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| ID | Type | Description | Link |
|---|---|---|---|
| CWRU-FDR001244 | Other Grant/Funding Number | US FDA Offoce of Orphan product Development |
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OBJECTIVES:
I. Establish the procedures for implementing and assessing the clinical utility of functional neuromuscular stimulation using an implanted eight-channel standing and transfer system in patients with incomplete tetraplegia or paraplegia.
II. Develop and apply quantitative functional evaluations of system performance in these patients.
III. Perform long term follow up and monitor system use outside of the laboratory.
PROTOCOL OUTLINE: Patients undergo surgery in which electrodes are sutured into areas of the pelvis and legs. Electrode leads are inserted into a receiver/stimulator implanted in a subcutaneous pocket in the abdomen. Following implantation, patients undergo training in standing, transfers, and other advanced mobility skills using the functional neuromuscular stimulation system. Restricted activity continues for 2 weeks after surgery, followed by 8 weeks of exercise. Standing training then begins, and continues for up to 6 weeks. Home-based training follows prior to discharge with the system for spontaneous use.
Patients are followed at 3, 6, and 12 months, then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implanted Neuroprosthesis | Experimental | Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures. Interventions include: Procedure/Surgery Rehabilitation/Exercise Device includes: IRS-8 Stimulating Electrodes External Controller |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure |
| ||
| IRS-8 |
| Measure | Description | Time Frame |
|---|---|---|
| Standing Performance | A measure of how long an individual can maintain a standing position. | Discharge, 1 follow-up between 6-12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of Body Weight Through the Legs and Arms While Standing | Measure of how much weight is placed on the legs and arms while standing | Discharge, 1 follow-up between 6-12 months |
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Inclusion Criteria:
Low cervical or thoracic spinal cord injuries (C6-T12) Must be skeletally mature ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing), or C (motor and sensory sparing) Intact lower motor neurons Greater than 6 months since injury Range of motion within normal limits No renal compromise No cardiac abnormalities No circulatory compromise No pulmonary compromise No acute or chronic psychological problems or chemical dependency No acute orthopedic complications (scoliosis, history of spontaneous fractures, dislocations, etc.) No acute medical complications (no skin breakdowns, uncontrolled seizures, immunological compromise, etc.)
Exclusion Criteria:
Failure to meet inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ronald J. Triolo | Case Western Reserve University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States | ||
| MetroHealth System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28899825 | Derived | Triolo RJ, Bailey SN, Foglyano KM, Kobetic R, Lombardo LM, Miller ME, Pinault G. Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up. Arch Phys Med Rehabil. 2018 Feb;99(2):289-298. doi: 10.1016/j.apmr.2017.08.470. Epub 2017 Sep 9. | |
| 22773528 | Derived |
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Participants will go through a screening process that will determine eligibility for the study. If they don't meet the inclusion or exclusion criteria they will not be invited to continue to the second phase of the study.
Recruitment of participants is based on evaluation of past medical history and in person evaluation including strength, ROM, and response to stimulation to determine eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Implanted Neuroprosthesis | Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in [ost-operative training and follow-up procedures. Surgery IRS-8](streamdown:incomplete-link) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Implanted Neuroprosthesis | Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in [ost-operative training and follow-up procedures. Surgery IRS-8](streamdown:incomplete-link) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Standing Performance | A measure of how long an individual can maintain a standing position. | Posted | Mean | Standard Deviation | minutes | Discharge, 1 follow-up between 6-12 months follow-up |
|
|
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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 Neuroprosthesis | Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in [ost-operative training and follow-up procedures. Surgery IRS-8](streamdown:incomplete-link) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Lombardo, MPT | Louis Stokes Cleveland VAMC | 216-791-3800 | 4909 | lisa.lombardo2@va.gov |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009461 | Neurologic Manifestations |
| D001523 | Mental Disorders |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
| Cleveland |
| Ohio |
| 44109 |
| United States |
| Rohde LM, Bonder BR, Triolo RJ. Exploratory study of perceived quality of life with implanted standing neuroprostheses. J Rehabil Res Dev. 2012;49(2):265-78. doi: 10.1682/jrrd.2010.08.0156. |
| 22541312 | Derived | Triolo RJ, Bailey SN, Miller ME, Rohde LM, Anderson JS, Davis JA Jr, Abbas JJ, DiPonio LA, Forrest GP, Gater DR Jr, Yang LJ. Longitudinal performance of a surgically implanted neuroprosthesis for lower-extremity exercise, standing, and transfers after spinal cord injury. Arch Phys Med Rehabil. 2012 May;93(5):896-904. doi: 10.1016/j.apmr.2012.01.001. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Distribution of Body Weight Through the Legs and Arms While Standing | Measure of how much weight is placed on the legs and arms while standing | Posted | Mean | Standard Deviation | percentage of body weight | Discharge, 1 follow-up between 6-12 months |
|
|
|
| 1 |
| 15 |
| 0 |
| 15 |
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| D014947 | Wounds and Injuries |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |