Spinal Cord Stimulation for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen ByChet Moritz, Ph.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Washington

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a treatment that uses electrical signals sent through the skin to help people with spinal cord injuries improve arm movement and reduce muscle stiffness. The treatment involves placing electrodes on the neck and using sensors to detect movement. The goal is to see if this method can better help patients regain function and reduce stiffness.

Eligibility Criteria

This trial is for adults with a stable medical condition who have had a cervical spinal cord injury at least one year ago, can perform simple motor tasks, and attend sessions three times weekly. They must not be ventilator-dependent or have certain implants, drug abuse history, pregnancy, severe allergies, or other conditions that could interfere with the study.

Inclusion Criteria

I struggle with daily tasks like dressing or feeding due to hand issues.

My heart and lung health allows me to do arm exercises.

I have a spinal cord injury above my shoulders and still have some movement or sensation below the injury.

I can attend training and assessment sessions 3 times a week.

Exclusion Criteria

I have a history of neurological diseases like stroke or MS.

I have nerve damage in my hands or feet.

I do not have any unhealed injuries or frequent infections that could affect my arm rehabilitation.

I am currently taking tizanidine, dantrolene, or diazepam.

I have had botulinum toxin injections in my arm muscles within the last 6 months.

I have had surgery to move tendons or nerves in my arm or hand.

I rely on a machine to help me breathe.

I have a history of chronic headaches or migraines.

I have cancer.

I have a rheumatic disease like rheumatoid arthritis or lupus.

I have a heart or muscle condition that stops me from fully joining in physical therapy.

I have or had syringomyelia with symptoms like pain, weakness, sensory loss, or issues with bowel/bladder.

I do not have uncontrolled high blood pressure or serious heart, lung, or blood clotting issues.

My spinal cord injury is due to an autoimmune disease.

I have a history of seizures or am at high risk for seizures.

Participant Groups

The study tests non-invasive closed-loop electrical stimulation versus open-loop stimulation to improve hand function and reduce spasticity after spinal cord injuries. Participants will also engage in functional task practice as part of their therapy regimen.

2Treatment groups

Experimental Treatment

Group I: Open-loop StimulationExperimental Treatment2 Interventions

Continuous stimulation

Group II: Close-loop StimulationExperimental Treatment2 Interventions

Intended movement-based stimulation.