Phase
Condition
Spinal Cord Injuries
Treatment
Close-loop Stimulation
Open-loop Stimulation
Functional Task Practice
Clinical Study ID
Ages 21-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
has cervical (C8 or higher), incomplete (American Spinal Cord Injury ImpairmentScale - C or D) traumatic spinal cord injury, minimum 1-year post-injury
has difficulty with hand functions in activities of daily living (e.g., dressing,grooming, feeding)
stable medical condition without cardiopulmonary disease or autonomic dysreflexiathat would contraindicate participation in upper extremity rehabilitation or testingactivities
capable of performing simple cued motor tasks
has ability to attend intervention/functional task training and assessment sessions 3 times/week
has adequate social support to participate in all intervention andbaseline/follow-up assessment sessions throughout 40 weeks.
has ability to read and speak English
Exclusion
Exclusion Criteria:
dependent on ventilation support
has implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant,etc.) or baclofen pump
has metallic devices and implants in the head (e.g., deep brain stimulators,aneurysm clips/coils, and stents, vagus nerve stimulators)
has a history or current signs/symptoms of syringomyelia (progressive pain, muscleweakness, and/or sensory loss; deterioration of bowel/bladder function)
has autoimmune etiology of spinal cord dysfunction/injury
has received botulinum toxin injections in upper extremity muscles in the prior 6months
has tendon transfer or nerve transfer surgery in the upper extremity,
taking tizanidine, dantrolene or diazepam
has history of seizures or increased risk for seizures
has history of chronic headaches or migraines
has history of neurologic diseases, such as stroke, multiple sclerosis, traumaticbrain injury, etc.
has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
has rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
has significant medical disease; including uncontrolled systemic hypertension withvalues above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulationabnormalities or need for therapeutic anticoagulation
has cardiovascular or musculoskeletal disease or injury that would prevent fullparticipation in physical therapy intervention
unhealed fracture, contracture, pressure sore, or frequent urinary tract infectionsor other illnesses that might interfere with upper extremity rehabilitation ortesting activities
has a history of severe allergy (i.e., allergic reaction that could not be treatedwith antihistaminic medication
has alcohol and/or drug abuse (subject's verbal statement)
has cancer
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.)
lack of ability to fully comprehend, cooperate and/or safely perform studyprocedures in the investigator's opinion/judgment
unable to read and/or comprehend the consent form
Study Design
Study Description
Connect with a study center
University of Washington
Seattle, Washington 98195
United StatesActive - Recruiting
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