Trial Outcomes & Findings for Customized Cortical Stimulation Therapy in the Rehabilitation of Stroke Patients (NCT NCT02544503)
NCT ID: NCT02544503
Last Updated: 2023-08-31
Results Overview
The Jebsen Test assesses weighted and non-weighted hand function among participants who have had a stroke. Subjects are assessed through writing, turning over 3 by 5 inch cards, picking up small common objects, simulated feeding, stacking checkers, picking up large objects, and picking up large heavy objects. Patients are required to perform all of the subtests with both the right and left hands. Time to complete each task is recorded and normalized to healthy age and sex matched control subjects. The score ranges from 0 to 1 with 0 being normal.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
1 month post-stroke (subacute stroke), 6 months post-stroke (chronic stroke)
Results posted on
2023-08-31
Participant Flow
Participants were recruited at Emory University in Atlanta, Georgia, USA. Participant enrollment began in July 2015 and all follow-up assessments were completed by February 4, 2021.
Individuals provided consent to participate and were enrolled into study arms based on their health status (prior stroke or health control). After enrolling, 24 individuals with stroke and 3 healthy controls did not meet eligibility criteria and did not participate in any study assessments. Participants with stroke were assessed one and six months after their stroke, while healthy controls participated in a single assessment.
Participant milestones
| Measure |
Stroke Patients
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
34
|
|
Overall Study
Completed First Study Assessment
|
42
|
31
|
|
Overall Study
Stroke Patients Who Completed the 6 Month Post-stroke Assessment
|
32
|
0
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
34
|
3
|
Reasons for withdrawal
| Measure |
Stroke Patients
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
Overall Study
Screen fail; these participants did not take part in the 1 month assessment
|
24
|
3
|
|
Overall Study
Lost to Follow-up
|
9
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Customized Cortical Stimulation Therapy in the Rehabilitation of Stroke Patients
Baseline characteristics by cohort
| Measure |
Stroke Patients
n=42 Participants
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
n=31 Participants
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.83 years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
61.68 years
STANDARD_DEVIATION 8.65 • n=7 Participants
|
60.94 years
STANDARD_DEVIATION 9.21 • n=5 Participants
|
|
Age, Customized
Age, categorical · Less than 40
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Age, categorical · 40 - 80
|
42 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
24 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 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
|
2 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month post-stroke (subacute stroke), 6 months post-stroke (chronic stroke)Population: This analysis includes participants who completed this assessment at the indicated study visit.
The Jebsen Test assesses weighted and non-weighted hand function among participants who have had a stroke. Subjects are assessed through writing, turning over 3 by 5 inch cards, picking up small common objects, simulated feeding, stacking checkers, picking up large objects, and picking up large heavy objects. Patients are required to perform all of the subtests with both the right and left hands. Time to complete each task is recorded and normalized to healthy age and sex matched control subjects. The score ranges from 0 to 1 with 0 being normal.
Outcome measures
| Measure |
Stroke Patients
n=32 Participants
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
Motor Function Assessed by the Jebsen Test
More affected hand - subacute stroke
|
0.49 score on a scale
Standard Deviation 0.32
|
—
|
|
Motor Function Assessed by the Jebsen Test
Less affected hand - subacute stroke
|
0.14 score on a scale
Standard Deviation 0.10
|
—
|
|
Motor Function Assessed by the Jebsen Test
More affected hand - chronic stroke
|
0.35 score on a scale
Standard Deviation 0.31
|
—
|
|
Motor Function Assessed by the Jebsen Test
Less affected hand - chronic stroke
|
0.11 score on a scale
Standard Deviation 0.09
|
—
|
PRIMARY outcome
Timeframe: 1 month post-stroke (subacute stroke) or single study visit for healthy controls, 6 months post-stroke (chronic stroke)Population: This analysis includes participants completing the assessment at the indicated time point.
Change in mean motor evoked potential (MEP) amplitudes at each stimulus intensity will be calculated. The sum of these means is calculated as the area under the curve.
Outcome measures
| Measure |
Stroke Patients
n=35 Participants
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
n=12 Participants
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
Mean Motor Evoked Potential (MEP) Amplitudes Assessed by Stimulus Response Curve (SRC) of the Contralesional M1
Subacute stroke or single visit for healthy controls
|
0.67 mV
Standard Deviation 0.75
|
0.63 mV
Standard Deviation 0.85
|
|
Mean Motor Evoked Potential (MEP) Amplitudes Assessed by Stimulus Response Curve (SRC) of the Contralesional M1
Chronic stroke
|
0.39 mV
Standard Deviation 0.63
|
—
|
PRIMARY outcome
Timeframe: 1 month post-stroke (subacute stroke), 6 months post-stroke (chronic stroke)Population: This analysis includes participants who completed the assessment at the indicated time point.
The presence of motor evoked potential (MEP) in response to maximum TMS applied to ipsilesional M1 was determined in participants with stroke.
Outcome measures
| Measure |
Stroke Patients
n=35 Participants
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
Presence of MEP in Response to TMS of the Ipsilesional M1
Subacute stroke · Not Present
|
11 Participants
|
—
|
|
Presence of MEP in Response to TMS of the Ipsilesional M1
Subacute stroke · Present
|
24 Participants
|
—
|
|
Presence of MEP in Response to TMS of the Ipsilesional M1
Chronic stroke · Not Present
|
3 Participants
|
—
|
|
Presence of MEP in Response to TMS of the Ipsilesional M1
Chronic stroke · Present
|
22 Participants
|
—
|
PRIMARY outcome
Timeframe: 1 month post-stroke (subacute stroke)Population: This analysis includes participants with stroke who completed this assessment.
Normalized stroke lesion volume was determined at the one-month time point using structural MRI of the brain.
Outcome measures
| Measure |
Stroke Patients
n=35 Participants
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
Lesion Volume
|
19745 cubic mm
Standard Deviation 32285
|
—
|
PRIMARY outcome
Timeframe: 1 month post-stroke (subacute stroke)Population: This analysis includes participants with stroke who completed this assessment.
Corticospinal tract (CST) lesion load will be determined at the one-month time point using structural MRI of the brain. The lesion size is expressed as percentage of the entire CST.
Outcome measures
| Measure |
Stroke Patients
n=35 Participants
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
Corticospinal Tract (CST) Lesion
|
5.7 percent of CST
Standard Deviation 6.77
|
—
|
SECONDARY outcome
Timeframe: 1 month post-stroke (subacute stroke), 6 months post-stroke (chronic stroke)Population: This analysis includes participants who completed this assessment at the indicated study visit.
Upper extremity motor ability among participants who had a stroke was evaluated with the Wolf Motor Function Test (WMFT). The test consists of 17 items (6 joint-segment movements, 9 integrative functional movements and 2 strength items). The items are rated on a 6-point functional ability scale (FAS) where 0 is "no attempt is made to use the more affected arm and 5 is a normal appearance of movement execution. The time taken to complete each task will be recorded up to 120 seconds. The mean time to complete all tasks will be used to evaluate motor ability.
Outcome measures
| Measure |
Stroke Patients
n=39 Participants
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
Motor Function Assessed by Time to Complete the Wolf Motor Function Test (WMFT)
Less affected side - subacute stroke
|
7.11 seconds
Standard Deviation 9.49
|
—
|
|
Motor Function Assessed by Time to Complete the Wolf Motor Function Test (WMFT)
More affected side - subacute stroke
|
36.82 seconds
Standard Deviation 7.55
|
—
|
|
Motor Function Assessed by Time to Complete the Wolf Motor Function Test (WMFT)
Less affected side - chronic stroke
|
3.42 seconds
Standard Deviation 4.86
|
—
|
|
Motor Function Assessed by Time to Complete the Wolf Motor Function Test (WMFT)
More affected side - chronic stroke
|
18.44 seconds
Standard Deviation 4.81
|
—
|
SECONDARY outcome
Timeframe: 1 month post-stroke (subacute stroke), 6 months post-stroke (chronic stroke)Population: This analysis includes participants completing the assessment at the indicated time point.
During the grip strength assessment of the WMFT, participants grip a dynamometer with as much strength as possible. There are three trials of gripping with a minute rest interval between trials. The mean kilograms of strength exerted during the three trials is calculated.
Outcome measures
| Measure |
Stroke Patients
n=39 Participants
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
Motor Function Assessed by Grip Strength During the Wolf Motor Function Test (WMFT)
Less affected side - subacute stroke
|
28.95 kilograms
Standard Deviation 10.88
|
—
|
|
Motor Function Assessed by Grip Strength During the Wolf Motor Function Test (WMFT)
More affected side - subacute stroke
|
15.25 kilograms
Standard Deviation 15.70
|
—
|
|
Motor Function Assessed by Grip Strength During the Wolf Motor Function Test (WMFT)
Less affected side - chronic stroke
|
29.94 kilograms
Standard Deviation 8.06
|
—
|
|
Motor Function Assessed by Grip Strength During the Wolf Motor Function Test (WMFT)
More affected side - chronic stroke
|
17.03 kilograms
Standard Deviation 12.68
|
—
|
SECONDARY outcome
Timeframe: 1 month post-stroke (subacute stroke), 6 months post-stroke (chronic stroke)Population: This analysis includes participants with stroke who completed the assessment during the indicated study visit.
In stroke patients, the everyday use of the paretic (the more affected) arm will be measured using the Motor Activity Log (MAL). The MAL is a subjective measure of semi- structured interview to examine a) how much and b) how well the subject uses their more-affected arm outside of the laboratory setting. Total scores range from 0 (no use of the more-affected arm) to 5 (use is as good as before stroke).
Outcome measures
| Measure |
Stroke Patients
n=35 Participants
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
Use of Paretic Arm Assessed by the Motor Activity Log (MAL)
Amount of use, subacute stroke
|
2.044 score on a scale
Standard Deviation 1.654
|
—
|
|
Use of Paretic Arm Assessed by the Motor Activity Log (MAL)
Quality of movement, subacute stroke
|
1.939 score on a scale
Standard Deviation 1.593
|
—
|
|
Use of Paretic Arm Assessed by the Motor Activity Log (MAL)
Amount of use, chronic stroke
|
3.266 score on a scale
Standard Deviation 1.625
|
—
|
|
Use of Paretic Arm Assessed by the Motor Activity Log (MAL)
Quality of movement, chronic stroke
|
3.275 score on a scale
Standard Deviation 1.597
|
—
|
SECONDARY outcome
Timeframe: 1 month post-stroke (subacute stroke)Population: This analysis includes participants with stroke who completed this assessment.
CST sub M1 lesion volume will be determined at the one- month time point using structural MRI of the brain. The lesion load is expressed as percentage of the entire CST.
Outcome measures
| Measure |
Stroke Patients
n=35 Participants
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
CST Subpathway Originating in M1 Lesion Load
|
5.07 percentage of the entire CST
Standard Deviation 6.48
|
—
|
SECONDARY outcome
Timeframe: 1 month post-stroke (subacute stroke) or single study visit for healthy controls, 6 months post-stroke (chronic stroke)Population: This analysis includes participants completing the assessment at the indicated time point.
Functional Magnetic Resonance Imaging (fMRI) will be used to determine hand movement related activity in the motor cortex of the brain in all subjects. Blood oxygenation level dependent (BOLD) response during execution of the motor task will be compared to rest. The subacute stroke and chronic stroke time points are compared to single study visit of healthy controls.
Outcome measures
| Measure |
Stroke Patients
n=19 Participants
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
n=31 Participants
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
Primary Motor Cortex (M1) Activity, Assessed by Functional Magnetic Resonance Imaging (fMRI)
Ipsilesional - subacute stroke
|
1.33 Percent signal change
Standard Deviation 1.10
|
—
|
|
Primary Motor Cortex (M1) Activity, Assessed by Functional Magnetic Resonance Imaging (fMRI)
Contralesional - subacute stroke
|
0.14 Percent signal change
Standard Deviation 0.41
|
—
|
|
Primary Motor Cortex (M1) Activity, Assessed by Functional Magnetic Resonance Imaging (fMRI)
Contralateral Left - single visit for healthy controls
|
—
|
1.59 Percent signal change
Standard Deviation 0.75
|
|
Primary Motor Cortex (M1) Activity, Assessed by Functional Magnetic Resonance Imaging (fMRI)
Contralateral Right - single visit for healthy controls
|
—
|
1.59 Percent signal change
Standard Deviation 0.82
|
|
Primary Motor Cortex (M1) Activity, Assessed by Functional Magnetic Resonance Imaging (fMRI)
Ipsilateral Left - single visit for healthy controls
|
—
|
0.27 Percent signal change
Standard Deviation 0.55
|
|
Primary Motor Cortex (M1) Activity, Assessed by Functional Magnetic Resonance Imaging (fMRI)
Ipsilateral Right - single visit for healthy controls
|
—
|
0.17 Percent signal change
Standard Deviation 0.36
|
|
Primary Motor Cortex (M1) Activity, Assessed by Functional Magnetic Resonance Imaging (fMRI)
Ipsilesional - chronic stroke
|
0.68 Percent signal change
Standard Deviation 0.52
|
—
|
|
Primary Motor Cortex (M1) Activity, Assessed by Functional Magnetic Resonance Imaging (fMRI)
Contralesional - chronic stroke
|
0.03 Percent signal change
Standard Deviation 0.27
|
—
|
SECONDARY outcome
Timeframe: 1 month post-stroke (subacute stroke) or single study visit for healthy controls, 6 months post-stroke (chronic stroke)Population: This analysis includes participants completing the assessment at the indicated study visit.
SICI in the contralesional M1 will be measured using paired pulse TMS at an interstimulus interval (ISI) of 2 milliseconds (ms). Cortical stimulation intensity was delivered at 60% and 80% of the motor threshold (MT). SICI is expressed as the ratio between the mean MEP amplitude in response to a single TMS and the mean MEP amplitude in response to a paired pulse TMS. A ratio of 1 means no inhibition, a ratio smaller than 1 means inhibition, and a ratio greater than 1 means facilitation.
Outcome measures
| Measure |
Stroke Patients
n=31 Participants
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
n=12 Participants
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
Sham Cortex Stimulation 60% MT, Pre - subacute stroke, or healthy control visit
|
0.92 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.70
|
1.00 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.56
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
Sham Cortex Stimulation 60% MT, Post - subacute stroke, or healthy control visit
|
0.76 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.57
|
0.73 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.32
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
Sham Cortex Stimulation 80% MT, Pre - subacute stroke, or healthy control visit
|
0.93 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.53
|
0.73 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.68
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
Sham Cortex Stimulation 80% MT, Post - subacute stroke, or healthy control visit
|
0.79 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.36
|
0.56 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.35
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
rTMS Cortex Stimulation 60% MT, Pre - subacute stroke, or healthy control visit
|
0.84 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.65
|
0.98 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.64
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
rTMS Cortex Stimulation 60% MT, Post - subacute stroke, or healthy control visit
|
0.92 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.52
|
0.99 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.42
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
rTMS Cortex Stimulation (CS) 80% MT, Pre - subacute stroke, or healthy control visit
|
1.00 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.55
|
0.88 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.82
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
rTMS Cortex Stimulation (CS) 80%, Post - subacute stroke, or healthy control visit
|
0.84 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.58
|
0.77 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.52
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
Sham Cortex Stimulation 60% MT, Pre - chronic stroke
|
0.95 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.68
|
—
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
Sham Cortex Stimulation 60% MT, Post - chronic stroke
|
0.89 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.43
|
—
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
Sham Cortex Stimulation 80% MT, Pre - chronic stroke
|
1.12 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.69
|
—
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
Sham Cortex Stimulation 80% MT, Post - chronic stroke
|
0.83 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.54
|
—
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
rTMS Cortex Stimulation 60% MT, Pre - chronic stroke
|
0.92 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.71
|
—
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
rTMS Cortex Stimulation 60% MT, Post - chronic stroke
|
0.89 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.99
|
—
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
rTMS Cortex Stimulation (CS) 80% MT, Pre - chronic stroke
|
0.99 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.46
|
—
|
|
Short Interval Cortical Inhibition (SICI) Measured by Repeated Transcranial Magnetic Stimulation (rTMS)
rTMS Cortex Stimulation (CS) 80%, Post - chronic stroke
|
1.09 ratio of MEP amplitude with TMS pulses
Standard Deviation 0.46
|
—
|
SECONDARY outcome
Timeframe: 1 month post-stroke (subacute stroke), 6 months post-stroke (chronic stroke)Population: This analysis includes participants with stroke who completed this assessment at the indicated study visit.
Stroke patients are asked to rapidly execute 7 ballistic wrist extension movements following an auditory cue. A 2-dimensional gyrometer is mounted on the dorsum of the hand to measure wrist extension movements. Electromyography (EMG) activity will be recorded on the extensor carpi ulnaris (ECU) muscle, a muscle that supports wrist extension movements.
Outcome measures
| Measure |
Stroke Patients
n=35 Participants
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
Peak Velocity During Wrist Extension Movement
Less affected side - subacute stroke - rTMS pre
|
700.54 radian per second (rad/sec)
Standard Deviation 248.34
|
—
|
|
Peak Velocity During Wrist Extension Movement
Less affected side - subacute stroke - rTMS post
|
686.24 radian per second (rad/sec)
Standard Deviation 305.79
|
—
|
|
Peak Velocity During Wrist Extension Movement
Less affected side - subacute stroke - sham pre
|
641.29 radian per second (rad/sec)
Standard Deviation 280.48
|
—
|
|
Peak Velocity During Wrist Extension Movement
Less affected side - subacute stroke - sham post
|
628.23 radian per second (rad/sec)
Standard Deviation 264.45
|
—
|
|
Peak Velocity During Wrist Extension Movement
More affected side - subacute stroke - rTMS pre
|
389.08 radian per second (rad/sec)
Standard Deviation 313.69
|
—
|
|
Peak Velocity During Wrist Extension Movement
More affected side - subacute stroke - rTMS post
|
373.75 radian per second (rad/sec)
Standard Deviation 294.01
|
—
|
|
Peak Velocity During Wrist Extension Movement
More affected side - subacute stroke - sham pre
|
413.10 radian per second (rad/sec)
Standard Deviation 317.41
|
—
|
|
Peak Velocity During Wrist Extension Movement
More affected side - subacute stroke - sham post
|
398.41 radian per second (rad/sec)
Standard Deviation 301.56
|
—
|
|
Peak Velocity During Wrist Extension Movement
Less affected side - chronic stroke - rTMS pre
|
659.25 radian per second (rad/sec)
Standard Deviation 266.67
|
—
|
|
Peak Velocity During Wrist Extension Movement
Less affected side - chronic stroke - rTMS post
|
630.80 radian per second (rad/sec)
Standard Deviation 276.10
|
—
|
|
Peak Velocity During Wrist Extension Movement
Less affected side - chronic stroke - sham pre
|
670.80 radian per second (rad/sec)
Standard Deviation 269.49
|
—
|
|
Peak Velocity During Wrist Extension Movement
Less affected side - chronic stroke - sham post
|
653.85 radian per second (rad/sec)
Standard Deviation 257.50
|
—
|
|
Peak Velocity During Wrist Extension Movement
More affected side - chronic stroke - rTMS pre
|
430.58 radian per second (rad/sec)
Standard Deviation 286.32
|
—
|
|
Peak Velocity During Wrist Extension Movement
More affected side - chronic stroke - rTMS post
|
415.61 radian per second (rad/sec)
Standard Deviation 290.76
|
—
|
|
Peak Velocity During Wrist Extension Movement
More affected side - chronic stroke - sham pre
|
444.48 radian per second (rad/sec)
Standard Deviation 288.84
|
—
|
|
Peak Velocity During Wrist Extension Movement
More affected side - chronic stroke - sham post
|
440.02 radian per second (rad/sec)
Standard Deviation 294.17
|
—
|
Adverse Events
Stroke Patients
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stroke Patients
n=42 participants at risk
Participants with stroke underwent assessment of their upper extremity and hand motor function, MRI of their brain, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS) at one month and six months post stroke.
|
Healthy Controls
n=31 participants at risk
Healthy control participants underwent MRI, single pulse transcranial magnetic stimulation (TMS), paired pulse transcranial stimulation (ppTMS), and low frequency repetitive transcranial magnetic stimulation (rTMS).
|
|---|---|---|
|
General disorders
Headache
|
11.9%
5/42 • Information on adverse events was collected beginning at the first study visit and continued through the final assessment, up to one year.
|
3.2%
1/31 • Information on adverse events was collected beginning at the first study visit and continued through the final assessment, up to one year.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
19.0%
8/42 • Information on adverse events was collected beginning at the first study visit and continued through the final assessment, up to one year.
|
0.00%
0/31 • Information on adverse events was collected beginning at the first study visit and continued through the final assessment, up to one year.
|
|
Psychiatric disorders
Panic attack in MR
|
2.4%
1/42 • Information on adverse events was collected beginning at the first study visit and continued through the final assessment, up to one year.
|
0.00%
0/31 • Information on adverse events was collected beginning at the first study visit and continued through the final assessment, up to one year.
|
|
Musculoskeletal and connective tissue disorders
Soreness in the wrist
|
2.4%
1/42 • Information on adverse events was collected beginning at the first study visit and continued through the final assessment, up to one year.
|
0.00%
0/31 • Information on adverse events was collected beginning at the first study visit and continued through the final assessment, up to one year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place