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NCT Number: NCT06743607

Spinal Stimulation for Upper Extremity Recovery in the Home

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate intervention

Behavioral

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

Behavioral

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 outcomes

  1. Capabilities of Upper Extremity Questionnaire (CUE-Q)

    Time frame: Weeks 0, 8, 12, 21, and 25

    The CUE-Q version 2.1 measures functional limitation and perceived difficulty of performing actions with upper extremities in individuals with tetraplegia. The CUE-Q has 32 items; each scored on a 1-to-7-point scale representing self-perceived difficulty with total scores ranging from 32 to 224 (higher scores demonstrating greater UE function) and right and left scores assessed separately

Secondary outcomes

  1. Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP)

    Time frame: Weeks 0, 8, 12, 21, and 25

    This multimodal test measures sensorimotor and prehension function in three domains important in describing arm and hand function

  2. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)

    Time frame: Weeks 0, 8, 12, 21, and 25

    The ISNCSCI is a universal classification tool for SCI based on a standardized sensory and motor exam. The ISNCSCI involves a detailed examination to determine the sensory and motor levels for both the right and left sides, the overall neurological level of the injury, and the completeness of the injury as designated by the American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS). The motor exam also results in a total Upper Extremity Motor Score (UEMS) ranging from 0 to 50, with higher scores indicative of greater UE strength.

  3. Pinch and Grasp Force

    Time frame: Weeks 0, 8, 12, 21, and 25

    Pinch and grasp force will be measured by the Commander Echo Console with the JTech Pinch and Hand Dynamometer to quantify finger and grasp strength.

  4. Global Rating of Change (GRC)

    Time frame: Weeks 8, 12, 21, and 25

    The GRC assesses perceived change from an intervention. The scale is designed to quantify an individual's perceived improvement or deterioration over time. The magnitude of the change is then scored on a visual analog scale. GRC scales have been recommended for use as a core outcome measure in rehabilitation studies to improve the applicability of information from clinical trials to clinical practice.

  5. Satisfaction with Treatment Scale

    Time frame: Weeks 8, 12, 21, and 25

    The Satisfaction with Treatment Scale is a 6-point scale (0=strongly disagree; 5= strongly agree) used to rate satisfaction with treatment in previous intervention studies conducted in the home environment85 and will be modified specifically to address the transcutaneous spinal stimulation (TSS) intervention.

  6. Qualitative Questions

    Time frame: Weeks 8 and 21

    Participants and caregivers will be asked questions regarding their experience during the intervention, such as their likes and dislikes, notable changes or observations, and overall satisfaction with using TSS in their homes

  7. Canadian Occupational Performance Measure (COPM)

    Time frame: Weeks 0, 8, 12, 21, and 25

    The COPM is an individualized, client-centered instrument designed to measure an individual's self-perception of physical functioning and satisfaction in the activities identified as important by the client. The COPM will directly assess the true importance of functional improvements with regard to the subject's ability to perform activities of daily living and/or to function occupationally.

  8. International Spinal Cord Injury Quality of Life Basic Data Set (QoL-BDS) Version 2.0

    Time frame: Weeks 0, 8, 12, 21, and 25

    This instrument measures self-reported quality of life across four domains: overall well-being, physical health, psychological health, and social life. For each domain, respondents are asked to rate their satisfaction on a 0-10 scale (0=completely dissatisfied; 10=completely satisfied).

  9. International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) Version 3.0

    Time frame: Weeks 0, 8, 12, 21, and 25

    This instrument identifies pain region, pain type (e.g., nociceptive, neuropathic), and treatments used to reduce pain in addition to pain intensity on a 0-10 scale (0=no pain; 10=pain as bad as you can imagine) and interference with various aspects of the respondent's life on a 0-10 scale (0=no interference; 10=extreme interference).

Other outcomes

  1. Demographic Information

    Time frame: Week 0

    Demographic information will include: age, sex, race/ethnic background, pre-injury education, employment status, marital status, and living situation.

  2. Injury Characteristics

    Time frame: Week 0

    Injury information will include: date of injury, cause of injury, baseline AIS classification, and injury level.

Study contacts

Contact information is provided by the study sponsor or research team.

Bria Mellick, MS

CONTACT

[email protected]

303-789-8757

Candy Tefertiller, PT, DPT, PhD, NCS

CONTACT

[email protected]

303-789-8000

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Official study title

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

Acronym: SURe

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2024
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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