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Behavioural Intervention

Electrical Stimulation for Motor Neuron Disease

N/A

Recruiting

Led By Eduardo Locatelli, MD, MPH

Research Sponsored by Nova Southeastern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of primary lateral sclerosis by the treating neurologist

Ambulatory with or without an assistive device or orthotic

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial will study the effects of electrical stimulation on muscle spasms and walking in people with primary lateral sclerosis. Stimulation pads will be applied to the back and abdomen and current adjusted to the patient, then left for 30 minutes.

Who is the study for?

This trial is for individuals with primary lateral sclerosis who can walk, with or without help. They must not have a history of cancer or surgery in the spine, acute back issues, pregnancy, heart devices, significant cognitive impairment by their doctor's assessment, seizures/epilepsy, open wounds where electrodes go on the skin, or complete loss of sensation in that area.Check my eligibility

What is being tested?

The study tests if a 30-minute session of transcutaneous electrical stimulation applied to the back and abdomen can reduce muscle spasms and improve walking. It involves one clinic visit for physical exams and assessments before and after treatment plus a follow-up phone interview.See study design

What are the potential side effects?

Potential side effects may include discomfort at the electrode sites, temporary muscle twitching during stimulation, skin irritation from adhesive pads used to attach electrodes. Serious side effects are unlikely given it's non-invasive.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My neurologist diagnosed me with primary lateral sclerosis.

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I can walk by myself or with help from a device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Modified Ashworth Scale

Secondary outcome measures

0-10 numeric rating scale

10-meter walk test (10MWT)

6 minute walk test (6MWT)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcutaneous electrical stimulation to reduce spasticity in PLSExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous electrical stimulation

2013

N/A

~230

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nova Southeastern UniversityLead Sponsor

89 Previous Clinical Trials

11,635 Total Patients Enrolled

Eduardo Locatelli, MD, MPHPrincipal InvestigatorNova Southeastern University

Alan Boruch, DO, PhDPrincipal InvestigatorNortheast Regional Medical Center / A.T. Still University

Frequently Asked Questions

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

Does this research encompass seniors aged 80 years or older?

"This clinical trial has an age limit range of 18 to 90, meaning those that are eligible must within this cohort."

Answered by AI

Are there any vacancies for individuals to participate in this experiment?

"This clinical trial is currently enrolling volunteers, and the entry on clinicaltrials.gov was initially created on August 28th 2023 with updates made as recently as September 8th of that same year."

Answered by AI

Could I potentially qualify to participate in this medical trial?

"Entry into this trial is only open to patients with primary lateral sclerosis and between the ages of 18-90. The enrolment process requires 6 people total."

Answered by AI

How many participants are actively involved in this trial?

"Affirmative. The information posted on clinicaltrials.gov suggests that this trial is actively enrolling participants, having been first published on August 28th 2023 and last updated September 8th of the same year. A total of 6 patients need to be conscripted from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis

2023. "Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06012110.