Can a simple Skin-Level electric pulse ease muscle stiffness in a rare neurological disease?

NCT ID NCT06012110

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial asks whether a single 30-minute session of transcutaneous electrical stimulation, applied to the back and abdomen, can reduce muscle spasticity and improve walking in people with primary lateral sclerosis (PLS). Participants will attend one clinic visit, receive the stimulation, and have their spasticity, reflexes, gait, and balance assessed before, immediately after, and 24 hours later. The study is small, enrolling only 6 ambulatory adults diagnosed with PLS, and aims to see if this non-invasive approach offers any measurable benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcutaneous electrical stimulation (a device placed on the skin of the back and abdomen)
What this could lead to
If effective, this non-invasive approach could offer a new way to reduce muscle stiffness and improve mobility in people with primary lateral sclerosis.
What could go wrong
This is a very small early-stage trial (6 participants) with a single session, so results may not be generalizable. The effect may be temporary, and individual responses can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

6 people

The number who actually took part.

Started

Aug 2023

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • NSU Health Neuroscience Institute

    Davie, Florida, 33328, United States

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