Spinal Stimulation for Upper Extremity Recovery in the Home

NCT ID: NCT06743607

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2027-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Immediate Intervention

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.

Group Type: ACTIVE_COMPARATOR

Immediate Intervention

Intervention Type: 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.

Waitlist Control

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).

Group Type: ACTIVE_COMPARATOR

Waitlist control

Intervention Type: 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.

Interventions

Immediate Intervention

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.

Intervention Type: BEHAVIORAL

Waitlist control

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

Craig Hospital

OTHER

Sponsor Role: lead

Responsible Party

Candace Tefertiller

Executive Director of Research and Evaluation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Craig Hospital

Englewood, Colorado, United States

Countries

United States

Central Contacts

Candy Tefertiller, PT, DPT, PhD, NCS

Role: CONTACT

ctefertiller@craighospital.org

303-789-8000

Bria Mellick, MS

Role: CONTACT

bmellick@craighospital.org

303-789-8757

Facility Contacts

Candy Tefertiller, PT, DPT, PhD, NCS

Role: primary

ctefertiller@craighospital.org

303-789-8000

Bria Mellick, MS

Role: backup

bmellick@craighospital.org

303-789-8757

Other Identifiers

2274573-1

Identifier Type: -

Identifier Source: org_study_id