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VR headset aims to zap MS fatigue in new trial

NCT ID NCT07310862

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This pilot study tests whether a special virtual reality headset that delivers rhythmic light and sound (gamma sensory stimulation) can reduce fatigue in people with multiple sclerosis. Thirty participants with moderate to severe fatigue will receive either the active stimulation or a sham version for 30 minutes, four times a week, for four weeks. The main goal is to see if fatigue scores improve compared to the sham group.

What this could mean

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

Active substance
Gamma Sensory Stimulation (40 Hz audiovisual stimulation) delivered via a virtual reality headset
What this could lead to
If it works, this could offer a non-drug way to ease fatigue in people with multiple sclerosis.
What could go wrong
This is a very small, early pilot study with only 30 people. It may not show a clear benefit, and the effect might not last beyond the treatment period.

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

About 30 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 65 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: 1. Be between 18 to 65 years of age (inclusive) on the day of signing informed consent. 2. Have MS (McDonald criteria 2017) with Modified Fatigue Impact Scale (MFIS) score greater than 33 OR fatigue greater than 4 (out of 7) on the Fatigue Severity Scale (FSS). 3. Sufficient hearing and vision. 4. Any type of disease modifying therapy is allowed and should be stable in the last 3 months. 5. Not having received corticosteroids the previous month. 6. Each subject must sign the informed consent form, in accordance with local requirements, after the scope and nature of the investigation have been explained to the subject, and before Screening assessments. 7. Based on the investigator's judgment, the subject should: 1. Be able to speak, read, and understand the language of the trial staff and the informed consent form; 2. Possess the ability to respond verbally to questions, follow instructions, and complete study assessments; 3. Be able to adhere to the stimulation protocol and visit schedules. 8. Women of child-bearing potential\* must have a negative urine pregnancy test before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include intrauterine device, implant, patch or pill, bilateral tubal occlusion, vasectomized partner and sexual abstinence. Exclusion Criteria: 1. Any condition or therapy impairing trial participation and assessments. 2. The presence of a relapse or use of IV steroids for any reason 3 months prior to screening visit. 3. Severe systemic diseases or history of cancer or hereditary familiar cancer. 4. Clinically relevant concomitant disease: cardiac, gastrointestinal, hepatic, pulmonary, neurological, renal or other major disease. 5. A history of seizure or epilepsy. 6. Pregnant or breastfeeding women. 7. Drug or alcohol abuse. 8. Patients with active systemic bacterial, viral or fungal infections, or known to have uncontrolled AIDS or to be HIV-positive but not receiving anti-retroviral therapy based on medical history or available clinical information at screening. 9. Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that may interfere with the compliance to the protocol. 10. Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the subject at risk by participating in the study. 11. Participation in other experimental studies within the previous 90 days prior to screening visit. 12. Patients having a pacemaker or other metal implants.

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Conditions

The condition(s) this trial relates to.

Fatigue Mental Fatigue multiple sclerosis

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital del Mar

    Barcelona, Barcelona, 08003, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.