Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis

NCT06012110 | Completed DMC FDA Device

• 1 other identifier: 2023-219-NSU
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Modified Ashworth Scale

  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 Outcomes (5)

• Deep Tendon Reflex Scale

  through study completion, an average of 1 year

• 10-meter walk test (10MWT)

  through study completion, an average of 1 year

• 6 minute walk test (6MWT)

  through study completion, an average of 1 year

• Tinetti Performance Oriented Mobility Assessment

  through study completion, an average of 1 year

• 0-10 numeric rating scale

  through study completion, an average of 1 year

Study Arms (1)

Transcutaneous electrical stimulation to reduce spasticity in PLS

EXPERIMENTAL

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

Interventions

Transcutaneous electrical stimulation DEVICE

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.

Transcutaneous electrical stimulation to reduce spasticity in PLS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

NSU Health Neuroscience Institute

Davie, Florida, 33328, United States

Location

Related Publications (7)

• Feldman EL, Goutman SA, Petri S, Mazzini L, Savelieff MG, Shaw PJ, Sobue G. Amyotrophic lateral sclerosis. Lancet. 2022 Oct 15;400(10360):1363-1380. doi: 10.1016/S0140-6736(22)01272-7. Epub 2022 Sep 15.

  PMID: 36116464 BACKGROUND

• Nashold BS Jr, Friedman H. Dorsal column stimulation for control of pain. Preliminary report on 30 patients. J Neurosurg. 1972 May;36(5):590-7. doi: 10.3171/jns.1972.36.5.0590. No abstract available.

  PMID: 5026545 BACKGROUND

• Cook AW, Weinstein SP. Chronic dorsal column stimulation in multiple sclerosis. Preliminary report. N Y State J Med. 1973 Dec 15;73(24):2868-72. No abstract available.

  PMID: 4543587 BACKGROUND

• Lin A, Shaaya E, Calvert JS, Parker SR, Borton DA, Fridley JS. A Review of Functional Restoration From Spinal Cord Stimulation in Patients With Spinal Cord Injury. Neurospine. 2022 Sep;19(3):703-734. doi: 10.14245/ns.2244652.326. Epub 2022 Sep 30.

  PMID: 36203296 BACKGROUND

• Hofstoetter US, Freundl B, Danner SM, Krenn MJ, Mayr W, Binder H, Minassian K. Transcutaneous Spinal Cord Stimulation Induces Temporary Attenuation of Spasticity in Individuals with Spinal Cord Injury. J Neurotrauma. 2020 Feb 1;37(3):481-493. doi: 10.1089/neu.2019.6588. Epub 2019 Aug 9.

  PMID: 31333064 BACKGROUND

• Hofstoetter US, Freundl B, Lackner P, Binder H. Transcutaneous Spinal Cord Stimulation Enhances Walking Performance and Reduces Spasticity in Individuals with Multiple Sclerosis. Brain Sci. 2021 Apr 8;11(4):472. doi: 10.3390/brainsci11040472.

  PMID: 33917893 BACKGROUND

• Turner MR, Barohn RJ, Corcia P, Fink JK, Harms MB, Kiernan MC, Ravits J, Silani V, Simmons Z, Statland J, van den Berg LH; Delegates of the 2nd International PLS Conference; Mitsumoto H. Primary lateral sclerosis: consensus diagnostic criteria. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):373-377. doi: 10.1136/jnnp-2019-322541. Epub 2020 Feb 6.

  PMID: 32029539 BACKGROUND

Related Links

• Link to electrical stimulator utilized in this study

MeSH Terms

Conditions

Motor Neuron Disease

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Eduardo Locatelli, MD, MPH

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

• Alan Boruch, DO, PhD

  Northeast Regional Medical Center / A.T. Still University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 25, 2023
• Study Start: August 28, 2023
• Primary Completion: August 21, 2024
• Study Completion: August 22, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)