Virtual Reality - Gamma Sensory Stimulation for Improving Fatigue in People With Multiple Sclerosis
VR-GSS
Gamma Sensory Stimulation (GSS) for Improving Fatigue in People With Multiple Sclerosis
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2025
CompletedFirst Posted
Study publicly available on registry
December 30, 2025
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
February 3, 2026
January 1, 2026
1 year
December 16, 2025
January 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Modified Fatigue Impact Scale (MFIS) total score
The Modified Fatigue Impact Scale (MFIS) is a 21-item patient-reported outcome assessing the impact of fatigue on physical, cognitive, and psychosocial functioning. Scores range from 0 to 84, with higher scores indicating greater fatigue impact. This outcome measures the change in MFIS total score from baseline to Week 4. Negative change values represent improvement in fatigue.
Baseline to End of Treatment (week 4)
Secondary Outcomes (7)
Change in MFIS at Follow up
Baseline to Follow-up (week 8)
Change in Fatigue Severity Scale (FSS)
Baseline to End of Treatment (week 4) and Follow-up (week 8)
Change in Visual Analogue Scale for Mental Fatigue (VAS-MF)
Baseline to End of Treatment (week 4) and Follow-up (week 8)
Change in PROMIS Fatigue Score
Baseline to End of Treatment (week 4) and Follow-up (week 8)
Change in Neuro-QoL Fatigue
Baseline to End of Treatment (week 4) and Follow-up (week 8)
- +2 more secondary outcomes
Other Outcomes (8)
Change in MFIS Subscale Scores (Physical, Cognitive, Psychosocial)
Baseline to End of Treatment (week 4) and Follow-up (week 8)
Cognitive Performance During Stimulation (Embedded Virtual Reality Tasks)
Baseline through End of Treatment (week 4)
Treatment Acceptability Ratings
Week 2, Week 4, and Week 8
- +5 more other outcomes
Study Arms (2)
Gamma Sensory Stimulation
ACTIVE COMPARATORParticipants receive Gamma Sensory Stimulation delivered through a virtual reality (VR) headset and headphones. Stimulation sessions last 30 minutes and are delivered four times per week for four weeks within standardized, engaging VR environments.
Sham Sensory Stimulation
SHAM COMPARATORParticipants receive sham sensory stimulation delivered through a virtual reality (VR) headset and headphones. Sessions last 30 minutes and are delivered four times per week for four weeks within the same VR environments used in the active intervention.
Interventions
Participants receive 30 minutes of Gamma Sensory Stimulation delivered through a virtual reality (VR) headset and headphones. Visual and auditory stimulation parameters are configured to deliver rhythmic sensory stimulation intended to engage gamma-band neural activity. Sessions occur four times per week for four weeks and are embedded within standardized VR environments.
Participants receive 30 minutes of sham sensory stimulation delivered through a virtual reality (VR) headset and headphones. The sham intervention uses identical VR environments, session duration, and procedures as the active intervention, providing an equivalent participant experience without delivering therapeutic stimulation. Sessions occur four times per week for four weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any condition or therapy impairing trial participation and assessments.
- The presence of a relapse or use of IV steroids for any reason 3 months prior to screening visit.
- Severe systemic diseases or history of cancer or hereditary familiar cancer.
- Clinically relevant concomitant disease: cardiac, gastrointestinal, hepatic, pulmonary, neurological, renal or other major disease.
- A history of seizure or epilepsy.
- Pregnant or breastfeeding women.
- 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.
- 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.
- Participation in other experimental studies within the previous 90 days prior to screening visit.
- Patients having a pacemaker or other metal implants.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clarity Health Technologies, Inclead
- Parc de Salut Marcollaborator
Study Sites (1)
Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Related Publications (3)
Reis C, Azizollahi H, Headley G, Navarro S, Hanslmayr S, Clouter A, Zanto TP, Certain R. VR-based gamma sensory stimulation: a pilot feasibility study. Sci Rep. 2025 Aug 5;15(1):28491. doi: 10.1038/s41598-025-13725-6.
PMID: 40764732BACKGROUNDAdaikkan C, Tsai LH. Gamma Entrainment: Impact on Neurocircuits, Glia, and Therapeutic Opportunities. Trends Neurosci. 2020 Jan;43(1):24-41. doi: 10.1016/j.tins.2019.11.001. Epub 2019 Dec 10.
PMID: 31836315BACKGROUNDRodrigues-Amorim D, Bozzelli PL, Kim T, Liu L, Gibson O, Yang CY, Murdock MH, Galiana-Melendez F, Schatz B, Davison A, Islam MR, Shin Park D, Raju RM, Abdurrob F, Nelson AJ, Min Ren J, Yang V, Stokes MP, Tsai LH. Multisensory gamma stimulation mitigates the effects of demyelination induced by cuprizone in male mice. Nat Commun. 2024 Aug 8;15(1):6744. doi: 10.1038/s41467-024-51003-7.
PMID: 39112447BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants, care providers, treating investigators, and outcome assessors are blinded to treatment allocation. Active and sham stimulation are delivered through identical virtual reality content and session procedures, and no perceptual cues are provided that would allow participants or study staff to distinguish between treatment conditions. Device configuration (active or sham mode) is preset by unblinded technical personnel who are not involved in participant interaction, clinical assessments, or data analysis.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2025
First Posted
December 30, 2025
Study Start
March 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
February 3, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
This study collects pseudonymized clinical, behavioral, and EEG data that are subject to GDPR and local data protection regulations. Because the dataset contains sensitive information that cannot be fully de-identified, individual-level data will not be made publicly available. Aggregate results may be shared in publications or upon reasonable request to the sponsor.