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Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis

NCT06012110 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-09-04

No results posted yet for this study

Summary

The goal of this clinical trial is to determine if non-invasive electrical stimulation, using an electric stimulator placed on the skin of the patients back and abdomen for 30 minutes can reduce muscle spasms (spasticity) and improve walking function in patients with primary lateral sclerosis. Participants will attend one in-person clinic visit and participate in one telephone interview 24 hours after the treatment. The clinic visit will include pre-intervention, treatment and post-intervention assessments. The assessments will consist of a complete physical exam by the clinic neurologist followed by assessments and scoring of spasticity, deep tendon reflexes, gait quality, gait speed, gait endurance and balance. Patient's will rate their perceived spasticity pre, immediately post and 24 hours post treatment.

The treatment involves one 30-minute electrical stimulation session, which includes application of electrode pads to the patients back and abdomen. The patient will lay supine (on their back) with a pillow placed under their knees for comfort. The pads will then be connected to an FDA approved electrical stimulator. The electrical stimulator will be turned on and current adjusted to the individual patient based on small muscle contractions in their legs. Once the current is set, the patient will lay supine for 30 minutes. After 30 minutes, the device will be turned off and electrode pads removed.

Conditions

  • Primary Lateral Sclerosis

Interventions

DEVICE

Transcutaneous electrical stimulation

While participants are supine with a pillow placed below the knees for comfort, one 30-minute transcutaneous electrical stimulation session will be performed at a frequency of 50 Hz, pulse width of 400 microseconds and individualized amplitude will be completed.

Sponsors & Collaborators

  • Nova Southeastern University

    lead OTHER

Principal Investigators

  • Eduardo Locatelli, MD, MPH · Nova Southeastern University

  • Alan Boruch, DO, PhD · Northeast Regional Medical Center / A.T. Still University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-28
Primary Completion
2024-08-21
Completion
2024-08-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06012110 on ClinicalTrials.gov