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Non-Invasive Spinal Cord Stimulation for Neurological Disorders

N/A

Recruiting

Led By Katherine M Steele, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who can walk 20 yards, with or without an assistive device

Must not have

Patients with unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities

Patients with active cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether non-invasive stimulation of the spinal cord can improve walking function for people with neurologic conditions.

Who is the study for?

This trial is for people with neurological conditions like cerebral palsy who can walk 20 yards and follow simple instructions. They must be medically stable, able to attend up to five therapy sessions weekly, and have support for the 11-month study period. Those with severe medical issues, uncontrolled seizures, recent musculoskeletal surgeries, or implanted devices are excluded.

What is being tested?

The study tests if non-invasive spinal stimulation combined with gait training improves walking in neurologic conditions. It's a cross-over design where participants first get only training or training plus stimulation, then switch after a break period. Each phase lasts up to 8 weeks with follow-ups for three months.

What are the potential side effects?

Potential side effects of transcutaneous spinal stimulation may include discomfort at the site of stimulation, muscle spasms, skin irritation from electrode placement, and fatigue due to increased physical activity during gait training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk 20 yards with or without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have any unhealed fractures or conditions that would stop me from doing leg exercises.

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My cancer is currently active.

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

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I have a history of seizures that are not well-controlled.

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

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I have a rheumatic disease like rheumatoid arthritis or lupus.

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I haven't had leg or back surgery in the past year that could affect study results.

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I am taking medication for my diagnosed osteoporosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months. for reporting.