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NCT Number: NCT06140706

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

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.

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Key information

Conditions

Tetraplegia Behavior Motor Activity Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

transcutaneous Spinal Cord Stimulation (tSCS)

Behavioral

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

Primary outcomes

  1. NASA-TLX (NASA Task Load Index)

    Time frame: At 8 weeks (after completion of home program)

    Measures subjective mental work load & physical effort

  2. QUEST 2.0 (Quebec User Evaluation of Satisfaction with assistive Technology)

    Time frame: At 8 weeks (after completion of home program)

    Measures usability of device (eg, adjustability, comfort, safety and effectiveness)

Secondary outcomes

  1. GRASSP (The Graded Redefined Assessment of Strength Sensibility and Prehension)

    Time frame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)

    Measures upper limb sensation, strength, and prehension

  2. CUE-Q (Capabilities of Upper Extremity Function)

    Time frame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)

    Measures functional limitation and difficulty in performing upper limb activities

  3. DASH (Disabilities of the Arm, Shoulder, and Hand)

    Time frame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)

    Measures upper limb function during ADL tasks, work activities, recreational sports, and pain-related limitations

  4. COPM (Canadian Occupational Performance Measure)

    Time frame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)

    Measures performance & satisfaction of self-identified activities in self-care, productivity and leisure

Study contacts

Contact information is provided by the study sponsor or research team.

Jeffrey Jaramillo, DPT

CONTACT

[email protected]

650-493-5000 ext. 62286

Jenny Kiratli, PhD

CONTACT

[email protected]

650-493-5000 ext. 65095

Sponsors and collaborators

Lead sponsor

VA Palo Alto Health Care System

Fed

Collaborators

  • ONWARD Medical, Inc.

Registry information

Official study title

Feasibility of a Video Telehealth Model to Evaluate Home Use of Transcutaneous Spinal Cord Stimulation for Enhanced Upper Limb Function

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2023
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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