 weeks) is reported for the Stoke Impact Scale (SIS-16) for each group. Patient's perceived disability related to physical function will be indexed using the Stroke Impact Scale (SIS-16) which a subjective questionnaire asked to the subject pertaining of 16 questions. Each question is rated on scale from 1 to 5 and then the scores are totaled. Total scores can range from 16-80 (16 means that none of the functional tasks asked can be performed, a score of 80 means the subject has no issues at all performing any of the tasks asked).
Outcome measures
| Measure |
cPMD Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=8 Participants
New Approach
New rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
|
iM1 Repetitive Transcranial Magnetic Stimulation (rTMS) + Training
n=7 Participants
Conventional Approach
Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
|
|---|---|---|
|
Change in Stroke Impact Scale (SIS-16)
|
4.250 score on a scale
Standard Error 1.264
|
1.375 score on a scale
Standard Error 1.802
|
SECONDARY outcome
Timeframe: Change between Baseline and Post-Test (average 6 weeks)Functional connectivity will complement IHI measurement as a secondary outcome because while IHI records neurophysiologic interactions between a contralesional and a weak ipsilesional region, functional connectivity defines "global" interactions across multiple regions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change between Baseline and Post-Test (average 6 weeks)Output of uncrossed pathways will be studied as ipsilateral MEPs elicited in the paretic-muscle with TMS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineDiffusion Tensor Imaging (DTI) enables the investigation of structural integrity and orientation of pathways in vivo through the estimation of magnitude and directionality of water diffusion. DTI metrics can help quantitate damage even when patients show no response to Transcranial Magnetic Stimulation (TMS) due to extensive damage (MEP-). Ipsilesional and contralesional corticospinal tracts will be reconstructed using probabilistic tractography. Fractional Anisotropy (FA), a unit-less measure of white matter integrity, will be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change between Baseline and Post-Test (average 6 weeks)Change in total score between Baseline and Post-Test (average 6 weeks) is reported for the Stroke Upper Limb Capacity Scale (SULCS). SULCS is a stroke-specific assessment instrument that evaluates functional capacity of the upper limb based on the execution of 10 tasks. Score ranges from 0-10 where 0 is the lowest level of function in which the participant cannot perform any of the tasks as instructed and 10 is the highest level of function in which all 10 tasks are completed as instructed.
Outcome measures
Outcome data not reported
Adverse Events
cPMD rTMS + Training
iM1 rTMS + Training
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
cPMD rTMS + Training
n=8 participants at risk
New Approach
New rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
|
iM1 rTMS + Training
n=8 participants at risk
Conventional Approach
Conventional rTMS Approach: Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.
|
|---|---|---|
|
Nervous system disorders
headache
|
12.5%
1/8 • Number of events 2 • Each participant was monitored from Baseline assessment through 3 month follow-up (~5.5 months)
|
0.00%
0/8 • Each participant was monitored from Baseline assessment through 3 month follow-up (~5.5 months)
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
12.5%
1/8 • Number of events 1 • Each participant was monitored from Baseline assessment through 3 month follow-up (~5.5 months)
|
12.5%
1/8 • Number of events 1 • Each participant was monitored from Baseline assessment through 3 month follow-up (~5.5 months)
|
|
Nervous system disorders
scalp irritation
|
0.00%
0/8 • Each participant was monitored from Baseline assessment through 3 month follow-up (~5.5 months)
|
12.5%
1/8 • Number of events 1 • Each participant was monitored from Baseline assessment through 3 month follow-up (~5.5 months)
|
|
Nervous system disorders
dizziness/lightheaded
|
12.5%
1/8 • Number of events 1 • Each participant was monitored from Baseline assessment through 3 month follow-up (~5.5 months)
|
12.5%
1/8 • Number of events 1 • Each participant was monitored from Baseline assessment through 3 month follow-up (~5.5 months)
|
|
Cardiac disorders
High Blood Pressure
|
0.00%
0/8 • Each participant was monitored from Baseline assessment through 3 month follow-up (~5.5 months)
|
12.5%
1/8 • Number of events 1 • Each participant was monitored from Baseline assessment through 3 month follow-up (~5.5 months)
|
|
Musculoskeletal and connective tissue disorders
Fall at home
|
0.00%
0/8 • Each participant was monitored from Baseline assessment through 3 month follow-up (~5.5 months)
|
12.5%
1/8 • Number of events 1 • Each participant was monitored from Baseline assessment through 3 month follow-up (~5.5 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place