Could a light bulb fight MS fatigue? small trial begins

NCT ID NCT06261528

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study tests whether a novel light therapy, designed to reset the body's internal clock, is safe and can reduce fatigue in people with progressive multiple sclerosis. Twenty participants will receive the light therapy while researchers monitor side effects and measure changes in tiredness. Fatigue is a common and tough symptom of MS with no approved drug treatments, so a safe, non-drug option could be a big help.

What this could mean

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

Active substance
light therapy device
What this could lead to
If it works, this could point toward a safe, non-drug way to ease fatigue in progressive multiple sclerosis.
What could go wrong
This is a very early phase I trial with only 20 participants, focused on safety. It may not show meaningful fatigue reduction, and results may not apply to all MS patients.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Jul 2026

An estimate. End dates often move.

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 years and older

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: * Age ≥ 18 years old * Diagnosis of PPMS or SPMS according to the 2017, or 2010 Revised McDonald Criteria * In the opinion of the investigator, able to complete study procedures * Epworth Sleepiness Scale (ESS) ≥ 9 * Must be on a stable dose of an FDA-approved disease modifying therapy for at least 3 months prior to screening * Pharmacological and non-pharmacological mood and fatigue treatments must be stable for the previous three months prior to screening and must have intent to keep these stable for the duration of study treatment Exclusion Criteria: * Sleep onset latency under 15 minutes * Pharmacological and non-pharmacological mood and fatigue treatments changes within the previous three months prior to screening * Based on the Investigator's judgement, patients with a history of significant other medical condition that may interfere with the conduct of the study, or interpretation of the study results * History of any clinically significant abnormality in hematology, blood chemistry, or examination not resolved by the baseline visit which according to the investigator can interfere with study participation * Positive drug screen for cocaine, or phencyclidine, or known alcohol abuse within 30 days of the trial * Females who are pregnant, have a provided recent positive pregnancy test, are nursing, or who plan to get pregnant during the course of this clinical trial * Patient taking melatonin analogues without appropriate washout, defined as five half-lives of the medication, or within 14 days of screening, whichever is longer * No new or adjusted prescription medication within 14 days of the baseline * An investigator verified MS relapse within the previous year * Presence of a gadolinium-enhancing demyelinating lesion within the last year * Optic neuritis within the previous 3 months * Sleep schedule changes as required by employment (night shifts) * Travel across two time zones within 3 months of study screening

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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.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • UT Southwestern Medical Center

    Dallas, Texas, 75247, United States

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