Pilot Trial of a System for Motor Function Recovery

Not Applicable

Completed

• Conditions: Spinal Cord Diseases
• Interventions: Device: Stimulator; Device: Sham

• Registration Number: NCT04683471
• Lead Sponsor: Niche Biomedical, Inc. dba ANEUVO

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-30
• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-21
• Study First Posted: 2020-12-24
• Primary Completion: 2021-12-22
• Study Completion: 2022-03-22
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Neuromodulation	Stimulator	Neuromodulation
Sham	Sham	Sham

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States

Houston Methodist Research Institute; 🇺🇸 Houston, Texas, United States

Kennedy Krieger Institute; 🇺🇸 Baltimore, Maryland, United States