Spinal Stimulation for Upper Extremity Recovery in the Home (SURe)

Craig Hospital

Status: Not yet enrolling

Conditions: Cervical Spinal Cord Injury

Treatments: Behavioral: Waitlist control; Behavioral: Immediate Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06743607

2274573-1

Details and patient eligibility

About

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).

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Immediate Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Immediate Intervention

Waitlist Control

Active Comparator group

Description:

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).

Treatment:

Behavioral: Waitlist control