Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury

NCT03184792 | Completed Results DMC FDA Device

• 1 other identifier: STUDY00002985
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Stimulation of the spinal cord may induce the growth and reorganization of neural pathways leading to the re-animation of paralyzed limbs. Growing evidence indicates that electrical spinal cord stimulation improves motor functions immediately via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated and painless transcutaneous electrical stimulation strategy was demonstrated to be effective for improving lower limb motor function in healthy individuals and in patients with spinal cord injury. The investigators hypothesize that transcutaneous cervical electrical stimulation can enhance conscious motor control and functions of hand and arm via neuromodulation of spinal network. This study is a prospective efficacy trial of transcutaneous cervical electrical stimulation for improving upper limb function in patients with traumatic or degenerative cervical spinal cord injury. Transcutaneous electrical spinal stimulation device is not regulated by the United States Food and Drug Administration for treatment of spinal cord injury. The interventions include either transcutaneous cervical spinal electrical stimulation combined with physical therapy or physical therapy only. The order of the interventions will be randomized for each subject in a delayed cross-over design. Total duration of the study is 6 months, including 4 weeks baseline measurements, 8 weeks intervention and 12 weeks follow-up. Both immediate and lasting improvements in hand motor and sensory function via transcutaneous cervical spinal stimulation will be evaluated.

Conditions

Spinal Cord Injury Cervical; Upper Extremity Dysfunction

Keywords

Spinal electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Graded and Redefined Assessment of Strength, Sensibility and Prehension Test (GRASSP Test)

  GRASSP is a clinical impairment measurement tool that quantifies hand impairment caused by cervical spinal cord injury. The tool measures three domains of function: strength (manual muscle strength testing), sensibility (Semmes-Weinstein monofilament sensation test), and prehension (ability and performance to generate various grasp and pinch movements using a water bottle, jar, key, pegs, coins, and nuts). The total score is calculated as the sum of the subscale scores. The minimum score is zero, and the maximum score is 232 points. Higher Scores mean a better outcome. Score change before and after each intervention is calculated.

  6 months

Secondary Outcomes (6)

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

  6 months

• Grip and Pinch Strength

  6 months

• Numeric Pain Rating Scale

  6 months

• Penn Spasm Score

  6 months

• Spinal Cord Independence Measure (SCIM)

  6 months

Study Arms (2)

Physical therapy only (Arm A)

ACTIVE COMPARATOR

Physical therapy that targets the rehabilitation of upper extremity functions

Other: Physical therapy

Transcutaneous cervical electrical stimulation combined with physical therapy (Arm B)

EXPERIMENTAL

Application of Transcutaneous cervical electrical stimulation combined with physical therapy that targets the rehabilitation of upper extremity functions

Device: Transcutaneous spinal stimulation; Other: Physical therapy

Interventions

Transcutaneous spinal stimulation DEVICE

Non-invasive electrical stimulation of cervical spinal cord over the skin

Transcutaneous cervical electrical stimulation combined with physical therapy (Arm B)

Physical therapy OTHER

Physical therapy to improve arm and hand functions

Also known as: Exercise therapy

Physical therapy only (Arm A); Transcutaneous cervical electrical stimulation combined with physical therapy (Arm B)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cervical (C7 or higher) spinal cord injury at least 1-year duration
• Incomplete spinal cord injury (American Spinal Injury Association Impairment Scale (AIS) C or D)
• Between 21 and 70 years of age
• Difficulty with hand functions in activities of daily living (e.g. dressing, grooming, feeding)
• Stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities
• Capable of performing simple cued motor tasks
• Ability to attend 2 to 5 sessions of weekly physical therapy sessions and testing activities
• Adequate social support to be able to participate in weekly training and assessment sessions for the duration of 6 months within the study period.
• Ability to read and speak English

You may not qualify if:

• Autoimmune etiology of spinal cord dysfunction/injury
• History of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc.
• Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
• Rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
• Significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.
• Active cancer
• Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
• Unhealed fracture, contracture, pressure sore, or urinary tract infection or other illnesses that might interfere with upper extremity rehabilitation or testing activities
• Any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
• Pregnancy
• Tendon or nerve transfer surgery in the upper limbs
• Botulinum toxin injections in the prior 6 months
• Dependent on ventilation support
• Implanted stimulator (e.g. vagus nerve stimulator, pacemaker, cochlear implant, etc).
• Has depression or anxiety based on Patient Health Questionnaire and General Anxiety Disorder-7 item Questionnaire

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 981095, United States

Location

MeSH Terms

Interventions

Physical Therapy Modalities; Exercise Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Results Point of Contact

• Title: Dr. Fatma Inanici
• Organization: University of Washington

finanici@uw.edu

2067872692

Study Officials

• Chet T Moritz, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Rehabilitative Medicine

Model Details: Participants will be randomized into two groups: Group 1.) Six weeks of "Physical therapy only" (Arm A) as the first intervention and then 6 weeks of "Transcutaneous spinal stimulation \& Physical therapy" (Arm B) as the second intervention. Group 2.) Six weeks of "Transcutaneous spinal stimulation \& Physical therapy" (Arm B) as the first intervention, and then "Physical therapy only" (Arm A) as the second intervention.

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 14, 2017
• Study Start: December 1, 2017
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2024
• Last Updated: November 4, 2025
• Results First Posted: November 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)