NCT06743607 · Craig Hospital
Spinal Stimulation for Upper Extremity Recovery in the Home
(SURe)
What this study is 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 (treatment group$1/hand function) as well as their combined impacts on changes in upper extremity function.
View original scientific description
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).
Interventions
BEHAVIORAL
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.
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.
Primary outcome measures
Capabilities of Upper Extremity Questionnaire (CUE-Q)
Time frame: Weeks 0, 8, 12, 21, and 25
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Englewood, Colorado
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 31, 2026 · Source of record for eligibility and locations