Status:
NOT_YET_RECRUITING
Feasibility of Home Based Transcutaneous Spinal Cord Stimulation for Persons With SCI
Lead Sponsor:
VA Palo Alto Health Care System
Collaborating Sponsors:
ONWARD Medical, Inc.
Conditions:
Tetraplegia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The proposed study will focus on the feasibility of and effectiveness to a home-based program for persons with chronic SCI focused on upper limb training augmented with a transcutaneous neurostimulato...
Detailed Description
The overarching goal of this study is to train participants with tetraplegia and their companion to operate a non-invasive surface applied neurostimulation unit (ONWARD, ARCex) while performing a pres...
Eligibility Criteria
Inclusion
- Veteran
- Age 18-65
- All gender, any ethnicity
- Cervical Spinal Cord Injury C2-8
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) B, C or D
- GRASSP-Prehension Score \>10 or GRASSP Strength Score \>30
- Greater than 1 year post injury
- Able to identify a companion to assist with neurostimulator setup in home environment.
- Internet connection to support video telehealth connection
- Willingness to travel to the VA Palo Alto Medical Center
Exclusion
- Cardiopulmonary disease or cardiac symptoms,
- Autonomic dysreflexia that is uncontrolled or severe,
- Implanted medical device(s),
- Uncontrolled spasms that could limit participation in exercise training,
- Skin breakdown or active pressure injury in areas of electrode placement.
- Participants must not be engaged in any concurrent drug or device trial
- Pregnant, are planning to become pregnant, or breastfeeding
- The study is not deemed safe or appropriate in the opinion of the investigators
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06140706
Start Date
September 1 2025
End Date
December 31 2027
Last Update
April 10 2025
Active Locations (1)
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1
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304