Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CBET-1264562 | Other Grant/Funding Number | National Science Foundation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether the combination of low frequency repetitive transcranial magnetic stimulation (rTMS) and motor-imagery-based brain computer interface (BCI) training is effective for enhancing motor recovery after stroke.
The PI's hypothesis is that, in comparison with traditional physical therapy alone, subjects receiving supplementary rTMS and BCI training will show greater functional improvements in hand motor ability over time as well as recovery of normal motor connectivity patterns.
The goal of the present study is to develop and evaluate a brain based approach to improve motor recovery after stroke, by combining rTMS and BCI training. Treatments will consist of low frequency rTMS applied to the contralesional hemisphere, followed by BCI training to encourage activity within the lesioned hemisphere. The primary objective of this study is to test the main hypothesis above in a stroke patient population. Subjects will also undergo a period of BCI only treatments after completion of the combined rTMS and BCI portion.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Subjects receiving standard-of-care physical therapy only. | |
| Sham rTMS + Real BCI Training | Sham Comparator | Subjects will receive sham rTMS followed by real BCI training. |
|
| Real rTMS + Real BCI Training | Active Comparator | Subjects will receive real rTMS followed by real BCI training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS | Device | Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI | 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. | Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Hand Motor Function as Measured by the Box and Block Test | 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. | Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Report of Symptoms | The subject report of symptoms assesses whether subject experience any adverse effects as a result of participation in the study. | within 12 weeks of participation |
| Changes in the Resting Motor Threshold |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bin He, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical and Translational Science Institute | Minneapolis | Minnesota | 55455 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | Subjects receiving standard-of-care physical therapy only. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No subjects were enrolled in the control (no real or sham rTMS) group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Subjects receiving standard-of-care physical therapy only. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI | 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. | The laterality index was not calculated for one subject in post-test 2 as no activation overlapped with the ipsilesional or contralesional precentral gyrus. | Posted | Mean | Full Range | Laterality index | Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Subjects receiving standard-of-care physical therapy only. | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bin He | University of Minnesota | 612-626-1115 | binhe@umn.edu |
Not provided
| ID | Term |
|---|---|
| D010291 | Paresis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BCI Training | Behavioral | 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 |
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. |
| Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks) |
| Changes in Inter-hemispheric Inhibition | 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). | 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.
| Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks) |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | Changes in Hand Motor Function as Measured by the Box and Block Test | 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. | Posted | Mean | Full Range | Number of blocks | Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks) |
|
|
|
| Secondary | Changes in Paretic Hand Motor Function as Measured by the Finger Tracking Test | 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. | Posted | Mean | Full Range | Accuracy index | Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks) |
|
|
|
| Secondary | Changes in Inter-hemispheric Inhibition | 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). | Posted | Mean | Full Range | PP/SP ratio | Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks) |
|
|
|
| Other Pre-specified | Subject Report of Symptoms | The subject report of symptoms assesses whether subject experience any adverse effects as a result of participation in the study. | Not Posted | within 12 weeks of participation | Participants |
| Other Pre-specified | Changes in the Resting Motor Threshold | The resting motor threshold is a measure of cortical excitability, and will be recorded for both the stroke and non-stroke hemispheres. | Not Posted | Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks) | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
Not provided
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Post-test 2 |
|
| Post-test 2 |
|
| Post-test 1, ipsi-to-contralesional |
|
| Post-test 1, contra-to-ipsilesional |
|