Pilot Feasibility Clinical Validation Study

Niche Biomedical, Inc. dba ANEUVO3 sites in 1 country12 target enrollmentNovember 30, 2020

ConditionsSpinal Cord Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinal Cord Diseases
Sponsor: Niche Biomedical, Inc. dba ANEUVO
Enrollment: 12
Locations: 3
Primary Endpoint: Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 30, 2020

End Date

March 22, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Niche Biomedical, Inc. dba ANEUVO

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

Time Frame: 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