Primary Lateral SclerosisNCT06012110
Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis
A study testing Transcutaneous electrical stimulation in people with Primary Lateral Sclerosis, run by Nova Southeastern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Primary Lateral Sclerosis
- What is being tested?
- Transcutaneous electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2023to 22 Aug 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary lateral sclerosis by the treating neurologist
- Ambulatory with or without a assistive device or orthotic
Who cannot join
- 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
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- History of seizures or diagnosis of epilepsy
- Open wound at location of electrodes
- Complete loss of sensation at the area of electrode placement
Trial locations and contacts
1 site in 1 country.
United States1 site
NSU Health Neuroscience Institute
Davie, Florida, 33328
About this study
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.
Read the 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.
- Conditions
- Primary Lateral Sclerosis
- Being tested
- Transcutaneous electrical stimulation
- Medical subject headings
- Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
The Modified Ashworth Scale (MAS) is an ordinal scale that ranges from 0 (no increase in muscle tone) to 4 (rigid flexion or extension). Ten muscle groups were assessed bilaterally from 0-4 yielding a possible score of 0-80 where higher values reflect more rigid muscles indicating a worse outcome.
Measured: Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).
Secondary outcomes (5)
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. The DTR scale was utilized on each participant and assessed bilaterally utilizing the Patellar and Achilles tendons with a total possible score of 0 to 16.
Measured: Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).
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.
Measured: Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).
6 Minute Walk Test (6MWT)
The 6MWT assesses overall gait function and endurance. The total distance travelled in 6 minutes is recorded in feet.
Measured: Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).
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. Range is 0-28 points.
Measured: Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).
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.
Measured: Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention) and 24-hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start28 Aug 2023
- Primary completion21 Aug 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Primary Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Locatelli, MD, MPH, Principal investigator, Nova Southeastern UniversityAlan Boruch, DO, PhD, Principal investigator, Northeast Regional Medical Center / A.T. Still University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012110
- Sponsor's protocol ID
- 2023-219-NSU
- Status last verified
- Jul 2026
- First submitted
- 14 Aug 2023
- Last updated
- 25 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This study will provide pilot data to establish a larger, more robust study. The data will be kept internally.
Publications
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.
PubMed 36116464Nashold 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.
PubMed 5026545Cook 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.
PubMed 4543587Lin 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.
PubMed 36203296Hofstoetter 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.
PubMed 31333064Hofstoetter 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.
PubMed 33917893Turner 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.
PubMed 32029539Chomko K, Tabor Gray L, Boruch AV, Locatelli E. Transcutaneous Spinal Cord Stimulation for Spasticity in Primary Lateral Sclerosis: A Case Series. J Neurol Phys Ther. 2026 Oct 1;50(4):e1-e8. doi: 10.1097/NPT.0000000000000558. Epub 2026 May 4.
PubMed 42071279