Spinal Stimulation for Upper Extremity Recovery in the Home

Not Applicable

Not yet recruiting

• Conditions: Cervical Spinal Cord Injury

• Registration Number: NCT06743607
• Lead Sponsor: Craig Hospital

Brief Summary

The purpose of this research is to evaluate the safety, feasibility, and tolerability of non-invasive spinal stimulation used in the home and/or community in combination with a functional home exercise program for the upper extremities (arm/hand function) as well as their combined impacts on changes in upper extremity function. The expected duration of participation in this study is about 31-33 hours over a 13-25-week period. Enrollees in this study will be randomly assigned to one of two groups: 1) upper extremity functional task-specific training combined with non-invasive transcutaneous spinal stimulation, or 2) waitlist control, which involves the same intervention, but with a 12-week delayed start. Participants complete initial testing (one time if in group one and three times \[at weeks 0, 8, and 12\] if in group two), 24 1-hour training sessions (2x/week in home with caregiver/companion support and 1x/week with research team in person or via video conference for 8 weeks), a post-treatment evaluation, and a final evaluation (4 weeks after post-treatment).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Study Start: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Age 18 or older
• History of traumatic SCI
• Less than 12 months post SCI
• SCI injury level C1-C8
• SCI categorized as AIS B-D
• Have passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows
• Have caregiver support to attend three in-person sessions and ongoing training at home
• Have a caregiver who, in the judgment of the research team, is qualified to assist the participant in the safe use of TSS
• Able to complete in-person training sessions and return to Craig Hospital for assessments
• Experience no complicating physical or cognitive conditions as determined by their physician that would preclude the safe use of electrical stimulation
• If using prescribed anti-spasticity medications, must be at a stable dose for at least four weeks prior to starting study procedures
• Agrees to comply with investigational devices instructions for use, protocol visits, and return of the device
• Able to provide informed consent

Exclusion Criteria

• Experience unstable chronic cardiac or respiratory complaints
• Have a recent history of fracture, contractures, or skin pressure injuries that might interfere with the intervention
• Received Botox injections to the UEs, neck, or hands within the last three months
• Pregnant, planning to become pregnant, or currently breastfeeding
• Have breakdown in skin area that will come into contact with electrodes
• Prior nerve or tendon transfer procedure for the UEs
• Concurrently are participating in another drug or device trial that may interfere with this study
• Have an implanted pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intrathecal pump
• In the opinion of the investigators, the study is not safe or appropriate for the participant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Capabilities of Upper Extremity Questionnaire (CUE-Q)	Weeks 0, 8, 12, 21, and 25	The CUE-Q version 2.1 measures functional limitation and perceived difficulty of performing actions with upper extremities in individuals with tetraplegia. The CUE-Q has 32 items; each scored on a 1-to-7-point scale representing self-perceived difficulty with total scores ranging from 32 to 224 (higher scores demonstrating greater UE function) and right and left scores assessed separately

Secondary Outcome Measures

Name	Time	Method
Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP)	Weeks 0, 8, 12, 21, and 25	This multimodal test measures sensorimotor and prehension function in three domains important in describing arm and hand function
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)	Weeks 0, 8, 12, 21, and 25	The ISNCSCI is a universal classification tool for SCI based on a standardized sensory and motor exam. The ISNCSCI involves a detailed examination to determine the sensory and motor levels for both the right and left sides, the overall neurological level of the injury, and the completeness of the injury as designated by the American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS). The motor exam also results in a total Upper Extremity Motor Score (UEMS) ranging from 0 to 50, with higher scores indicative of greater UE strength.
Pinch and Grasp Force	Weeks 0, 8, 12, 21, and 25	Pinch and grasp force will be measured by the Commander Echo Console with the JTech Pinch and Hand Dynamometer to quantify finger and grasp strength.
Global Rating of Change (GRC)	Weeks 8, 12, 21, and 25	The GRC assesses perceived change from an intervention. The scale is designed to quantify an individual's perceived improvement or deterioration over time. The magnitude of the change is then scored on a visual analog scale. GRC scales have been recommended for use as a core outcome measure in rehabilitation studies to improve the applicability of information from clinical trials to clinical practice.
Satisfaction with Treatment Scale	Weeks 8, 12, 21, and 25	The Satisfaction with Treatment Scale is a 6-point scale (0=strongly disagree; 5= strongly agree) used to rate satisfaction with treatment in previous intervention studies conducted in the home environment85 and will be modified specifically to address the transcutaneous spinal stimulation (TSS) intervention.
Qualitative Questions	Weeks 8 and 21	Participants and caregivers will be asked questions regarding their experience during the intervention, such as their likes and dislikes, notable changes or observations, and overall satisfaction with using TSS in their homes
Canadian Occupational Performance Measure (COPM)	Weeks 0, 8, 12, 21, and 25	The COPM is an individualized, client-centered instrument designed to measure an individual's self-perception of physical functioning and satisfaction in the activities identified as important by the client. The COPM will directly assess the true importance of functional improvements with regard to the subject's ability to perform activities of daily living and/or to function occupationally.
International Spinal Cord Injury Quality of Life Basic Data Set (QoL-BDS) Version 2.0	Weeks 0, 8, 12, 21, and 25	This instrument measures self-reported quality of life across four domains: overall well-being, physical health, psychological health, and social life. For each domain, respondents are asked to rate their satisfaction on a 0-10 scale (0=completely dissatisfied; 10=completely satisfied).
International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) Version 3.0	Weeks 0, 8, 12, 21, and 25	This instrument identifies pain region, pain type (e.g., nociceptive, neuropathic), and treatments used to reduce pain in addition to pain intensity on a 0-10 scale (0=no pain; 10=pain as bad as you can imagine) and interference with various aspects of the respondent's life on a 0-10 scale (0=no interference; 10=extreme interference).

Trial Locations

Locations (1)

Craig Hospital; 🇺🇸 Englewood, Colorado, United States