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Spinal Stimulation and Exercise for Spinal Cord Injury

N/A

Recruiting

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

Is between 21 and 70 years of age

Has spinal cord injury (T12 or higher level) of at least 1-year duration

Must not have

Has significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation

Has unhealed fracture, contracture, pressure sore, urinary tract infection, or other illnesses that might interfere with lower extremity rehabilitation or testing activities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-11 months

Awards & highlights

Summary

This trialtests if spinal cord stimulation combined with physical therapy can improve motor functions in patients with spinal cord injury.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information; however, as it's a non-invasive procedure involving electrical stimulation and exercise, some possible side effects might include mild discomfort at the stimulation site, muscle fatigue from exercise, or skin irritation.

Eligibility Criteria

Inclusion Criteria

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

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I am between 21 and 70 years old.

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I have had a spinal cord injury above my waist for over a year.

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I have trouble with daily activities due to leg function issues.

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My health is stable, and I don't have heart or lung disease that would stop me from doing leg exercises.

Exclusion Criteria

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

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

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I understand the instructions given in the study.

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I have nerve damage, such as from diabetes.

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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 rheumatic disease like rheumatoid arthritis or lupus.

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I have had fractures due to low energy, before or after a spinal injury.

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My spinal cord injury is due to an autoimmune disease.

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My cancer is currently active.

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I have been diagnosed with depression or anxiety based on specific questionnaires.

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I have osteoporosis and am on medication for it.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-11 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-11 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-11 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Six-Minute Walk Test

Secondary study objectives

Berg Balance Test

Electromyography

International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination

+9 more

Trial Design

2Treatment groups

Active Control

Group I: Transcutaneous spinal stimulation & Physical therapyActive Control2 Interventions

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

Group II: Physical therapy onlyActive Control1 Intervention

Physical therapy that targets rehabilitation of walking and standing functions

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,791 Previous Clinical Trials

1,905,496 Total Patients Enrolled

Media Library

Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03509558 — N/A

Spinal Cord Injury Research Study Groups: Transcutaneous spinal stimulation & Physical therapy, Physical therapy only

Spinal Cord Injury Clinical Trial 2023: Physical Therapy Highlights & Side Effects. Trial Name: NCT03509558 — N/A

Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03509558 — N/A

~0 spots leftby Sep 2024

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