Non-invasive spinal stimulation to improve arm function after spinal cord injury

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

This study is testing if a new type of electrical stimulation can help improve arm movement and reduce stiffness in people with spinal cord injuries.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 21 Years to 70 Years
• Sex: All
• Sponsor: University of Washington (other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT05267951 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of non-invasive closed-loop electrical spinal cord stimulation to enhance upper limb function and reduce spasticity in individuals with spinal cord injuries. Participants will undergo a series of baseline measurements followed by intensive exercise therapy, and then receive either closed-loop or open-loop stimulation treatments. The closed-loop stimulation will utilize sensors to detect muscle movement and adjust stimulation accordingly. The study spans ten months, including treatment periods and follow-up assessments.

Who should consider this trial

Good fit: Ideal candidates are individuals with cervical spinal cord injuries who have difficulty with hand functions and are at least one year post-injury.

Not a fit: Patients who are dependent on ventilation support or have implanted stimulators or metallic devices in the head may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve upper limb function and quality of life for patients with spinal cord injuries.

How similar studies have performed: Other studies have shown promise with similar non-invasive stimulation approaches, indicating potential for success in this area.

Eligibility criteria

Inclusion Criteria:

1. has cervical (C8 or higher), incomplete (American Spinal Cord Injury Impairment Scale - 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 dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities
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 and baseline/follow-up assessment sessions throughout 40 weeks.
7. has ability to read and speak English

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, muscle weakness, 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 6 months
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, traumatic brain 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 with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation
15. has cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
16. unhealed fracture, contracture, pressure sore, or frequent urinary tract infections or other illnesses that might interfere with upper extremity rehabilitation or testing activities
17. has a history of severe allergy (i.e., allergic reaction that could not be treated with 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 every subsequent visit in which the subject would receive transcutaneous spinal cord stimulation and/or Transcranial Magnetic Stimulation whether the participant could be pregnant. Pregnancy will be ruled out by an over-the-counter urine pregnancy test for all females of childbearing potential (1) at the time of enrollment, (2) prior to all sessions that include Transcranial Magnetic Stimulation, and also prior to the intervention phases of (3) closed-loop or (4) open-loop stimulation. Additional pregnancy tests may be performed if there is a concern of pregnancy.)
21. lack of ability to fully comprehend, cooperate and/or safely perform study procedures in the investigator's opinion/judgment
22. unable to read and/or comprehend the consent form

Where this trial is running

Seattle, Washington

• University of Washington — Seattle, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Chet Moritz, Ph.D. — University of Washington
• Study coordinator: Fatma Inanici, MD., Ph.D.

Conditions: Spinal Cord Injuries