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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transspinal Stimulation Plus Locomotor Training for SCI

NCT04807764

Spinal Cord Injuries Paraplegia, Spinal Tetraplegia/Tetraparesis +1 more

COMPLETED NA

Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury

NCT05267951

Spinal Cord Injuries

RECRUITING NA

Neural Facilitation of Movements in People With SCI

NCT05354206

Spinal Cord Injuries

TERMINATED NA

Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis

NCT04755699

Healthy Volunteers Spinal Cord Injury Stroke +3 more

RECRUITING EARLY_PHASE1

High Definition Neuromuscular Stimulation in Tetraplegia

NCT04075812

Spinal Cord Injury at C4-C6 Level

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tetraplegia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

tSCS plus home tele-video support

Cervical transcutaneous spinal stimulation during home tele-video visits

Group Type EXPERIMENTAL

transcutaneous Spinal Cord Stimulation (tSCS)

Intervention Type BEHAVIORAL

Neurostimulation for upper extremity training, delivered through video telehealth, 8 weeks of home use for (i) feasibility and (ii) potential functional improvement.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

transcutaneous Spinal Cord Stimulation (tSCS)

Neurostimulation for upper extremity training, delivered through video telehealth, 8 weeks of home use for (i) feasibility and (ii) potential functional improvement.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No