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TSCS for Spinal Cord Injury

N/A
Recruiting
Led By Jill Wecht, EdD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have reached the age of 18, have sustained a SCI with temporary or permanent loss of sensory and/or motor function, and have been admitted to an spinal cord injury (SCI) Acute Inpatient Rehabilitation (AIR) unit within MSHS within one year of injury.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly until discharge, average of 3 weeks
Awards & highlights

Study Summary

This trial will focus on using a novel approach, transcutaneous spinal cord stimulation, to stabilize blood pressure for people with acute spinal cord injuries during their inpatient rehabilitation.

Who is the study for?
This trial is for adults over 18 who've had a spinal cord injury (SCI) within the last year and are in acute inpatient rehab. They should have unstable blood pressure due to their SCI, but can't join if they're pregnant, lack mental capacity for consent, have certain implants or heart issues, open skin lesions where electrodes go, or recent heart attacks.Check my eligibility
What is being tested?
The study tests Transcutaneous Spinal Cord Stimulation (TSCS) as a way to stabilize blood pressure during early rehab after an SCI. It aims to find the best settings for TSCS that work well with physical exercises without adding more drugs into patients' routines.See study design
What are the potential side effects?
While specific side effects of TSCS aren't detailed here, similar non-invasive stimulation methods may cause discomfort at the electrode sites or temporary skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18, had a spinal cord injury within the last year, and am in a special rehab program.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly until discharge, average of 3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly until discharge, average of 3 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
Forced Vital Capacity (FVC) With Simulation
Forced Vital Capacity (FVC) Without Simulation
Severity of Dizziness Scale
+3 more
Secondary outcome measures
Autonomic Dysreflexia (AD) Symptoms Survey
International SCI Pain Basic Data Set (ISCIPBDS)
Lower Extremity Muscle Strength (LEMS) Testing
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Acute Inpatients With Spinal Cord InjuryExperimental Treatment2 Interventions
Inpatient participants undergoing rehabilitation after acute traumatic SCI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous spinal cord stimulation
2019
N/A
~40

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
853 Previous Clinical Trials
535,883 Total Patients Enrolled
James J. Peters Veterans Affairs Medical CenterFED
55 Previous Clinical Trials
2,838 Total Patients Enrolled
Jill Wecht, EdDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
5 Previous Clinical Trials
187 Total Patients Enrolled

Media Library

Transcutaneous spinal cord stimulation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05305118 — N/A
Spinal Cord Injury Research Study Groups: Acute Inpatients With Spinal Cord Injury
Spinal Cord Injury Clinical Trial 2023: Transcutaneous spinal cord stimulation Highlights & Side Effects. Trial Name: NCT05305118 — N/A
Transcutaneous spinal cord stimulation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05305118 — N/A

Frequently Asked Questions

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

Are participants still being accepted for this clinical research?

"The clinicaltrials.gov registry demonstrates that this trial is not presently recruiting participants, despite its initial posting on March 1st 2022 and most recent update occurring on the 22nd of same month. However, there are currently 556 other studies looking for volunteers to join their ranks."

Answered by AI

What are the key aims of this experiment?

"The primary outcome of this trial, measured for an average duration of three weeks prior to discharge, is the Sit-Up Test - Cerebral Blood Flow velocity (CBFv) with and without stimulation. Secondary objectives encompass Autonomic Dysreflexia Symptoms Survey rating from 0-10 which assesses symptoms experienced in the past week; Pain Numeric Rating Scale ranging from 0-10 which determines severity of pain; and Spinal cord injury Pain Instrument comprised of four items that determine if new pain stems from a neuropathic etiology."

Answered by AI

Could individuals aged twenty or more be enrolled in this research project?

"This clinical trial is looking to recruit applicants aged between 18 and 89. The study also has 49 sub-trials for minors, as well as 470 trials designed specifically for people over 65 years of age."

Answered by AI

What criteria must potential participants meet to join this experiment?

"To be accepted into this clinical trial, patients must have hypotension and be between 18 to 89 years of age. There is currently a need for around 50 participants."

Answered by AI
~24 spots leftby Mar 2026