Spinal Cord Injury
Conditions
Keywords
environmental/toxic disorders, neurologic and psychiatric disorders, rare disease, spinal cord injury
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESurgery
DEVICEIRS-8
Sponsors
Case Western Reserve University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standing Performance | Discharge, 1 follow-up between 6-12 months follow-up | A measure of how long an individual can maintain a standing position. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Body Weight Through the Legs and Arms While Standing | Discharge, 1 follow-up between 6-12 months | Measure of how much weight is placed on the legs and arms while standing |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Implanted Neuroprosthesis |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 33.7 years STANDARD_DEVIATION 7.3 |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 1 / 15 |
Outcome results
Primary
Standing Performance
A measure of how long an individual can maintain a standing position.
Time frame: Discharge, 1 follow-up between 6-12 months follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implanted Neuroprosthesis | Standing Performance | Discharge standing time | 27.4 minutes | Standard Deviation 38.6 |
| Implanted Neuroprosthesis | Standing Performance | 6-12 month follow-up standing time | 15.6 minutes | Standard Deviation 21.8 |
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
Time frame: Discharge, 1 follow-up between 6-12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implanted Neuroprosthesis | Distribution of Body Weight Through the Legs and Arms While Standing | Discharge body weight distribution | 90.0 percentage of body weight | Standard Deviation 13.1 |
| Implanted Neuroprosthesis | Distribution of Body Weight Through the Legs and Arms While Standing | 6-12 month follow-up body weight distribution | 76.7 percentage of body weight | Standard Deviation 22.2 |