Spinal Cord Diseases
Conditions
Brief summary
This is a multi-center, prospective, blinded, pilot feasibility study to evaluate improvement in sensory and motor function with sham.
Interventions
DEVICEStimulator
Neuromodulation
DEVICESham
Sham
Sponsors
Niche Biomedical, Inc. dba ANEUVO
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | Biweekly through study completion up to 18 weeks | 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 |
Countries
United States
Outcome results
None listed