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ACTIVE NOT RECRUITING
NCT06850363
NA

ExaStim Upper Limb Home Use Clinical Validation Study

Sponsor: Niche Biomedical, Inc. dba ANEUVO

View on ClinicalTrials.gov

Summary

This is a multi-center, observational, single-arm, 6-week home study to evaluate the safety and efficacy of transcutaneous spinal cord stimulation via the ExaStim system for 4 consecutive weeks used in the home setting for individuals with traumatic spinal cord injury. The study consists of a baseline evaluation and 1-week training period (Week 0), a 4-week stimulation period (Weeks 1-4), and a follow-up visit (Week 5), for a total expected duration of participation for each subject of six weeks.

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-03-17

Completion Date

2026-04-30

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DEVICE

ExaStim Stimulation System

Transcutaneous Spinal Cord Stimulation

Locations (5)

Craig Rehabilitation Hospital

Denver, Colorado, United States

TryAbility Neurorecovery Center

Downer Grove, Illinois, United States

Internation Center for Spinal Cord Injury at the Kennedy Krieger Institute

Baltimore, Maryland, United States

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Marquette University Neuro Recovery Clinic

Milwaukee, Wisconsin, United States