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Among the 795,000 individuals who sustain a stroke annually in the United States, 65% continue to experience moderate-to-severe impairments in one hand six months or more, which limits their ability to perform daily tasks. Currently there is dearth of understanding of the mechanisms of motor recovery after stroke. Understanding the mechanisms can potentially lead to the development of interventions to improve motor performance after stroke. The proposed study will examine how synchronously pairing brain and hand stimulation repeatedly affects the plasticity of the brain and motor performance after stroke. The knowledge gained from this study can be useful to develop interventions to improve hand movement after moderate-severe stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined non-invasive brain and Functional Electrical Stimulation | Experimental | In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Non-invasive brain stimulation and functional electrical hand stimulation | Device | Participants will receive synchronously combined non-invasive brain stimulation (delivered via electrical/magnetic stimulation) with functional electrical stimulation (delivered via DS7A or Neuromove) of the weak hand |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Box and Block Test | The Box and Block Test (BBT) measures unilateral gross manual dexterity and the ability to release objects. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the participants to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The box is oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. Participants first perform this test with their unaffected hand in order to practice and register baseline scores. Additionally, a 15-second trial period is permitted at the beginning of each side. Before the trial, after the standardized instructions are given to participants are advised that their fingertips must cross the partition when | Baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Motor Evoked Potential | Surface EMG electrodes (Ag-AgCl) will be applied to the belly of the affected EDC muscle and a reference electrode will be placed at the clavicle. The motor evoked potential (MEP) data will be collected by stimulating the targets in the grid at 2000 Hz with Signal software (CED, Cambridge, UK). The raw values are measured in mili volts, but we report as a percent change compared to the pre-intervention or baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amit Sethi | UPitt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuromotor Recovery and Rehabilitation Lab | Pittsburgh | Pennsylvania | 15260 | United States |
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We recruited 10 participants from 2020-2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Combined Non-invasive Brain and Functional Electrical Stimulation | In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combined Non-invasive Brain and Functional Electrical Stimulation | In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES |
| 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 | Percent Change in Box and Block Test | The Box and Block Test (BBT) measures unilateral gross manual dexterity and the ability to release objects. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the participants to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The box is oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. Participants first perform this test with their unaffected hand in order to practice and register baseline scores. Additionally, a 15-second trial period is permitted at the beginning of each side. Before the trial, after the standardized instructions are given to participants are advised that their fingertips must cross the partition when | Posted | Mean | Standard Deviation | percent change of number of blocks | Baseline to 6 weeks |
|
From enrollment until the end of 6 weeks
There were no serious adverse events or any other adverse events reported. There was no all-cause mortality reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combined Non-invasive Brain and Functional Electrical Stimulation | In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amit Sethi | University of Pittsburgh | 4123836619 | asethi@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 14, 2020 | Jul 14, 2025 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Baseline to 6 weeks |
| Average Percent Change in Hand Force | We will measure force production of the combined wrist and finger extensors (EDC) using two 34.09 kg load cells embedded in cushioned customized platforms. The height of the load cells can be altered to accommodate individual hand sizes. Participants will perform 5 trials of combined isometric wrist and finger extension movements against load cells for 10 seconds. The force data will be amplified by 5-20K and collected at 1000 Hz using Biopac amplifier and software (Biopac Systems Inc, Goleta, CA, USA). To allow for the deliberate increase to peak force as well as the tendency to drop off near the end of the 10-second interval, we will calculate the combined wrist and finger extension force output over the central 5 second segment. We will average the force across 5 trials. The raw values are measured in kilograms force, but we report as an average percent change compared to the pre-intervention or baseline. | Baseline to 6 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Upper Limb Fugl-Meyer Score | This scale measures the motor control of the weak upper extremity after stroke. The minimum score is 0 and the maximum score is 66, where higher scores are considered as better motor control. | Mean | Standard Deviation | score on a scale |
|
| OG000 |
| Combined Non-invasive Brain and Functional Electrical Stimulation |
In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES |
|
|
|
| Secondary | Percent Change in Motor Evoked Potential | Surface EMG electrodes (Ag-AgCl) will be applied to the belly of the affected EDC muscle and a reference electrode will be placed at the clavicle. The motor evoked potential (MEP) data will be collected by stimulating the targets in the grid at 2000 Hz with Signal software (CED, Cambridge, UK). The raw values are measured in mili volts, but we report as a percent change compared to the pre-intervention or baseline. | Posted | Mean | Standard Deviation | percent change of motor evoked potential | Baseline to 6 weeks |
|
|
|
|
| Secondary | Average Percent Change in Hand Force | We will measure force production of the combined wrist and finger extensors (EDC) using two 34.09 kg load cells embedded in cushioned customized platforms. The height of the load cells can be altered to accommodate individual hand sizes. Participants will perform 5 trials of combined isometric wrist and finger extension movements against load cells for 10 seconds. The force data will be amplified by 5-20K and collected at 1000 Hz using Biopac amplifier and software (Biopac Systems Inc, Goleta, CA, USA). To allow for the deliberate increase to peak force as well as the tendency to drop off near the end of the 10-second interval, we will calculate the combined wrist and finger extension force output over the central 5 second segment. We will average the force across 5 trials. The raw values are measured in kilograms force, but we report as an average percent change compared to the pre-intervention or baseline. | Posted | Mean | Standard Deviation | percent change of force | Baseline to 6 weeks |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |