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

Tetraplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06140706
• Other study ID #: IRB-68905
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: VA Palo Alto Health Care System
• Contact: Jeffrey Jaramillo, DPT
• Phone: 650-493-5000
• Email: jeffrey.jaramillo[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Quadriplegia
• Tetraplegia

Intervention

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.

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Palo Alto Health Care System	ONWARD Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NASA-TLX (NASA Task Load Index)	Measures subjective mental work load & physical effort	At 8 weeks (after completion of home program)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)