Actively Recruiting

Phase Not Applicable
Age: 21Years - 70Years
All Genders
NCT05267951

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

Led by University of Washington · Updated on 2025-03-05

9

Participants Needed

1

Research Sites

189 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 21 to 70 years
  • Cervical (C8 or higher), incomplete traumatic spinal cord injury, at least 1 year post-injury
  • Difficulty with hand functions in daily life activities (e.g., dressing, grooming, feeding)
  • Stable medical condition without cardiopulmonary disease or autonomic dysreflexia that prevents rehabilitation
  • Able to perform simple cued motor tasks
  • Able to attend intervention and assessment sessions three times per week
  • Have adequate social support for participation throughout 40 weeks
  • Able to read and speak English
Not Eligible

You will not qualify if you...

  • Dependent on ventilation support
  • Has implanted stimulators (e.g., pacemaker, vagus nerve stimulator, cochlear implant) or baclofen pump
  • Has metallic devices or implants in the head (e.g., deep brain stimulators, aneurysm clips/coils, stents)
  • History or symptoms of syringomyelia (progressive pain, muscle weakness, sensory loss, bowel/bladder issues)
  • Autoimmune cause of spinal cord dysfunction
  • Received botulinum toxin injections in upper extremity muscles within last 6 months
  • Had tendon transfer or nerve transfer surgery in upper extremity
  • Taking tizanidine, dantrolene, or diazepam
  • History or risk of seizures
  • History of chronic headaches or migraines
  • History of neurologic diseases such as stroke, multiple sclerosis, traumatic brain injury
  • Peripheral neuropathy (e.g., diabetic polyneuropathy, entrapment neuropathy)
  • Rheumatic diseases (e.g., rheumatoid arthritis, lupus)
  • Significant medical diseases including uncontrolled hypertension above 170/100 mmHg, cardiac or pulmonary disease, coagulation problems
  • Cardiovascular or musculoskeletal conditions preventing full participation in physical therapy
  • Unhealed fractures, contractures, pressure sores, frequent urinary tract infections or other illnesses interfering with rehabilitation
  • History of severe allergy not treatable with antihistamines
  • Alcohol or drug abuse
  • Cancer
  • Pregnant or potential to be pregnant
  • Unable to fully understand, cooperate, or safely perform study procedures
  • Unable to read or understand the consent form

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

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Research Team

F

Fatma Inanici, MD., Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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