Spinal Stimulation for Cardiovascular Function After Spinal Cord Injury

West Orange, NJ

N/A

Waitlist Available

Led By Einat Engel-Haber, MD

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

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

Must have

Injury level ≥ T6 (a cervical or a high-level chest injury)

Individuals experiencing low blood pressure after the injury

Must not have

Significant disease affecting the blood vessels or signals in the heart, or a recent heart attack (myocardial infarction) has occurred

New medication prescribed to treat blood pressure or a heart problem within the last five days (excluding midodrine)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how the cardiovascular system changes in the first year after a spinal cord injury and how treatments like spinal stimulation through the skin can affect blood pressure. The study will involve about 20

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Who is the study for?

This trial is for individuals in their first year after a spinal cord injury who are experiencing low blood pressure and related cardiovascular issues. Participants will undergo treatment sessions during and after their stay at the Kessler Institute for Rehabilitation.Check my eligibility

What is being tested?

The study tests how transcutaneous spinal stimulation affects blood pressure and overall cardiovascular function post-spinal cord injury. It involves around 20-29 treatment sessions over the course of a year, both inpatient and outpatient.

What are the potential side effects?

Potential side effects may include skin irritation or discomfort at the site of electrical nerve stimulation, as well as possible changes to heart rate or blood pressure during treatments.

Eligibility Criteria

Inclusion Criteria

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

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My spinal injury is at chest level or higher.

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I have low blood pressure following an injury.

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I am between 18 and 75 years old.

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Exclusion Criteria

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

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I have serious heart or blood vessel problems, or had a recent heart attack.

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I was prescribed a new heart or blood pressure medication, not including midodrine, in the last 5 days.

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I have had seizures in the past.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month. for reporting.