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Behavioural Intervention

Electrical Stimulation for Motor Neuron Disease

N/A

Waitlist Available

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

Must not have

Complete loss of sensation at the area of electrode placement

History of surgery with hardware in the lumbar or thoracic spine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot feel anything where the electrode is placed.

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I have had spine surgery with hardware in my back.

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I have a recent lower back problem.

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I have a history of seizures or have been diagnosed with epilepsy.

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I have had cancer in my mid or lower back.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Modified Ashworth Scale

Secondary study objectives

0-10 numeric rating scale

10-meter walk test (10MWT)

6 minute walk test (6MWT)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~240

0 / 7Eligibility criteria met