Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury

Last updated: February 28, 2025
Sponsor: University of Washington
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

Close-loop Stimulation

Open-loop Stimulation

Functional Task Practice

Clinical Study ID

NCT05267951
STUDY00013469
  • Ages 21-70
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy of non-invasive (transcutaneous) closed-loop electrical spinal cord stimulation for recovery of upper limb function (Aim

  1. and spasticity (Aim 2) following spinal cord injury.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. has cervical (C8 or higher), incomplete (American Spinal Cord Injury ImpairmentScale - C or D) traumatic spinal cord injury, minimum 1-year post-injury

  2. has difficulty with hand functions in activities of daily living (e.g., dressing,grooming, feeding)

  3. stable medical condition without cardiopulmonary disease or autonomic dysreflexiathat would contraindicate participation in upper extremity rehabilitation or testingactivities

  4. capable of performing simple cued motor tasks

  5. has ability to attend intervention/functional task training and assessment sessions 3 times/week

  6. has adequate social support to participate in all intervention andbaseline/follow-up assessment sessions throughout 40 weeks.

  7. has ability to read and speak English

Exclusion

Exclusion Criteria:

  1. dependent on ventilation support

  2. has implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant,etc.) or baclofen pump

  3. has metallic devices and implants in the head (e.g., deep brain stimulators,aneurysm clips/coils, and stents, vagus nerve stimulators)

  4. has a history or current signs/symptoms of syringomyelia (progressive pain, muscleweakness, and/or sensory loss; deterioration of bowel/bladder function)

  5. has autoimmune etiology of spinal cord dysfunction/injury

  6. has received botulinum toxin injections in upper extremity muscles in the prior 6months

  7. has tendon transfer or nerve transfer surgery in the upper extremity,

  8. taking tizanidine, dantrolene or diazepam

  9. has history of seizures or increased risk for seizures

  10. has history of chronic headaches or migraines

  11. has history of neurologic diseases, such as stroke, multiple sclerosis, traumaticbrain injury, etc.

  12. has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)

  13. has rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)

  14. has significant medical disease; including uncontrolled systemic hypertension withvalues above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulationabnormalities or need for therapeutic anticoagulation

  15. has cardiovascular or musculoskeletal disease or injury that would prevent fullparticipation in physical therapy intervention

  16. unhealed fracture, contracture, pressure sore, or frequent urinary tract infectionsor other illnesses that might interfere with upper extremity rehabilitation ortesting activities

  17. has a history of severe allergy (i.e., allergic reaction that could not be treatedwith antihistaminic medication

  18. has alcohol and/or drug abuse (subject's verbal statement)

  19. has cancer

  20. pregnant (Childbearing potential will be asked at screening, baseline, and everysubsequent visit in which the subject would receive transcutaneous spinal cordstimulation and/or Transcranial Magnetic Stimulation whether the participant couldbe pregnant. Pregnancy will be ruled out by an over-the-counter urine pregnancy testfor all females of childbearing potential (1) at the time of enrollment, (2) priorto all sessions that include Transcranial Magnetic Stimulation, and also prior tothe intervention phases of (3) closed-loop or (4) open-loop stimulation. Additionalpregnancy tests may be performed if there is a concern of pregnancy.)

  21. lack of ability to fully comprehend, cooperate and/or safely perform studyprocedures in the investigator's opinion/judgment

  22. unable to read and/or comprehend the consent form

Study Design

Total Participants: 9
Treatment Group(s): 3
Primary Treatment: Close-loop Stimulation
Phase:
Study Start date:
October 12, 2022
Estimated Completion Date:
June 30, 2026

Study Description

After being informed about the purpose, study timeline, and procedures, all participants giving written informed consent will undergo repeated baseline measurements throughout four weeks, followed by intensive exercise therapy for six weeks.

Next, participants will receive (1) closed-loop stimulation and (2) open-loop stimulation treatment for Aim 1 Section of the study. Stimulation will be delivered non-invasively using skin electrodes on the back of the neck. Each treatment arm will last six weeks. The investigators will determine the order of the treatment arms randomly. For closed-loop stimulation, The investigators will place a sensor on the arm muscles over the skin. This sensor will detect the movement and start the stimulation accordingly.

For Aim 2 Section, intervention arms will consist of (1) transcutaneous stimulation, followed by (2) spasticity-reducing stimulation treatment arms.

There will be a 6-week waiting period between two stimulation arms where participants will not receive any stimulation or exercise therapy. Treatments will last 90 minutes per session, three sessions per week. Overall participation in the study will last ten months: Four weeks baseline + three treatment periods (each will last six weeks) + six weeks waiting period between stimulation treatments + 12 weeks follow-up.

Connect with a study center

  • University of Washington

    Seattle, Washington 98195
    United States

    Active - Recruiting

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