Spinal Stimulation for Upper Extremity Recovery in the Home

ConditionCervical Spinal Cord Injury

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCraig Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

History of traumatic SCI

Less than 12 months post SCI

SCI injury level C1-C8

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

46 Participants

are divided into 2 treatment groups

Group A: Immediate InterventionActive comparator 1 intervention

Group B: Waitlist ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

Capabilities of Upper Extremity Questionnaire (CUE-Q)

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

Time frame

Weeks 0, 8, 12, 21, and 25

Secondary outcomes

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

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

Time frame

Weeks 0, 8, 12, 21, and 25

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

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.

Time frame

Weeks 0, 8, 12, 21, and 25

Pinch and Grasp Force

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.

Time frame

Weeks 0, 8, 12, 21, and 25

Global Rating of Change (GRC)

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.

Time frame

Weeks 8, 12, 21, and 25

Other outcomes

Demographic Information

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

Time frame

Week 0

Injury Characteristics

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

Time frame

Week 0