Spinal Stimulation for Upper Extremity Recovery in the Home

Launched by CRAIG HOSPITAL · Dec 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of non-invasive spinal stimulation to help improve arm and hand function in individuals with cervical spinal cord injuries. The goal is to see if this treatment, combined with a structured exercise program that participants can do at home, is safe and effective. If you are 18 years or older, have had a spinal cord injury within the last 12 months, and are able to participate with the support of a caregiver, you might be eligible to join this study.

Participants will be randomly placed in one of two groups: one will receive the spinal stimulation along with specific training for their arms and hands right away, while the other will wait 12 weeks before starting the same program. Over the course of about 13 to 25 weeks, participants can expect to take part in up to 31-33 hours of training, including time spent with a research team and at home with their caregiver. There will be evaluations before, during, and after the training to assess any changes in function. It's important to note that certain health conditions or treatments may prevent some individuals from being eligible, so a thorough screening process will be in place.

Gender

ALL

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