Feasibility of Home Based Transcutaneous Spinal Cord Stimulation for Persons With SCI

VA Palo Alto Health Care System

Status: Not yet enrolling

Conditions: Tetraplegia

Treatments: Behavioral: transcutaneous Spinal Cord Stimulation (tSCS)

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT06140706

IRB-68905

Details and patient eligibility

About

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 neurostimulator supported via a video telehealth platform.

Full 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 prescriptive functional task based upper extremity home program for 2 months. Participants will be supported with video-telehealth to assist with any difficulties that may arise and to progress their upper extremity home program. Evaluations will assess the feasibility of this video telehealth supported model as measured by the ease of use of the technology (QUEST 2.0, NASA-TLX) as well as participants ability to attend and complete all the training visits. Changes in upper extremity physical function will be measured using validated clinical tools (GRASSP, CUE-Q, DASH, COPM) as well as detailed evaluation of upper extremity muscle activation from surface EMG and strength measurements of pinch and grasp.

The primary outcome measure of this study is feasibility, and the secondary outcome measure is to capture changes in upper extremity performance.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Veteran
2. Age 18-65
3. All gender, any ethnicity
4. Cervical Spinal Cord Injury C2-8
5. American Spinal Injury Association (ASIA) Impairment Scale (AIS) B, C or D
6. GRASSP-Prehension Score >10 or GRASSP Strength Score >30
7. Greater than 1 year post injury
8. Able to identify a companion to assist with neurostimulator setup in home environment.
9. Internet connection to support video telehealth connection
10. Willingness to travel to the VA Palo Alto Medical Center

Exclusion criteria

1. Cardiopulmonary disease or cardiac symptoms,
2. Autonomic dysreflexia that is uncontrolled or severe,
3. Implanted medical device(s),
4. Uncontrolled spasms that could limit participation in exercise training,
5. Skin breakdown or active pressure injury in areas of electrode placement.
6. Participants must not be engaged in any concurrent drug or device trial
7. Pregnant, are planning to become pregnant, or breastfeeding
8. The study is not deemed safe or appropriate in the opinion of the investigators

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

tSCS plus home tele-video support

Experimental group

Description:

Cervical transcutaneous spinal stimulation during home tele-video visits

Treatment:

Behavioral: transcutaneous Spinal Cord Stimulation (tSCS)