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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
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This study is for people who have a paralyzed arm and hand from a spinal cord injury, who have also received a recording electrode array in the brain as part of the BrainGate study. The study will look at the ability of these participants to control different grasping patterns of the hand, both in virtual reality and in his/her actual hand. Movement of the participant's hand is controlled by a functional electrical stimulation (FES) system, which involves small electrodes implanted in the arm, shoulder and hand that use small electrical currents to activate the appropriate muscles.
This work aims to advance Brain-Computer-Interfaces (BCls) to provide severely paralyzed persons a natural way of controlling Functional Electrical Stimulation (FES) neuroprostheses for restoring arm and dexterous hand movements. The prospect of using BCI technology for restoring arm and hand movements for reaching and grasping is based on the hypothesis that in a paralyzed human, there is a repeatable and understandable relationship between recordable brain activity and specific aspects of imagined arm movements. Many previous studies have attempted to understand the relationships between brain activity and arm and hand movements in able-bodied monkeys. Little is known about these same relationships in humans, and specifically within the context of trying to control an FES arm and complex hand system. This study will recruit persons who already have BCI and FES systems implanted to take advantage of the possibility of recording high resolution brain activity in human participants. Thus, from this study, we aim to gain a better understanding of how brain signals are related to specific aspects of arm and complex hand movements in humans with paralysis. Additionally, this study will test novel implementations of complex hand movement restoration in Veterans and other persons with chronic hand and arm paralysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cortical Control of Grasp Patterns | Experimental | Participants will be asked to think about holding different shaped objects, and the recorded cortical signal patterns will be decoded to match those grasp shapes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Using the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system | Device | Participants will be asked to think about holding different shaped objects, and the recorded cortical signal patterns will be decoded to match those grasp shapes |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to Form Appropriate Grasp Patterns | The success rate for achieving a series of specified grasp patterns will be calculated. This will be a percentage of the target grasp patterns successfully achieved. The reported outcome is an average of the outcomes (mean +/- standard deviation) over the full assessment period | Outcomes were assessed on average every 3 months for the full time (4 years) that the participant was enrolled in the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abidemi B. Ajiboye, PhD | Louis Stokes VA Medical Center, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106-1702 | United States |
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| Label | URL |
|---|---|
| Home site of BrainGate clinical trial | View source |
| Home site of ReHAB study | View source |
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We will not be sharing individual participant data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cortical Control of Grasp Patterns | Participants will be asked to think about holding different shaped objects, and the recorded cortical signal patterns will be decoded to match those grasp shapes Using the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system: Participants will be asked to think about holding different shaped objects, and the recorded cortical signal patterns will be decoded to match those grasp shapes |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Mar 23, 2018 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cortical Control of Grasp Patterns | Participants will be asked to think about holding different shaped objects, and the recorded cortical signal patterns will be decoded to match those grasp shapes Using the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system: Participants will be asked to think about holding different shaped objects, and the recorded cortical signal patterns will be decoded to match those grasp shapes |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Ability to Form Appropriate Grasp Patterns | The success rate for achieving a series of specified grasp patterns will be calculated. This will be a percentage of the target grasp patterns successfully achieved. The reported outcome is an average of the outcomes (mean +/- standard deviation) over the full assessment period | Posted | Mean | Standard Deviation | percentage of correct grasps formed | Outcomes were assessed on average every 3 months for the full time (4 years) that the participant was enrolled in the study. |
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from enrollment until end of study, up to 48 months
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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 | Cortical Control of Grasp Patterns | Participants will be asked to think about holding different shaped objects, and the recorded cortical signal patterns will be decoded to match those grasp shapes Using the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system: Participants will be asked to think about holding different shaped objects, and the recorded cortical signal patterns will be decoded to match those grasp shapes | 0 | 1 | 0 | 1 | 0 | 1 |
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The trial enrolled one study participant, and hence the while the results demonstrate the possible benefit of the intervention, they do not necessarily represent an average expected benefit for any one individual.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Abidemi Bolu Ajiboye | Louis Stokes Cleveland VA Medical Center | 2167913800 | 64657 | abidemi.ajiboye@va.gov |
| Nov 26, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2018 | Nov 26, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D011782 | Quadriplegia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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