Spinal Stimulation and Exercise for Spinal Cord Injury

Overseen By Chet Moritz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Anticoagulants, Osteoporosis medications

Disqualifiers: Autoimmune, Neurologic, Cancer, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Growing evidence indicates that electrical spinal cord stimulation improves motor functions both immediately and over the long term via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated, and painless lumbosacral transcutaneous electrical stimulation strategy was demonstrated to be effective in improving lower limb motor function in participants with spinal cord injury. Our current project, cervical transcutaneous electrical stimulation and intensive exercise for arms and hands are also revealing a significant improvement in upper extremity function. Additionally, the subject and caregiver noted that stair climbing ability has been substantially enhanced starting from the first week of cervical stimulation treatment and continues to date. This study is a prospective efficacy trial of combined transcutaneous cervical and lumbosacral electrical stimulation with intensive physical therapy for improving locomotion in people with incomplete tetraplegia and paraplegia. This experiment design consists of two to four-phase intervention programs, including one-month physical therapy only followed by one-month spinal stimulation combined with physical therapy. Between each intervention, washout periods of up to one month may be used to determine any after-effects of the interventions. The intervention arms will be repeated if the functional improvement does not reach a plateau during the first two months of interventions. Sessions will last up to 2 hours/day, 2 to 5 days/week for each arm. Both immediate and lasting improvements in lower extremity function and autonomic function via transcutaneous spinal stimulation and intensive physical therapy will be evaluated.

Eligibility Criteria

This trial is for adults aged 21-70 with spinal cord injuries at T12 or higher, lasting over a year. Participants should be able to perform simple tasks and have mobility issues but must not have severe medical conditions like heart disease or uncontrolled high blood pressure. They need to commit up to five times weekly for therapy sessions and assessments in English, without significant depression or anxiety.

Inclusion Criteria

I am between 21 and 70 years old.

My doctor has approved me for walking training.

Has the ability to read and speak English

Exclusion Criteria

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

I have a condition that could affect my ability to participate in leg exercises or tests.

I understand the instructions given in the study.

Treatment Details

Interventions

• Physical Therapy
• Transcutaneous Spinal Stimulation

Trial Overview The study tests the effectiveness of non-invasive electrical stimulation on the neck and lower back combined with intensive physical therapy to improve movement in people with incomplete tetraplegia and paraplegia. It involves phases of just physical therapy followed by both therapies together, assessing immediate and long-term improvements.

Participant Groups

Group I: Transcutaneous spinal stimulation & Physical therapy Active Control 2 Interventions

Transcutaneous electrical stimulation combined with physical therapy that targets rehabilitation of walking and standing functions

Group II: Physical therapy only Active Control 1 Intervention

Physical therapy that targets rehabilitation of walking and standing functions

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+