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Spinal Stimulation for Spinal Cord Injury (SCI Trial)

Q: Is enrollment for this experiment restricted to individuals of a certain age?

In order to be included in this trial, the patient must meet a minimum age requirement of 18 and may not exceed 75 years old.

Q: Is enrollment for this experiment open at the moment?

As reported on clinicaltrials.gov, the recruitment period for this study has concluded. It was first posted on April 1st 2023 and last edited on February 8th 2023; however, 1639 other trials are still suitable options for prospective participants.

Q: What is the aim of this trial?

The primary purpose of this trial, measured over a two-week period, is to determine the ideal frequency for stimulation. Additionally, skin integrity (skin irritation or breakdown caused by electrodes, wires or adhesive tape) will be monitored daily and adverse effects recorded in order to gauge safety. Moreover, feasibility metrics such as compliance ratio and session duration are also being tracked throughout the study.

Q: Who meets the criteria to be eligible for participation in this experiment?

This clinical trial is open to 12 individuals who have recently sustained a <a href="https://www.withpower.com/clinical-trials/spinal-cord-injury">spinal cord injury</a> and are between the ages of 18-75. Additionally, patients must meet these criteria: 7-30 days since their incident, an Injury level ≥ T2 on Thoracic Scale, AIS grades of A-C impairment scale; Baseline hypotension - resting supine or seated SBP &#x3C; 90mmHg; Systolic Blood Pressure (SBP) drop by 20 mmHg within 5 minutes in a seated position; Symptoms of orthostasis with a fall in SBP (&#x3C;90mmHg) from standing to sitting.

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)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

SCI Trial 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.Check my eligibility

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.See study design

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.

SCI Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

SCI Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Orthostatic symptoms when stimulation is applied

Optimal stimulation frequency

Optimal stimulation sites

+1 more

Secondary outcome measures

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

SCI 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 / 2Eligibility criteria met

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Who is running the clinical trial?

Kessler FoundationLead Sponsor

174 Previous Clinical Trials

10,726 Total Patients Enrolled

Gail F Forrest, PhDPrincipal InvestigatorKessler Foundation

3 Previous Clinical Trials

105 Total Patients Enrolled

Media Library

Biostim-5 transcutaneous spinal stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05731986 — N/A

Traumatic Brain Injury Research Study Groups: Optimal stimulation (for a blood pressure response), Sham stimulation

Traumatic Brain Injury Clinical Trial 2023: Biostim-5 transcutaneous spinal stimulation Highlights & Side Effects. Trial Name: NCT05731986 — N/A

Biostim-5 transcutaneous spinal stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05731986 — N/A

Frequently Asked Questions

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

Is enrollment for this experiment restricted to individuals of a certain age?

"In order to be included in this trial, the patient must meet a minimum age requirement of 18 and may not exceed 75 years old."

Answered by AI

Is enrollment for this experiment open at the moment?

"As reported on clinicaltrials.gov, the recruitment period for this study has concluded. It was first posted on April 1st 2023 and last edited on February 8th 2023; however, 1639 other trials are still suitable options for prospective participants."

Answered by AI

What is the aim of this trial?

"The primary purpose of this trial, measured over a two-week period, is to determine the ideal frequency for stimulation. Additionally, skin integrity (skin irritation or breakdown caused by electrodes, wires or adhesive tape) will be monitored daily and adverse effects recorded in order to gauge safety. Moreover, feasibility metrics such as compliance ratio and session duration are also being tracked throughout the study."

Answered by AI

Who meets the criteria to be eligible for participation in this experiment?

"This clinical trial is open to 12 individuals who have recently sustained a spinal cord injury and are between the ages of 18-75. Additionally, patients must meet these criteria: 7-30 days since their incident, an Injury level ≥ T2 on Thoracic Scale, AIS grades of A-C impairment scale; Baseline hypotension - resting supine or seated SBP < 90mmHg; Systolic Blood Pressure (SBP) drop by 20 mmHg within 5 minutes in a seated position; Symptoms of orthostasis with a fall in SBP (<90mmHg) from standing to sitting."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI)

2023. "Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05731986.

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