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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

SCI Trial 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.

SCI Trial 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.

SCI Trial 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

SCI 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
173 Previous Clinical Trials
10,703 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project accommodate participants over sixty years of age?

"This medical trial has an age limit of 18-75 years old, as indicated by its eligibility criteria."

Answered by AI

Is it possible to register for this experiment at present?

"The clinicaltrials.gov database confirms that this trial, first posted on March 1st 2023 and edited February 2nd 2023, is no longer recruiting patients. Nonetheless, there are 1631 other trials enrolling participants at present."

Answered by AI

What are the ultimate aims of this clinical experiment?

"This medical trial aims to identify the most beneficial stimulation frequency over a 3 week period. Secondary measurements involve SCI-QOL questionnaires administered through computer adaptive testing, GRA for gauging patient perceptions of treatment effectiveness, and diastolic blood pressure readings conducted throughout the study."

Answered by AI

May I be included in the experiment?

"This medical trial requires an enrolment of 5 individuals aged between 18 and 75, all having suffered a spinal cord injury for more than 6 months. Eligibility also entails: Injury level at or above T6 (thoracic vertebra), American Spinal Injury Association Impairment Scale grades A-D, Baseline hypotension - resting supine/seated systolic BP < 90mmHg; Systolic blood pressure drop ≥ 20 mm Hg within 5 minutes of sitting up; Orthostatic symptoms with SBP (<90mmHg) decrease from lie-down to upright position."

Answered by AI

Who else is applying?

What site did they apply to?
James J. Peters VA Medical Center, Bronx, NY
Kessler Foundation
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
The Effect of Transcutaneous Stimulation on Blood Pressure in Spinal Cord Injury (SCI)
2023. "The Effect of Transcutaneous Stimulation on Blood Pressure in Spinal Cord Injury (SCI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05725499.
~3 spots leftby Apr 2025
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