At-home spinal stimulation to improve arm and hand function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional study tests whether non-invasive transcutaneous spinal stimulation combined with a functional home exercise program can be delivered safely and effectively in the home to improve upper extremity function after cervical spinal cord injury. Adults with traumatic cervical SCI (AIS B–D) less than 12 months post-injury are randomly assigned to immediate treatment or a 12-week waitlist-delayed group. Participants complete baseline testing, then 24 one-hour training sessions over 8 weeks (two caregiver-guided at home and one with the research team in person or by video each week) plus follow-up assessments over a roughly 13–25 week participation period totaling about 31–33 hours. The single-center study at Craig Hospital focuses on safety, feasibility, tolerability, and changes in arm and hand function.

Why it matters

Who can join: the full rules

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 it's running

• Craig Hospital
  Englewood, Colorado, United States Recruiting

Study contacts

• Study coordinator: Candy Tefertiller, PT, DPT, PhD, NCS
• Email: ctefertiller@craighospital.org
• Phone: 303-789-8000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.