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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
Must not have
Skin conditions precluding placement of electrodes
Passive implants (plates, screws) between T10 and L3 vertebras
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after one week
Awards & highlights

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have electrodes placed on my skin due to skin conditions.
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I have implants like plates or screws between my T10 and L3 vertebrae.
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I currently have an infection.
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I suspect my spinal condition is getting worse.
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My spinal cord injury is below the T11 vertebra.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after an intervention session (30 minutes)
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after an intervention session (30 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
179 Previous Clinical Trials
196,709 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 high intensity, Neuromodulation with 50 Hz and low 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
~2 spots leftby Feb 2025
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