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New treatment option for Cervical Spinal Cord Injury
Official title Spinal Stimulation for Upper Extremity Recovery in the Home
ClinicalTrials.gov ID: NCT06743607
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Englewood, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Englewood, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.