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Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis
Sponsor: Nova Southeastern University
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.
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2023-08-28
Completion Date
2024-08-22
Last Updated
2026-08-25
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
NSU Health Neuroscience Institute
Davie, Florida, United States