Feasibility of Home Based Transcutaneous Spinal Cord Stimulation for Persons With SCI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcutaneous Spinal Cord Stimulation (tSCS).
- Who it may be relevant to
- Registry conditions: Tetraplegia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility of a Video Telehealth Model to Evaluate Home Use of Transcutaneous Spinal Cord Stimulation for Enhanced Upper Limb Function
Overview
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.
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 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.
Interventions
- Behavioral 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.
Primary outcome measures
- NASA-TLX (NASA Task Load Index) [Time frame: At 8 weeks (after completion of home program)]
- QUEST 2.0 (Quebec User Evaluation of Satisfaction with assistive Technology) [Time frame: At 8 weeks (after completion of home program)]
Secondary outcome measures (4)
- 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)]
- CUE-Q (Capabilities of Upper Extremity Function) [Time frame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)]
- DASH (Disabilities of the Arm, Shoulder, and Hand) [Time frame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)]
- COPM (Canadian Occupational Performance Measure) [Time frame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- VA Palo Alto Health Care System — Palo Alto
Identifiers
NCT: NCT06140706 · IRB-68905