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Neuromodulation

Transcutaneous spinal stimulation at 100 Hz for Spinal Cord Injury

Q: Is the enrollment for participants currently open in this clinical trial?

<p>According to details on clinicaltrials.gov, patient recruitment for this particular trial has concluded. The initial posting date was 1st of March in the year 2024 and the most recent edit occurred on 21st of February that same year. Despite this specific study reaching its target, there are currently 953 other trials actively enrolling participants at present.</p>

Phase < 1

Waitlist Available

Led By Matthias J Krenn, Ph.D.

Research Sponsored by University of Mississippi Medical Center

Eligibility Criteria Checklist

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

Must have

Age 18 years or older

History of spinal cord injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at post-intervention (100 minutes)

Awards & highlights

Study Summary

This trial is looking at how transcutaneous spinal stimulation can help people with muscle spasms and stiffness due to spinal cord injuries. The stimulation uses electrical currents on the skin over the spine to improve muscle

Who is the study for?

This trial is for individuals with spinal cord injuries experiencing muscle spasms and stiffness. Participants should be adults who have had a stable injury for at least six months. Specific criteria about the severity of the injury or other health conditions are not provided.Check my eligibility

What is being tested?

The study tests transcutaneous spinal stimulation at different pulse rates (50 Hz, 100 Hz) and compares it to sham stimulation and common muscle relaxants (baclofen, tizanidine). The goal is to see if this non-invasive method can reduce muscle problems caused by spinal cord injuries.See study design

What are the potential side effects?

Potential side effects may include discomfort or skin irritation where the electrical currents are applied. Muscle relaxants like baclofen and tizanidine could cause drowsiness, weakness, or dizziness.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have had a spinal cord injury in the past.

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I experience significant stiffness in my legs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at post-intervention (100 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and at post-intervention (100 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at post-intervention (100 minutes) 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 from baseline in muscle stiffness as measured by the Modified Ashworth Scale (MAS)

Change from baseline in spasms as measured by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS).

Secondary outcome measures

Change from baseline of flexion withdrawal reflex (FWR) response amplitude.

Change from baseline of posterior root reflexes (PRRs) recruitment curves.

Change from baseline of stretch reflex (SR) response amplitude.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcutaneous spinal stimulation in combination of baclofen/tizanidine/placeboExperimental Treatment5 Interventions

Each participant will receive five distinct interventions: Transcutaneous spinal stimulation at 100 Hz for 30 minutes with a placebo Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a placebo Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a single-dose baclofen Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a single-dose tizanidine Transcutaneous spinal stimulation (sham) for 30 minutes with a placebo

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Mississippi Medical CenterLead Sponsor

173 Previous Clinical Trials

195,071 Total Patients Enrolled

Methodist Rehabilitation CenterOTHER

6 Previous Clinical Trials

158 Total Patients Enrolled

The Craig H. Neilsen FoundationOTHER

55 Previous Clinical Trials

2,919 Total Patients Enrolled

Frequently Asked Questions

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

Is the enrollment for participants currently open in this clinical trial?

"According to details on clinicaltrials.gov, patient recruitment for this particular trial has concluded. The initial posting date was 1st of March in the year 2024 and the most recent edit occurred on 21st of February that same year. Despite this specific study reaching its target, there are currently 953 other trials actively enrolling participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury

Matthias J. Krenn, PhD 2024. "Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06274021.