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Electrical Neuromodulation

Electrical Neuromodulation for Spasticity

N/A
Recruiting
Led By Matthias J Krenn, PhD
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
History of SCI (ASIA Impairment Scale grades A-D)
The presence of at least mild spasticity (>3) in the lower limbs by self-report of the Numerical Rating Scale (from 0 to 10) of spasticity severity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after one week
Awards & highlights

Study Summary

This trial will test the efficacy of four different transcutaneous spinal stimulation (TSS) protocols on spasticity in people with chronic spinal cord injury (SCI). TSS is a non-pharmacological approach that uses electrical stimulation to modulate the excitability of the lumbosacral network. This trial will use a prospective, experimental, cross-over, assessor-masked study design in 12 individuals with chronic SCI. The study will examine the effect of TSS on spasticity on a short- and long-term basis.

Who is the study for?
This trial is for adults over 18 with chronic spinal cord injury (SCI) who experience mild to severe spasticity in their lower limbs. Candidates should be at least six months post-injury and able to follow instructions, with no ongoing infections, pregnancy, or implanted devices that could interfere with the treatment.Check my eligibility
What is being tested?
The study tests four different protocols of transcutaneous spinal stimulation (TSS), a non-drug electrical neuromodulation therapy aimed at reducing muscle spasms caused by SCI. It's an experimental cross-over trial where participants will try each TSS protocol both immediately and as part of a home-based therapy routine.See study design
What are the potential side effects?
Potential side effects may include discomfort or skin irritation where electrodes are placed, temporary increase in muscle tone or spasms during adjustment to the treatment, and possible fatigue due to daily sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a spinal cord injury graded A-D.
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I experience mild or greater leg spasticity, rating it above 3 out of 10.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after one week
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after one week 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 flexion withdrawal reflex root-mean-square
Change in flexion withdrawal reflex root-mean-square (during intervention)
Change in pendulum test index
+3 more
Secondary outcome measures
Change in Modified Ashworth Scale
Change in Modified Ashworth Scale (after one week)
Change in Penn Spasm Frequency Scale
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Neuromodulation with 50 Hz and low intensityExperimental Treatment1 Intervention
Transcutaneous spinal stimulation for 30 min with a stimulation frequency of 50 Hz and stimulation intensity of 0.45 x lowest motor threshold (reflex threshold in leg muscles).
Group II: Neuromodulation with 50 Hz and high intensityExperimental Treatment1 Intervention
Transcutaneous spinal stimulation for 30 min with a stimulation frequency of 50 Hz and stimulation intensity of 0.90 x lowest motor threshold (reflex threshold in leg muscles).
Group III: Neuromodulation with 100 Hz and low intensityExperimental Treatment1 Intervention
Transcutaneous spinal stimulation for 30 min with a stimulation frequency of 100 Hz and stimulation intensity of 0.45 x lowest motor threshold (reflex threshold in leg muscles).
Group IV: Neuromodulation with 100 Hz and high intensityExperimental Treatment1 Intervention
Transcutaneous spinal stimulation for 30 min with a stimulation frequency of 100 Hz and stimulation intensity of 0.90 x lowest motor threshold (reflex threshold in leg muscles).

Find a Location

Who is running the clinical trial?

Methodist Rehabilitation CenterOTHER
6 Previous Clinical Trials
162 Total Patients Enrolled
University of Mississippi Medical CenterLead Sponsor
173 Previous Clinical Trials
195,075 Total Patients Enrolled
Matthias J Krenn, PhDPrincipal InvestigatorUniversity of Mississippi Medical Center

Media Library

Electrical neuromodulation (Electrical Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05457205 — N/A
Spinal Cord Injury Research Study Groups: Neuromodulation with 50 Hz and low intensity, Neuromodulation with 50 Hz and high intensity, Neuromodulation with 100 Hz and low intensity, Neuromodulation with 100 Hz and high intensity
Spinal Cord Injury Clinical Trial 2023: Electrical neuromodulation Highlights & Side Effects. Trial Name: NCT05457205 — N/A
Electrical neuromodulation (Electrical Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05457205 — N/A

Frequently Asked Questions

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

Are there still available opportunities to partake in this trial?

"The trial is currently seeking participants. According to its listing on clinicaltrials.gov, it was established in August 16th 2022 and last amended three days later."

Answered by AI

How many participants have signed up for this research endeavor?

"Affirmative. According to the information available on clinicaltrials.gov, this medical trial first appeared on August 16th 2022 and was recently updated on the 19th of that month. The study is recruiting 12 people from two different facilities for participation."

Answered by AI

What are the key purposes of this research initiative?

"The primary aim of this study, which will be evaluated within a Before and after an intervention session (30 minutes) time frame is to ascertain any Changes in posterior root reflex amplitude following the administration of the treatment. Additionally, secondary outcomes such as modifications to Spinal cord Assessment Tool for Spastic Reflexes (summed 4-point scale encompassing ankle clonus, flexor & extensor leg spasms), Modified Ashworth Scale (a 0 - 40 score range gauging muscle tone across 10 tested muscles with '1+' scoring category valued at 1.5) and Modified Ashworth Scale post one week shall also be monitored."

Answered by AI

Who else is applying?

What site did they apply to?
Methodist Rehabilitation Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
What state do they live in?
Wisconsin
Recent research and studies
clinicaltrials.govStudy
Transcutaneous Spinal Stimulation for Lower Limb Spasticity in Spinal Cord Injury
Matthias J. Krenn, PhD 2022. "Transcutaneous Spinal Stimulation for Lower Limb Spasticity in Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05457205.
~4 spots leftby Feb 2025
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