Recruiting

Transcutaneous Stimulation & Training

Sponsor:

Craig Hospital

Code:

NCT06743607

Conditions

Cervical Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Immediate Intervention

Waitlist control

Study Details

Brief summary:

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).

Conditions

Cervical Spinal Cord Injury

Study ID

NCT06743607

Start date

May 28, 2025

Status verified date

Mar, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Immediate Intervention

For the immediate intervention group, each participant will complete the following:

  • Initial baseline evaluation
  • 24 training sessions (3x/week for eight weeks) of UE Functional Task Practice (FTP)+TSS (two training sessions/week will be completed in the home with caregiver/companion support; the third weekly session will be conducted via videoconference with a research therapist)
  • Post-treatment evaluation (after eight weeks of training) and follow-up evaluation (four weeks after post-treatment evaluation).
  • Post-treatment and follow-up assessments will be conducted over two days: assessments completed without TSS on day one and with TSS on day two.

active comparator: Waitlist Control

The waitlist control group will participate in a protocol similar to the immediate intervention group, except:

  • 12-week waiting period before starting the active intervention.
  • Assessments will be completed at 0, 8, and 12 weeks before starting the active intervention to control for spontaneous recovery.
  • Post-treatment evaluation (after eight weeks of training)
  • Follow-up assessment (four weeks after the post-treatment evaluation).

Interventions

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.

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 measure

  • Capabilities of Upper Extremity Questionnaire (CUE-Q) [ Time Frame: Weeks 0, 8, 12, 21, and 25 ]

Central Contacts and Locations

Central contacts

Candy Tefertiller, PT, DPT, PhD, NCS

303-789-8000ctefertiller@craighospital.org

Bria Mellick, MS

303-789-8757bmellick@craighospital.org

Locations

Craig Hospital

Recruiting

Englewood, Colorado, United States, 80113

Contacts

Candy Tefertiller, PT, DPT, PhD, NCS

303-789-8000ctefertiller@craighospital.org

Bria Mellick, MS

303-789-8757bmellick@craighospital.org

Principal Investigator:

Candy Tefertiller, PT, DPT, PhD, NCS

More Information

Sponsor

Craig Hospital

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Craig Hospital on 2026-03-31.