Spinal Stimulation for Upper Extremity Recovery in the Home

NCT06743607 | Recruiting

• 1 other identifier: 2274573-1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

Cervical Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Capabilities of Upper Extremity Questionnaire (CUE-Q)

  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

  Weeks 0, 8, 12, 21, and 25

Secondary Outcomes (9)

• Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP)

  Weeks 0, 8, 12, 21, and 25

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)

  Weeks 0, 8, 12, 21, and 25

• Pinch and Grasp Force

  Weeks 0, 8, 12, 21, and 25

• Global Rating of Change (GRC)

  Weeks 8, 12, 21, and 25

• Satisfaction with Treatment Scale

  Weeks 8, 12, 21, and 25

Other Outcomes (2)

• Demographic Information

  Week 0

• Injury Characteristics

  Week 0

Study Arms (2)

Immediate Intervention

ACTIVE COMPARATOR

For the immediate intervention group, each participant will complete the following: * Initial baseline evaluation * 24 training sessions (3x/week for eight weeks) of UE Functional Task Practice (FTP)+TSS (two training sessions/week will be completed in the home with caregiver/companion support; the third weekly session will be conducted via videoconference with a research therapist) * Post-treatment evaluation (after eight weeks of training) and follow-up evaluation (four weeks after post-treatment evaluation). * Post-treatment and follow-up assessments will be conducted over two days: assessments completed without TSS on day one and with TSS on day two.

Behavioral: Immediate Intervention

Waitlist Control

ACTIVE COMPARATOR

The waitlist control group will participate in a protocol similar to the immediate intervention group, except: * 12-week waiting period before starting the active intervention. * Assessments will be completed at 0, 8, and 12 weeks before starting the active intervention to control for spontaneous recovery. * Post-treatment evaluation (after eight weeks of training) * Follow-up assessment (four weeks after the post-treatment evaluation).

Behavioral: Waitlist control

Interventions

Immediate Intervention BEHAVIORAL

Participants will engage in a home exercise therapy program in combination with transcutaneous spinal stimulation intended to focus on the upper extremities that commences immediately after enrollment.

Immediate Intervention

Waitlist control BEHAVIORAL

Participants will engage in a home exercise therapy program in combination with transcutaneous spinal stimulation intended to focus on the upper extremities that commences 12 weeks after enrollment.

Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Craig Hospital: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

RECRUITING

Central Study Contacts

Candy Tefertiller, PT, DPT, PhD, NCS

CONTACT

303-789-8000; ctefertiller@craighospital.org

Bria Mellick, MS

CONTACT

303-789-8757; bmellick@craighospital.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director of Research and Evaluation

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: May 28, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)