← Back to Search

Behavioural Intervention

Transcutaneous Spinal Stimulation for Blood Pressure Control in 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

American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-D

Spinal cord injury for greater than or equal to 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post training, average of 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates if stimulating the spinal cord can improve blood pressure stability in those with spinal cord injuries. Participants will be tested in various positions with and without stimulation to see the effects.

Who is the study for?

This trial is for individuals with chronic spinal cord injury (SCI) who've had it for at least 6 months, have an injury level at or above T6, and experience low blood pressure symptoms. They must be able to consent and not be pregnant, ventilator-dependent, or have certain heart conditions or other medical devices implanted.

What is being tested?

The study tests if a Biostim-5 transcutaneous spinal stimulator can stabilize blood pressure in SCI patients during tilt-table tests. It explores the best stimulation sites and parameters to normalize blood pressure when changing positions from lying down to upright.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, skin irritation from electrodes, dizziness during orthostatic testing, muscle spasms due to stimulation, and temporary changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

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

Select...

You have a spinal cord injury classified as AIS A, B, C, or D according to the ASIA Impairment Scale.

Select...

I have had a spinal cord injury for at least 6 months.

Select...

My spinal cord injury is at or above the T6 level.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post training, average of 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post training, average of 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and post training, average of 6 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

Optimal stimulation frequency

Optimal stimulation sites

Orthostatic symptoms questionnaire

+2 more

Secondary study objectives

Additional hemodynamic measure - diastolic blood pressure

Additional hemodynamic measure - heart rate

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

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with a chronic SCI (≥ 6 months after injury)Experimental Treatment2 Interventions

Participants will complete three days of baseline assessments (including a baseline orthostatic test and a day of neurophysiological mapping), five days of stimulation mapping to locate the optimal spinal sites for a blood pressure response, a day of testing with stimulation applied during an orthostatic provocation and a two-week (total of six days) training period with repeated exposure to stimulation, followed by two days of additional orthostatic tests (with and without stimulation)

0 / 3Eligibility criteria met