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Recruiting NCT06743607

Spinal Stimulation for Upper Extremity Recovery in the Home

No phase Interventional Cervical Spinal Cord Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immediate Intervention, Waitlist control.
Who it may be relevant to
Registry conditions: Cervical Spinal Cord Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Spinal Stimulation to Improve Upper Extremity Recovery in the Home (SSTIM UE Recover [SURe])

Overview

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]
Secondary outcome measures (9)
  • Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) [Time frame: Weeks 0, 8, 12, 21, and 25]
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) [Time frame: Weeks 0, 8, 12, 21, and 25]
  • Pinch and Grasp Force [Time frame: Weeks 0, 8, 12, 21, and 25]
  • Global Rating of Change (GRC) [Time frame: Weeks 8, 12, 21, and 25]
  • Satisfaction with Treatment Scale [Time frame: Weeks 8, 12, 21, and 25]
  • Qualitative Questions [Time frame: Weeks 8 and 21]
  • Canadian Occupational Performance Measure (COPM) [Time frame: Weeks 0, 8, 12, 21, and 25]
  • International Spinal Cord Injury Quality of Life Basic Data Set (QoL-BDS) Version 2.0 [Time frame: Weeks 0, 8, 12, 21, and 25]
  • International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) Version 3.0 [Time frame: Weeks 0, 8, 12, 21, and 25]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Craig Hospital — Englewood

Identifiers

NCT: NCT06743607 · 2274573-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗