Home-Based Spinal Cord Stimulation for Quadriplegia
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but you cannot participate if you are involved in another drug or device trial.
What data supports the effectiveness of the treatment Home Based Transcutaneous Spinal Cord Stimulation for quadriplegia?
Research shows that transcutaneous spinal cord stimulation (tSCS) can improve upper limb and hand function in people with spinal cord injuries, including those with complete tetraplegia. In one study, participants experienced significant improvements in hand strength and function after receiving tSCS combined with hand training, suggesting potential benefits for quadriplegia.12345
Is home-based spinal cord stimulation generally safe for humans?
How does home-based spinal cord stimulation treatment for quadriplegia differ from other treatments?
Home-based spinal cord stimulation for quadriplegia is unique because it allows patients to receive therapy in their own homes, using non-invasive electrical stimulation to enhance the excitability of the spinal network. This approach can improve motor and sensory functions by modulating the spinal cord's neural circuits, offering a novel rehabilitation method compared to traditional therapies that often require hospital visits.124910
What is the purpose of this trial?
The proposed study will focus on the feasibility of and effectiveness to a home-based program for persons with chronic SCI focused on upper limb training augmented with a transcutaneous neurostimulator supported via a video telehealth platform.
Research Team
Jenny Kiratli, PhD
Principal Investigator
VA Palo Alto Health Care System
Eligibility Criteria
This trial is for veterans aged 18-65 with chronic quadriplegia (C2-C8 spinal injury) who are at least one year post-injury and have some arm function. Participants need internet for video calls, can travel to VA Palo Alto Medical Center, and must have a helper for device setup. Excluded are those with implanted devices, skin issues where electrodes go, involved in other trials, pregnant or breastfeeding women, or if they have severe heart/lung problems or uncontrolled spasms.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Training
Participants and their companions are trained to operate the neurostimulation unit and perform upper extremity home program
Follow-up
Participants are monitored for changes in upper extremity performance and feasibility of the telehealth model
Treatment Details
Interventions
- Home Based Transcutaneous Spinal Cord Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Palo Alto Health Care System
Lead Sponsor
ONWARD Medical, Inc.
Industry Sponsor