Tests a virtual reality headset for fatigue in multiple sclerosis
Tests a virtual reality headset with gamma sensory stimulation in adults with multiple sclerosis fatigue.
Plain-language title generated from the registry record
Registry title: Virtual Reality - Gamma Sensory Stimulation for Improving Fatigue in People With Multiple Sclerosis
Key facts
- Where
- Barcelona, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07310862, who can take part
Where in Spain
- Hospital del MarBarcelona, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Clarity Health Technologies, Inc
- Trial code
- NCT07310862
- Record updated
- 22 October 2026
- Original description
This is a double-blind, parallel, randomized, sham-controlled pilot study evaluating the safety, feasibility, and efficacy of Gamma Sensory Stimulation (GSS) delivered via a Virtual Reality (VR) headset in individuals with Multiple Sclerosis (MS) who experience moderate to severe fatigue. Participants will be randomized (1:1) to 4 weeks of active GSS or sham stimulation, followed by a 4-week post-treatment follow-up. The primary objective is to determine whether GSS reduces fatigue, measured by the Modified Fatigue Impact Scale (MFIS). Secondary outcomes include additional fatigue scales, cognitive performance, quality-of-life measures, tolerability and safety.Read full original descriptionShow less
Gamma Sensory Stimulation (GSS) for Improving Fatigue in People With Multiple Sclerosis
This is a double-blind, parallel, randomized, sham-controlled pilot study evaluating the safety, feasibility, and efficacy of Gamma Sensory Stimulation (GSS) delivered via a Virtual Reality (VR) headset in individuals with Multiple Sclerosis (MS) who experience moderate to severe fatigue. Participants will be randomized (1:1) to 4 weeks of active GSS or sham stimulation, followed by a 4-week post-treatment follow-up. The primary objective is to determine whether GSS reduces fatigue, measured by the Modified Fatigue Impact Scale (MFIS). Secondary outcomes include additional fatigue scales, cognitive performance, quality-of-life measures, tolerability and safety.
Inclusion: Be between 18 to 65 years of age (inclusive) on the day of signing informed consent; 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); Sufficient hearing and vision; Any type of disease modifying therapy is allowed and should be stable in the last 3 months; Not having received corticosteroids the previous month; 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; Based on the investigator's judgment, the subject should:; Be able to speak, read, and understand the language of the trial staff and the informed consent form; Possess the ability to respond verbally to questions, follow instructions, and complete study assessments; Be able to adhere to the stimulation protocol and visit schedules; 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: The presence of a relapse or use of IV steroids for any reason 3 months prior to screening visit; Clinically relevant concomitant disease: cardiac, gastrointestinal, hepatic, pulmonary, neurological, renal or other major disease; Drug or alcohol abuse; 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; Participation in other experimental studies within the previous 90 days prior to screening visit; Patients having a pacemaker or other metal implants; Any condition or therapy impairing trial participation and assessments; Severe systemic diseases or history of cancer or hereditary familiar cancer; A history of seizure or epilepsy; Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that may interfere with the compliance to the protocol; 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; Pregnant or breastfeeding women.