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Spinal Cord Stimulation for Spinal Cord Injury

N/A

Recruiting

Led By Jill M Wecht, EdD

Research Sponsored by James J. Peters Veterans Affairs Medical Center

Eligibility Criteria Checklist

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

Must have

Prescription medications have not changed for at least 30 days

SCI between C3-T6

Must not have

History of moderate or severe head trauma (TBI) or diagnosed with cognitive impairment

Open wounds over the spine at the level targeted for stimulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during procedures (90 minutes)

Summary

This trial looks at how transcutaneous spinal cord stimulation affects exercise endurance & core body temp in people with chronic spinal cord injury. Participants will receive active & sham stimulation during exercise & in a cold room. No long-term benefits expected.

Who is the study for?

This trial is for adults over 18 with chronic spinal cord injury (SCI) between C3-T6, who have been injured for more than a year and haven't changed their meds in the last month. They should have previously participated in a related SCI study and not be pregnant or suffering from other neurological conditions, heart diseases, severe head trauma, psychological disorders, recent substance abuse, seizures, diabetes or untreated thyroid disease.

What is being tested?

The study tests if transcutaneous spinal cord stimulation (TSCS) can help people with cervical SCI endure moderate exercise longer and regulate body temperature better compared to sham stimulation. Participants will try both real and fake stimulations while exercising or being exposed to cold temperatures.

What are the potential side effects?

There are no long-term benefits expected from this study; however side effects are not detailed. Typically TSCS might cause discomfort at the stimulation site or skin irritation.

Eligibility Criteria

Inclusion Criteria

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

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My prescription medications have been the same for the last 30 days.

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My spinal cord injury is between my neck and upper back.

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I am over 18 years old.

Exclusion Criteria

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

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I have had a serious head injury or have been diagnosed with cognitive impairment.

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I have open wounds on my back where a device might be placed.

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I have a history of seizures.

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I have a history of heart or blood vessel disease.

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I have diabetes.

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I have a thyroid condition that hasn't been treated.

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I rely on a ventilator for breathing or have an open tracheostomy.

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I have a neurological condition other than spinal cord injury.

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I am currently not suffering from any acute illness or infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during procedures (90 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during procedures (90 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during procedures (90 minutes) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Exercise Endurance Time

Recovery Heart Rate

Tcore

+1 more

Secondary study objectives

Rate of Perceived Exhaustion

Workload

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Transcutaneous Spinal Cord StimulationExperimental Treatment1 Intervention

The transcutaneous spinal cord stimulation used in this experiment is specific to each participant as determined in a previous study. Possible parameters include biphasic or monophasic, Russian or Nonrussian, a variety of pulse widths, and location of stimulation (T7-8, T9-10,- T11-12, L1-2). The amplitude of the stimulation also depends on the results of the mapping study. This stimulation will be delivered 30 minutes at a time.

Group II: Sham Transcutaneous Spinal Cord StimulationPlacebo Group1 Intervention

The sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes.

0 / 12Eligibility criteria met