Participants with a chronic SCI (≥ 6 months after injury) for Spinal Cord Injury

Phase-Based Progress Estimates
Kessler Foundation, West Orange, NJSpinal Cord Injury+8 MoreBiostim-5 transcutaneous spinal stimulator - Device
18 - 75
All Sexes
What conditions do you have?

Study 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.

Eligible Conditions
  • Spinal Cord Injury
  • Low Blood Pressure
  • Orthostatic Hypotension
  • Spinal Cord Disease
  • Cardiovascular Disease
  • Traumatic Brain Injury (TBI)
  • Central Nervous System Disorders
  • Nervous System Disorders
  • High Blood Pressure

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 5 Secondary · Reporting Duration: post training, average of 6 weeks

Week 6
Spinal Cord Injury-Quality of Life (SCI-QOL) questionnaires
Week 2
Systolic blood pressure - effect of training
Week 3
EMG of leg muscles - muscle activation (analysis of mean and peak amplitudes)
Optimal stimulation frequency
Optimal stimulation sites
Week 6
Orthostatic symptoms questionnaire
Systolic blood pressure - efficacy of stimulation
Week 6
Global response assessment (GRA)
Week 6
Additional hemodynamic measure - diastolic blood pressure
Additional hemodynamic measure - heart rate

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Participants with a chronic SCI (≥ 6 months after injury)
1 of 1

Experimental Treatment

5 Total Participants · 1 Treatment Group

Primary Treatment: Participants with a chronic SCI (≥ 6 months after injury) · No Placebo Group · N/A

Participants with a chronic SCI (≥ 6 months after injury)Experimental Group · 2 Interventions: Biostim-5 transcutaneous spinal stimulator, Tilt-table orthostatic stress testing · Intervention Types: Device, DiagnosticTest

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: post training, average of 6 weeks

Who is running the clinical trial?

Kessler FoundationLead Sponsor
159 Previous Clinical Trials
10,340 Total Patients Enrolled
Gail F Forrest, PhdPrincipal InvestigatorKessler Foundation

Eligibility Criteria

Age 18 - 75 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a spinal cord injury for at least 6 months.
You have at least one of the following symptoms of low blood pressure:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

Is it possible to register for this experiment at present?

"The 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.