Clinical trial NCT06140706: Feasibility of Home Based Transcutaneous Spinal Cord Stimulation for Persons With SCI
Official title: Feasibility of a Video Telehealth Model to Evaluate Home Use of Transcutaneous Spinal Cord Stimulation for Enhanced Upper Limb Function
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tetraplegia
Keywords: paralysis
exercise
telemedicine
spinal cord stimulation
physical activity
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
Collaborators: name: ONWARD Medical, Inc.
First posted: 2023-11-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: NASA-TLX (NASA Task Load Index)
timeFrame: At 8 weeks (after completion of home program)
measure: QUEST 2.0 (Quebec User Evaluation of Satisfaction with assistive Technology)
timeFrame: At 8 weeks (after completion of home program)
Secondary outcomes:
measure: GRASSP (The Graded Redefined Assessment of Strength Sensibility and Prehension)
timeFrame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)
measure: CUE-Q (Capabilities of Upper Extremity Function)
timeFrame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)
measure: DASH (Disabilities of the Arm, Shoulder, and Hand)
timeFrame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)
measure: COPM (Canadian Occupational Performance Measure)
timeFrame: At entry (Baseline) and repeated at 8 weeks (after completion of home program)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: VA Palo Alto Health Care System
name: Jenny Kiratli, PhD
role: PRINCIPAL_INVESTIGATOR
References: