Clinical trial NCT06743607: Spinal Stimulation for Upper Extremity Recovery in the Home
Official title: Spinal Stimulation to Improve Upper Extremity Recovery in the Home (SSTIM UE Recover [SURe])
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Spinal Cord Injury
Lead sponsor: Craig Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2024-12-20
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Capabilities of Upper Extremity Questionnaire (CUE-Q)
timeFrame: Weeks 0, 8, 12, 21, and 25
Secondary outcomes:
measure: Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP)
timeFrame: Weeks 0, 8, 12, 21, and 25
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
timeFrame: Weeks 0, 8, 12, 21, and 25
measure: Pinch and Grasp Force
timeFrame: Weeks 0, 8, 12, 21, and 25
measure: Global Rating of Change (GRC)
timeFrame: Weeks 8, 12, 21, and 25
measure: Satisfaction with Treatment Scale
timeFrame: Weeks 8, 12, 21, and 25
measure: Qualitative Questions
timeFrame: Weeks 8 and 21
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Weeks 0, 8, 12, 21, and 25
measure: International Spinal Cord Injury Quality of Life Basic Data Set (QoL-BDS) Version 2.0
timeFrame: Weeks 0, 8, 12, 21, and 25
measure: International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) Version 3.0
timeFrame: Weeks 0, 8, 12, 21, and 25
Other outcomes:
measure: Demographic Information
timeFrame: Week 0
measure: Injury Characteristics
timeFrame: Week 0
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
References: