Pilot Trial of a System for Motor Function Recovery

Niche Biomedical (ANEUVO)

Status: Completed

Conditions: Spinal Cord Diseases

Treatments: Device: Stimulator; Device: Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT04683471

EXA-2001

Details and patient eligibility

About

This is a multi-center, prospective, blinded, pilot feasibility study to evaluate improvement in sensory and motor function with sham.

Enrollment: 12 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Neuromodulation

Experimental group

Description:

Neuromodulation

Treatment:

Device: Stimulator

Sham

Sham Comparator group

Description:

Sham

Treatment:

Device: Sham