Trial Outcomes & Findings for A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training (NCT NCT02132520)
NCT ID: NCT02132520
Last Updated: 2019-11-01
Results Overview
The MRI and functional MRI will evaluate the extent to which cortical areas are recruited both during rest and during movement related tasks. This is quantified by a laterality index, calculated as the ratio of activations of ipsi- and contra-lesional precentral gyri during a paretic hand tracking task. A LI of -1 corresponds to entirely contralesional activation, while a value of +1 corresponds to entirely ipsilesional activation.
COMPLETED
NA
3 participants
Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
2019-11-01
Participant Flow
Participant milestones
| Measure |
Control
Subjects receiving standard-of-care physical therapy only.
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Sham rTMS + Real BCI Training
Subjects will receive sham rTMS followed by real BCI training.
rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
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Real rTMS + Real BCI Training
Subjects will receive real rTMS followed by real BCI training.
rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
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Overall Study
STARTED
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0
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1
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2
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Overall Study
COMPLETED
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0
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1
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2
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Overall Study
NOT COMPLETED
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training
Baseline characteristics by cohort
| Measure |
Control
Subjects receiving standard-of-care physical therapy only.
|
Sham rTMS + Real BCI Training
n=1 Participants
Subjects will receive sham rTMS followed by real BCI training.
rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
|
Real rTMS + Real BCI Training
n=2 Participants
Subjects will receive real rTMS followed by real BCI training.
rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
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Total
n=3 Participants
Total of all reporting groups
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|---|---|---|---|---|
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Age, Continuous
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—
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37 years
n=7 Participants
|
64.5 years
n=5 Participants
|
55.3 years
n=4 Participants
|
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Sex: Female, Male
Female
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—
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1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
—
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
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Region of Enrollment
United States
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—
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1 participants
n=7 Participants
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2 participants
n=5 Participants
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3 participants
n=4 Participants
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PRIMARY outcome
Timeframe: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)Population: The laterality index was not calculated for one subject in post-test 2 as no activation overlapped with the ipsilesional or contralesional precentral gyrus.
The MRI and functional MRI will evaluate the extent to which cortical areas are recruited both during rest and during movement related tasks. This is quantified by a laterality index, calculated as the ratio of activations of ipsi- and contra-lesional precentral gyri during a paretic hand tracking task. A LI of -1 corresponds to entirely contralesional activation, while a value of +1 corresponds to entirely ipsilesional activation.
Outcome measures
| Measure |
Sham rTMS + Real BCI Training
n=1 Participants
Subjects will receive sham rTMS followed by real BCI training.
rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
|
Real rTMS + Real BCI Training
n=2 Participants
Subjects will receive real rTMS followed by real BCI training.
rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
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|---|---|---|
|
Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI
Baseline
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0.71 Laterality index
Interval 0.71 to 0.71
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0.72 Laterality index
Interval 0.44 to 1.0
|
|
Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI
Post-test 1
|
-0.25 Laterality index
Interval -0.25 to -0.25
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0.81 Laterality index
Interval 0.61 to 1.0
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Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI
Post-test 2
|
1 Laterality index
Interval 1.0 to 1.0
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0.80 Laterality index
Interval 0.8 to 0.8
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SECONDARY outcome
Timeframe: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)Performance on the box and block test with the paretic hand, quantified as the number of 2.5 cm\^3 cubes grasped, lifted, and released to transfer between compartments correctly within 60 seconds.
Outcome measures
| Measure |
Sham rTMS + Real BCI Training
n=1 Participants
Subjects will receive sham rTMS followed by real BCI training.
rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
|
Real rTMS + Real BCI Training
n=2 Participants
Subjects will receive real rTMS followed by real BCI training.
rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
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|---|---|---|
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Changes in Hand Motor Function as Measured by the Box and Block Test
Post-test 1
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32.3 Number of blocks
Interval 32.3 to 32.3
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1.66 Number of blocks
Interval 1.0 to 2.33
|
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Changes in Hand Motor Function as Measured by the Box and Block Test
Post-test 2
|
39.4 Number of blocks
Interval 39.4 to 39.4
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2.84 Number of blocks
Interval 1.33 to 4.34
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Changes in Hand Motor Function as Measured by the Box and Block Test
Baseline
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26.0 Number of blocks
Interval 26.0 to 26.0
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2.67 Number of blocks
Interval 0.33 to 5.01
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SECONDARY outcome
Timeframe: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)The finger tracking test evaluates the subject's ability to track an oscillating wave with either their paretic or non-paretic finger. Subjects wore custom electro-goniometer braces on each hand, each of which included a potentiometer signaling extension and flexion of the index finger metacarpophalangeal joint. Subjects were presented with target stimuli with a random sinusoidal waveform and were instructed to move the corresponding index finger to match the target trace as the cursor moved across the screen with constant velocity. Performance was quantified by an accuracy index, calculated using the ratio of the error to the standard deviation of the target, normalized to the range of motion for each subject.
Outcome measures
| Measure |
Sham rTMS + Real BCI Training
n=1 Participants
Subjects will receive sham rTMS followed by real BCI training.
rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
|
Real rTMS + Real BCI Training
n=2 Participants
Subjects will receive real rTMS followed by real BCI training.
rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
|
|---|---|---|
|
Changes in Paretic Hand Motor Function as Measured by the Finger Tracking Test
Baseline
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0.005 Accuracy index
Interval 0.005 to 0.005
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-0.028 Accuracy index
Interval -0.03 to -0.025
|
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Changes in Paretic Hand Motor Function as Measured by the Finger Tracking Test
Post-test 1
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0.008 Accuracy index
Interval 0.008 to 0.008
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-0.011 Accuracy index
Interval -0.018 to -0.004
|
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Changes in Paretic Hand Motor Function as Measured by the Finger Tracking Test
Post-test 2
|
0.009 Accuracy index
Interval 0.009 to 0.009
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-0.008 Accuracy index
Interval -0.015 to -0.001
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SECONDARY outcome
Timeframe: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)Inter-hemispheric Inhibition was evaluated using paired-pulse TMS both for the stroke hemisphere to non-stroke hemisphere direction as well as for the non-stroke hemisphere to the stroke hemisphere direction. IHI was measured by applying TMS to identified left and right motor hotspots at 1 mV threshold intensity, or 130% of the RMT if 1 mV threshold could not be identified, with single unilateral pulses and paired bilateral pulses. IHI was quantified by comparing the paired-pulse peak-to-peak motor evoked potential amplitudes to the corresponding single pulse MEP amplitudes for each direction of stimulation (ipsi- to contra-lesional and contra- to ipsi-lesional).
Outcome measures
| Measure |
Sham rTMS + Real BCI Training
n=1 Participants
Subjects will receive sham rTMS followed by real BCI training.
rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
|
Real rTMS + Real BCI Training
n=2 Participants
Subjects will receive real rTMS followed by real BCI training.
rTMS: Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
BCI Training: BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
|
|---|---|---|
|
Changes in Inter-hemispheric Inhibition
Baseline, contra-to-ipsilesional
|
1.26 PP/SP ratio
Interval 1.26 to 1.26
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0.42 PP/SP ratio
Interval 0.34 to 0.49
|
|
Changes in Inter-hemispheric Inhibition
Post-test 1, ipsi-to-contralesional
|
0.90 PP/SP ratio
Interval 0.9 to 0.9
|
1.41 PP/SP ratio
Interval 0.86 to 1.97
|
|
Changes in Inter-hemispheric Inhibition
Post-test 1, contra-to-ipsilesional
|
0.31 PP/SP ratio
Interval 0.31 to 0.31
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1.62 PP/SP ratio
Interval 1.1 to 2.15
|
|
Changes in Inter-hemispheric Inhibition
Baseline, ipsi-to-contralesional
|
1.28 PP/SP ratio
Interval 1.28 to 1.28
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0.64 PP/SP ratio
Interval 0.62 to 0.65
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OTHER_PRE_SPECIFIED outcome
Timeframe: within 12 weeks of participationThe subject report of symptoms assesses whether subject experience any adverse effects as a result of participation in the study.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)The resting motor threshold is a measure of cortical excitability, and will be recorded for both the stroke and non-stroke hemispheres.
Outcome measures
Outcome data not reported
Adverse Events
Control
Sham rTMS + Real BCI Training
Real rTMS + Real BCI Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place