Spinal Cord Diseases Clinical Trial
Official title:
Pilot Feasibility Clinical Validation Study
Verified date | April 2022 |
Source | Niche Biomedical Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multi-center, prospective, blinded, pilot feasibility study to evaluate improvement in sensory and motor function with sham.
Status | Completed |
Enrollment | 12 |
Est. completion date | March 22, 2022 |
Est. primary completion date | December 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: - Traumatic chronic spinal cord injury Exclusion Criteria: - Active implanted medical device - Internal metallic objects of unknown or foreign origin - Implanted anti-spasticity pumps, Botox injections in prior 3 months or other current anti-spasticity regimen - BMI > 40.0 - Acute medical conditions under active treatment that would contraindicate standard rehabilitation including open wounds - Pregnancy or planned pregnancy - Unhealed bone fractures, peripheral neuropathies or painful musculoskeletal dysfunction - Cardiopulmonary disease or ventilator dependency - Uncontrolled epilepsy or seizures - Clinically significant depression, psychiatric disorders or ongoing substance abuse |
Country | Name | City | State |
---|---|---|---|
United States | Kennedy Krieger Institute | Baltimore | Maryland |
United States | Shirley Ryan AbilityLab | Chicago | Illinois |
United States | Houston Methodist Research Institute | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Niche Biomedical Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) for the upper limbs
Scoring: Strength scored 0 - 50 for each arm Sensibility scored 0 - 24 for each arm Prehension scored 0 - 42 for each arm Higher scores are a better outcome |
Biweekly through study completion up to 18 weeks |
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