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Device

Spinal Stimulation for Spinal Cord Injury (SCI Trial)

N/A

Recruiting

Led By Gail F Forrest, PhD

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

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

Must have

Exhibits at least one of the following hypotensive symptoms: Baseline hypotension - resting supine or seated SBP < 90mmHg; SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position; Symptoms of orthostasis with a drop of SBP (<90mmHg) from supine to sitting.

Injury level ≥T2 (thoracic level)

Must not have

Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction

Ventilator-dependent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up will be performed every 5 minutes during the orthostatic tests, average of 2 weeks

Summary

This trial aims to evaluate if spinal stimulation can stabilize blood pressure and reduce symptoms of orthostatic hypotension in individuals with spinal cord injury.

Who is the study for?

This trial is for individuals with acute spinal cord injury (7-30 days post-injury) at or above the T2 level, who experience low blood pressure symptoms. They must have an AIS grade of A-C and not be on new cardiac meds within the last 5 days. Exclusions include current severe illness, pregnancy, mental incapacity to consent, cancer, ventilator dependence, history of stimulators or pacemakers/defibrillators.

What is being tested?

The study tests if transcutaneous spinal stimulation can stabilize blood pressure in acute SCI patients during orthostatic challenges (moving from lying down to sitting up). It compares 'optimal' stimulation settings against a 'sham' placebo-like treatment to see which is better at preventing drops in blood pressure.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site and possible skin irritation due to electrodes. Since it's a non-invasive procedure, serious side effects are unlikely but monitoring will occur for any unexpected reactions.

Eligibility Criteria

Inclusion Criteria

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

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I experience low blood pressure or symptoms when I stand up.

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My spinal cord injury is at or above the T2 level.

Exclusion Criteria

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

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I have not had a recent heart attack or serious heart disease.

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I rely on a machine to help me breathe.

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I am unable to understand and consent to the trial on my own.

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I currently have an illness or infection that could affect my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ will be performed every 5 minutes during the orthostatic tests, average of 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~will be performed every 5 minutes during the orthostatic tests, average of 2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and will be performed every 5 minutes during the orthostatic tests, average of 2 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Orthostatic symptoms when stimulation is applied

Optimal stimulation frequency

Optimal stimulation sites

+1 more

Secondary study objectives

Additional hemodynamic measure - diastolic blood pressure

Additional hemodynamic measure - heart rate

Electromyography (EMG) of leg muscles - muscle activation (analysis of mean and peak amplitudes)

+5 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Optimal stimulation (for a blood pressure response)Active Control3 Interventions

Stimulation will be applied during an orthostatic sit-up challenge, using the profile (stimulation site and parameters) that was chosen in the mapping sessions, for optimal modulation of systolic blood pressure.

Group II: Sham stimulationPlacebo Group3 Interventions

Sham stimulation will be applied during an orthostatic sit-up challenge. Sham stimulation will be delivered at a predetermined spinal location. Stimulation parameters, however, will be different from those chosen for the optimal stimulation, and sensation may be different as well.

0 / 6Eligibility criteria met