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Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis

Primary Purpose

Primary Lateral Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous electrical stimulation
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Lateral Sclerosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NSU Health Neuroscience InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcutaneous electrical stimulation to reduce spasticity in PLS

Arm Description

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.

Outcomes

Primary Outcome Measures

Modified Ashworth Scale
6 category ordinal scale (minimum value = 0 maximum value = 4) that measures spasticity where higher scores indicate greater spasticity

Secondary Outcome Measures

Deep Tendon Reflex Scale
5 point ordinal scale recorded as a number from 0-4 where 2 is normal and any number above or below this is abnormal.
10-meter walk test (10MWT)
The 10MWT measures gait speed where the time it takes patient to cover a distance of 6 meters is recorded in m/s.
6 minute walk test (6MWT)
The 6MWT assesses overall gait function and endurance. The total distance travelled in 6 minutes is recorded in feet.
Tinetti Performance Oriented Mobility Assessment
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.
0-10 numeric rating scale
Patients will self rate their spasticity on a scale of 0-10 with 0 = no spasticity and 10 = worst possible spasticity.

Full Information

First Posted
August 14, 2023
Last Updated
September 8, 2023
Sponsor
Nova Southeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT06012110
Brief Title
Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis
Official Title
Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Southeastern University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Lateral Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous electrical stimulation to reduce spasticity in PLS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Ashworth Scale
Description
6 category ordinal scale (minimum value = 0 maximum value = 4) that measures spasticity where higher scores indicate greater spasticity
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Deep Tendon Reflex Scale
Description
5 point ordinal scale recorded as a number from 0-4 where 2 is normal and any number above or below this is abnormal.
Time Frame
through study completion, an average of 1 year
Title
10-meter walk test (10MWT)
Description
The 10MWT measures gait speed where the time it takes patient to cover a distance of 6 meters is recorded in m/s.
Time Frame
through study completion, an average of 1 year
Title
6 minute walk test (6MWT)
Description
The 6MWT assesses overall gait function and endurance. The total distance travelled in 6 minutes is recorded in feet.
Time Frame
through study completion, an average of 1 year
Title
Tinetti Performance Oriented Mobility Assessment
Description
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.
Time Frame
through study completion, an average of 1 year
Title
0-10 numeric rating scale
Description
Patients will self rate their spasticity on a scale of 0-10 with 0 = no spasticity and 10 = worst possible spasticity.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kayla Chomko, DPT
Phone
954-262-6387
Email
kchomko@nova.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Tabor Gray, PhD
Email
Lauren.Taborgray@nova.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Locatelli, MD, MPH
Organizational Affiliation
Nova Southeastern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Boruch, DO, PhD
Organizational Affiliation
Northeast Regional Medical Center / A.T. Still University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NSU Health Neuroscience Institute
City
Davie
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikole Lesmes-Rincon
Phone
954-262-6387
First Name & Middle Initial & Last Name & Degree
Kayla Chomko, DPT
Email
kchomko@nova.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study will provide pilot data to establish a larger, more robust study. The data will be kept internally.
Citations:
PubMed Identifier
36116464
Citation
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.
Results Reference
background
PubMed Identifier
5026545
Citation
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.
Results Reference
background
PubMed Identifier
4543587
Citation
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.
Results Reference
background
PubMed Identifier
36203296
Citation
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.
Results Reference
background
PubMed Identifier
31333064
Citation
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.
Results Reference
background
PubMed Identifier
33917893
Citation
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.
Results Reference
background
PubMed Identifier
32029539
Citation
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.
Results Reference
background
Links:
URL
https://compasshealthbrands.com/products?pSearch=intensity%20select%20combo%20II
Description
Link to electrical stimulator utilized in this study

Learn more about this trial

Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis

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