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| ID | Type | Description | Link |
|---|---|---|---|
| VA Merit Review A3707R | Other Grant/Funding Number | Dept. Veterans Affairs |
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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
| VA Office of Research and Development | FED |
| FDA Office of Orphan Products Development | FED |
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The purpose of this study is to evaluate the effectiveness of an implanted stimulator and sensor for providing hand and arm function for individuals with cervical level spinal cord injury.
The design of this study is to determine the efficacy of improving upper extremity function in tetraplegic subjects after receiving an implantable device for neuromuscular control. Evaluations will be made so as to document changes in performance of manipulative tasks when using the stimulation system.
Subjects who consent to participate in this project will have an implantable stimulator surgically placed in the upper extremity for control of the upper extremity. A series of tests will be performed before implantation, and repeated at intervals after implantation to assess changes in each subject's performance.
This study is a non-randomized feasibility study with concurrent (neuroprosthesis on and off) and longitudinal (pre- and post-implantation/training) self-controls.
Subjects participating in the study can expect to be actively involved in the study for two years after implantation and followed for life thereafter. The screening procedures take up to two days, depending on the specific evaluations necessary to determine candidacy. Pre-surgical exercise is conducted for at least two weeks. The implantation surgery itself lasts one day, with three to seven days of post-surgical hospitalization. Following an eight-week exercise program and a twelve-week training program, subjects are discharged from the active rehabilitation phase. They are followed quarterly for one year, and then annually thereafter.
The device is referred to as the Implanted Stimulator-Telemeter (IST) -12. The device uses functional electrical stimulation (FES) to activate paralyzed muscles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation ON | Experimental | Individuals implanted with stimulator/sensor device. Stimulator is turned on and is active. |
|
| Stimulation OFF | Active Comparator | Function with stimulation turned off. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IST-12 | Device | Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grasp-Release Test | Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) [Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers [Peckham, 2001]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (~1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds. | One Year |
| Activities of Daily Living Test | The ADL Abilities Test was developed to measure differences in activity performance with and without a hand neuroprosthesis. Scoring is based on an activity analysis approach. The activities, which are chosen by the participant, are broken down into phases, and each phase is scored for the amount of assistance the participant uses: 1) "Physical Assistance" (PA): assistance from an attendant, 2) "Adaptive Equipment" (AE): any modifications of the activity or its components, 3) "Orthotic Assistance" (OA): an orthotic device that the participant normally wears all day (e.g., a dorsal wrist support), and that can be considered a modification of the hand, 4) "Self Assistance" (SA): use of any part of the body other than the dominant hand, or use of the test equipment in an adapted way to complete the activity (e.g., using two hands to hold a glass, or sliding an object to the end of the table for grasping), and 5) "Independent". | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Self-reported adverse events. | From date of implant until study completion or date of death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin L Kilgore, Ph.D. | MetroHealth Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11901386 | Background | Peckham PH, Kilgore KL, Keith MW, Bryden AM, Bhadra N, Montague FW. An advanced neuroprosthesis for restoration of hand and upper arm control using an implantable controller. J Hand Surg Am. 2002 Mar;27(2):265-76. doi: 10.1053/jhsu.2002.30919. | |
| 29997428 | Background | Kilgore KL, Bryden A, Keith MW, Hoyen HA, Hart RL, Nemunaitis GA, Peckham PH. Evolution of Neuroprosthetic Approaches to Restoration of Upper Extremity Function in Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2018 Summer;24(3):252-264. doi: 10.1310/sci2403-252. |
| Label | URL |
|---|---|
| Cleveland FES Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Implanted Individuals | Individuals implanted with stimulator/sensor device. These individuals were implanted with the IST-12 device. The IST-12 is an implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes. The device was implanted in the chest, hand and arm to provide functional grasp and reach. All participants received the implanted device. During the primary outcome testing, the device was tested with the device "on" and active and compared with the results when the device was turned off. No blinding of either the subject or evaluator was possible because of the obvious response when the stimulator is on (i.e. the hand opens and closes when the stimulator is on; the hand is paralyzed when the stimulator is off). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Implanted Individuals | Individuals implanted with stimulator/sensor device. IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Grasp-Release Test | Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) [Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers [Peckham, 2001]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (~1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds. | Posted | Median | Full Range | Number of Objects | One Year |
|
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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 | Implanted Individuals | Individuals implanted with stimulator/sensor device. IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes. Note that all subjects received the implanted device and used the device in the laboratory and at home throughout the course of the study. Therefore there is only a single Arm for adverse events - all subjects received the intervention and stimulation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device infection | Infections and infestations | Non-systematic Assessment | Device infection requiring removal of some or all of implanted components. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | MetroHealth Medical Center | 2169573683 | ue.fes.clinicaltrials@gmail.com |
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| 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 |
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| 11588741 | Result | Peckham PH, Keith MW, Kilgore KL, Grill JH, Wuolle KS, Thrope GB, Gorman P, Hobby J, Mulcahey MJ, Carroll S, Hentz VR, Wiegner A; Implantable Neuroprosthesis Research Group. Efficacy of an implanted neuroprosthesis for restoring hand grasp in tetraplegia: a multicenter study. Arch Phys Med Rehabil. 2001 Oct;82(10):1380-8. doi: 10.1053/apmr.2001.25910. |
| 18406958 | Result | Kilgore KL, Hoyen HA, Bryden AM, Hart RL, Keith MW, Peckham PH. An implanted upper-extremity neuroprosthesis using myoelectric control. J Hand Surg Am. 2008 Apr;33(4):539-50. doi: 10.1016/j.jhsa.2008.01.007. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Grasp-Release Test - Baseline | The Grasp-Release tests consists of six standard objects requiring different grasp patterns and forces to pick up and move. The subjects have a fixed period of time to attempt to acquire the object and move it from one location on the test board to a second location. The outcome is measured as the number of objects that they can successfully pick up and move. The minimum score is 0 and the maximum score is 6. | Median | Full Range | Objects |
|
Individuals implanted with stimulator/sensor device. Stimulator is turned on and is active.
IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.
| OG001 | Stimulation OFF | Function with stimulation turned off. IST-12: Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes. |
|
|
| Primary | Activities of Daily Living Test | The ADL Abilities Test was developed to measure differences in activity performance with and without a hand neuroprosthesis. Scoring is based on an activity analysis approach. The activities, which are chosen by the participant, are broken down into phases, and each phase is scored for the amount of assistance the participant uses: 1) "Physical Assistance" (PA): assistance from an attendant, 2) "Adaptive Equipment" (AE): any modifications of the activity or its components, 3) "Orthotic Assistance" (OA): an orthotic device that the participant normally wears all day (e.g., a dorsal wrist support), and that can be considered a modification of the hand, 4) "Self Assistance" (SA): use of any part of the body other than the dominant hand, or use of the test equipment in an adapted way to complete the activity (e.g., using two hands to hold a glass, or sliding an object to the end of the table for grasping), and 5) "Independent". | Posted | Median | Full Range | Number of Tasks Improved | Three months |
|
|
|
| Secondary | Adverse Events | Self-reported adverse events. | Not Posted | From date of implant until study completion or date of death from any cause. | Participants |
| 0 |
| 10 |
| 2 |
| 10 |
|
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| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |