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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tetraplegia
• Intervention / Treatment: Behavioral: transcutaneous Spinal Cord Stimulation (tSCS)

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeffrey Jaramillo, DPT; Phone Number: 62286 650-493-5000; Email: jeffrey.jaramillo@va.gov
• Study Contact Backup: Name: Jenny Kiratli, PhD; Phone Number: 65095 650-493-5000; Email: jenny.kiratli@va.gov

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tSCS plus home tele-video support; Cervical transcutaneous spinal stimulation during home tele-video visits	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NASA-TLX (NASA Task Load Index)	Measures subjective mental work load & physical effort	At 8 weeks (after completion of home program)
QUEST 2.0 (Quebec User Evaluation of Satisfaction with assistive Technology)	Measures usability of device (eg, adjustability, comfort, safety and effectiveness)	At 8 weeks (after completion of home program)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GRASSP (The Graded Redefined Assessment of Strength Sensibility and Prehension)	Measures upper limb sensation, strength, and prehension	At entry (Baseline) and repeated at 8 weeks (after completion of home program)
CUE-Q (Capabilities of Upper Extremity Function)	Measures functional limitation and difficulty in performing upper limb activities	At entry (Baseline) and repeated at 8 weeks (after completion of home program)
DASH (Disabilities of the Arm, Shoulder, and Hand)	Measures upper limb function during ADL tasks, work activities, recreational sports, and pain-related limitations	At entry (Baseline) and repeated at 8 weeks (after completion of home program)
COPM (Canadian Occupational Performance Measure)	Measures performance & satisfaction of self-identified activities in self-care, productivity and leisure	At entry (Baseline) and repeated at 8 weeks (after completion of home program)

Collaborators and Investigators

• Sponsor: VA Palo Alto Health Care System
• Collaborators: ONWARD Medical, Inc.
• Investigators: Principal Investigator: Jenny Kiratli, PhD, VA Palo Alto Health Care System

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 20, 2023

Study Record Updates

• Last Update Posted (Actual): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; exercise; telemedicine; spinal cord stimulation; paralysis
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Quadriplegia
• Other Study ID Numbers: IRB-68905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No