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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

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.Check my eligibility
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.See study design
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
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You have a spinal cord injury classified as AIS A, B, C, or D according to the ASIA Impairment Scale.
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I have had a spinal cord injury for at least 6 months.
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My spinal cord injury is at or above the T6 level.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Optimal stimulation frequency
Optimal stimulation sites
Orthostatic symptoms questionnaire
+2 more
Secondary outcome measures
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

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)

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor
175 Previous Clinical Trials
10,753 Total Patients Enrolled
Gail F Forrest, PhdPrincipal InvestigatorKessler Foundation

Media Library

Biostim-5 transcutaneous spinal stimulator (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05725499 — N/A
Nervous System Disorders Research Study Groups: Participants with a chronic SCI (≥ 6 months after injury)
Nervous System Disorders Clinical Trial 2023: Biostim-5 transcutaneous spinal stimulator Highlights & Side Effects. Trial Name: NCT05725499 — N/A
Biostim-5 transcutaneous spinal stimulator (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05725499 — N/A
~2 spots leftby Jul 2025
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