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Procedure

TSCS for Spinal Cord Injury Blood Pressure Control

N/A

Recruiting

Research Sponsored by Jill M. Wecht, Ed.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up acute inpatient rehabilitation following sci (up to 4 months)

Awards & highlights

Study Summary

This trial proposes a novel approach to stabilizing BP in people with acute traumatic SCI using Transcutaneous Spinal Cord Stimulation (TSCS). This could help prevent BP instability and make it easier for healthcare professionals to provide treatment.

Who is the study for?

This trial is for acute inpatients with a traumatic spinal cord injury (SCI) within one year of the injury, experiencing low blood pressure related issues. They must be at least 14 years old and admitted to Acute Inpatient Rehabilitation at Mount Sinai. Exclusions include heart disease, recent heart attack, cancer, certain implants like pacemakers or cochlear implants, open skin lesions near electrode sites, pregnancy, or inability to consent.Check my eligibility

What is being tested?

The trial tests Transcutaneous Spinal Cord Stimulation (TSCS), a non-drug method aimed at stabilizing blood pressure after SCI. It's designed as an alternative to epidural stimulation and can be quickly turned on/off and used alongside physical exercise. The goal is to create a standard treatment algorithm for clinical use.See study design

What are the potential side effects?

While specific side effects are not listed here, TSCS generally has fewer risks compared to invasive procedures like epidural SCS since it's non-pharmacological and applied externally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ acute inpatient rehabilitation following sci (up to 4 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~acute inpatient rehabilitation following sci (up to 4 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and acute inpatient rehabilitation following sci (up to 4 months) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

The efficacy (#1) of TSCS to improve autonomic control following acute SCI.

The safety (#1) of TSCS to improve autonomic control following acute SCI.

The safety (#2) of TSCS to improve autonomic control following acute SCI.

Secondary outcome measures

The efficacy (#2) of TSCS to improve autonomic control following acute SCI.

Trial Design

1Treatment groups

Experimental Treatment

Group I: transcutaneous spinal stimulationExperimental Treatment1 Intervention

Transcutaneous spinal cord stimulation (TSCS) protocol to stabilize seated systolic blood pressure in newly injured patients with spinal cord injury and to test the ability of TSCS to reduce the fall in blood pressure when these patients are moved from the supine to the seated position.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Jill M. Wecht, Ed.D.Lead Sponsor

Icahn School of Medicine at Mount SinaiOTHER

862 Previous Clinical Trials

525,576 Total Patients Enrolled

Thomas N Bryce, MDStudy DirectorIcahn School of Medicine at Mount Sinai

Frequently Asked Questions

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

Does this research involve participants below the age of 65?

"Based on the study's prerequisites, participants must be aged 14 or older and not exceed 100 years old."

Answered by AI

What are the criteria for eligibility to participate in this research trial?

"This study is recruiting 50 participants that have experienced a spinal cord injury and are aged between 14 to 100."

Answered by AI

Is enrollment currently open for this trial?

"Affirmative. Information hosted on clinicaltrials.gov suggests that this medical investigation, initially posted on January 1st 2022, is presently seeking volunteers. The study requires 50 applicants to be recruited from one site."

Answered by AI

How many individuals may partake in this research program?

"Affirmative. Clinicaltrials.gov's data points to this clinical trial actively searching for suitable candidates, which was initially posted on January 1st 2022 and last revised on August 17th 2023. The researchers are hoping to enrol 50 patients at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI

Jill M. Wecht, Ed.D. 2022. "Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06000592.

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