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NCT Number: NCT03184792

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

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.

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Key information

Conditions

Spinal Cord Injury Cervical Upper Extremity Dysfunction

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 981095, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Diagnosed with syringomyelia
  • Alcohol and/or drug abuse.
  • Cognitive impairment based on Short Portable Mental Status Questionnaire
  • Unable to read and/or comprehend the consent form.
  • Unable to understand the instructions given as part of the study.

Treatment and study plan

Transcutaneous spinal stimulation

Device

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

Physical Therapy

Other

Physical therapy to improve arm and hand functions

Other names: Exercise therapy

Primary outcomes

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

    Time frame: 6 months

    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.

Secondary outcomes

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

    Time frame: 6 months

    International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination Subscale 1: Myotomal-based Motor Examination - measures the motor function of the extremities. The minimum score is zero, and the maximum score is 100. Higher scores represent better outcomes.

    Subscale 2: The Dermatomal-based Sensory Examination - measures the sensory function of the whole body dermatomes. The minimum score is zero, and the maximum score is 224. Higher scores represent better outcomes.

  2. Grip and Pinch Strength

    Time frame: 6 months

    Hand strength measurement by dynamometry.

    The change in strength (improvement) before and at the end of each intervention arm is calculated.

  3. Numeric Pain Rating Scale

    Time frame: 6 months

    Patient reported pain rating on a 0 to 10 scale. The mean score change (improvement) before and at the end of each intervention arm is calculated.

    Zero means no pain, 10 means the worst pain one can imagine. Higher scores mean worse pain.

  4. Penn Spasm Score

    Time frame: 6 months

    Patient-reported spasm rating. Scores are mild (0), moderate (1), and severe (2).

  5. Spinal Cord Independence Measure (SCIM)

    Time frame: 6 months

    Clinician-administered disability questionnaire for patients with spinal cord lesions.

    The total SCIM scores range from 0 to 100. Higher scores mean better outcomes. Score change (improvement) relative to baseline or previous intervention arm is calculated.

  6. World Health Organization-Quality of Life - (WHO-QoL-BREF)

    Time frame: 6 months

    Patient-reported quality of life scale. A higher score indicates a higher quality of life. Score change (improvement) relative to baseline or prior intervention arm is calculated.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Activity Dependent Rehabilitation Via Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury

Acronym: ADDRESS

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2017
Registry last updated
Nov 4, 2025

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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