Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis

September 8, 2023 updated by: Nova Southeastern University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objective: The primary aim of this preliminary pilot study is to assess the clinical effects of transcutaneous electrical stimulation (tES) in reducing spasticity in the lower extremities and increasing mobility in patients with Primary Lateral Sclerosis (PLS).

Study population: 6 patients with a confirmed diagnosis of PLS aged 18-90

Design:

Each enrolled participant will attend one in-person clinic visit and participate in one telephone interview 24 hours post-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. The patients will rate their perceived spasticity pre, immediately post and 24 hours post treatment.

Treatment will include a 30-minute transcutaneous electrical stimulation (tES) session where tES will be applied through two sets of electrodes positioned adjacent to the T11/T12 spinous processes and a second pair of electrodes placed para-umbilically on the lower abdomen. A current-controlled electrical stimulator will be used to deliver charge-balanced symmetrical, biphasic rectangular pulses to the paraspinal electrodes as the anode for the first phase and as the cathode for the second phase of the stimulation phase.

Electrode placement will be verified by applying electrical stimulation to elicit mild posterior root-muscle (PRM) contractions in the L2-S2 innervated rectus femoris, biceps femoris, tibialis anterior, and triceps surae muscle group bilaterally with the participants relaxed in the supine position. This will be determined by palpation at the patellar and achilles tendons of both sides. While the participants remain supine, the stimulator will be set to continuous mode to deliver stimulation at a frequency of 50 Hz and pulse width of 400 microseconds, then the stimulation amplitude will be slowly increased from 0 milliamp (mA) to an amplitude that may generate minor paraesthesias (slight tingling sensations) in some individuals in the bilateral L2-S2 lower extremity dermatomes but below the level that elicited posterior motor root (PMR) contraction responses. The stimulation amplitude will be individually assessed and set for each participant, and the stimulation amplitude upper limit will be no more than 90% of the lowest PRM response for each participant. After this 30-minute tES session, the tES unit will be turned off, the electrodes removed, and the participants assessed.

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Davie, Florida, United States, 33328
        • Recruiting
        • NSU Health Neuroscience Institute
        • Contact:
          • Nikole Lesmes-Rincon
          • Phone Number: 954-262-6387
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of primary lateral sclerosis by the treating neurologist
  • Ambulatory with or without a assistive device or orthotic

Exclusion Criteria:

  • History of cancer in the lumbar or thoracic spine
  • History of surgery with hardware in the lumbar or thoracic spine
  • Acute lower back pathology
  • Current pregnancy
  • History of implantable cardiac device
  • Diagnosis of significant cognitive impairment by the treating physician
  • History of seizures or diagnosis of epilepsy
  • Open wound at location of electrodes
  • Complete loss of sensation at the area of electrode placement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous electrical stimulation to reduce spasticity in PLS
Primary lateral sclerosis (PLS) is a progressive upper motor neuron neurodegenerative disorder. A hallmark of PLS is a presentation with lower extremity stiffness and spasticity as well as bulbar involvement. The investigators will be performing a preliminary study designed to assess transcutaneous electrical stimulation (tES), a non-pharmacological and non-invasive modality used in spinal cord injury and multiple sclerosis patients, as a treatment for reducing spasticity in the lower extremities and increasing mobility in patients with PLS.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale
Time Frame: through study completion, an average of 1 year
6 category ordinal scale (minimum value = 0 maximum value = 4) that measures spasticity where higher scores indicate greater spasticity
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deep Tendon Reflex Scale
Time Frame: through study completion, an average of 1 year
5 point ordinal scale recorded as a number from 0-4 where 2 is normal and any number above or below this is abnormal.
through study completion, an average of 1 year
10-meter walk test (10MWT)
Time Frame: through study completion, an average of 1 year
The 10MWT measures gait speed where the time it takes patient to cover a distance of 6 meters is recorded in m/s.
through study completion, an average of 1 year
6 minute walk test (6MWT)
Time Frame: through study completion, an average of 1 year
The 6MWT assesses overall gait function and endurance. The total distance travelled in 6 minutes is recorded in feet.
through study completion, an average of 1 year
0-10 numeric rating scale
Time Frame: through study completion, an average of 1 year
Patients will self rate their spasticity on a scale of 0-10 with 0 = no spasticity and 10 = worst possible spasticity.
through study completion, an average of 1 year
Tinetti Performance Oriented Mobility Assessment
Time Frame: through study completion, an average of 1 year
3 point ordinal scale that ranges from 0-2 with a total possible score of 28 that measures gait quality and balance. Higher scores indicate improved gait and balance.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Southeastern University

Investigators

  • Principal Investigator: Eduardo Locatelli, MD, MPH, Nova Southeastern University
  • Principal Investigator: Alan Boruch, DO, PhD, Northeast Regional Medical Center / A.T. Still University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-219-NSU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study will provide pilot data to establish a larger, more robust study. The data will be kept internally.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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