Virtual Reality - Gamma Sensory Stimulation for Improving Fatigue in People With Multiple Sclerosis
NCT ID: NCT07310862
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-02-01
2027-03-01
Brief Summary
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Detailed Description
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This single-center, double-blind, randomized, sham-controlled pilot study investigates whether 8 weeks of GSS delivered through an immersive Virtual Reality (VR) system can reduce fatigue in individuals with MS. Participants with significant fatigue and demonstrable neural entrainment to 40 Hz audiovisual stimulation will be randomized in a 1:1 ratio to receive either active GSS or sham stimulation embedded in matched VR content. The intervention consists of 30-minute in-lab sessions, 5 times per week during the first 4 weeks, followed by 3 times per week for an additional 4 weeks.
The primary endpoint is the change in Modified Fatigue Impact Scale (MFIS) total score from baseline to Week 8. Secondary endpoints include changes in other validated measures of fatigue (FSS, VAS-Mental Fatigue, PROMIS Fatigue), cognitive performance assessed by the Symbol Digit Modalities Test (SDMT), and quality-of-life measures (Neuro-QoL Fatigue, PROMIS Fatigue). Exploratory outcomes include MFIS subscales, daily fatigue ratings, and treatment acceptability. Safety and tolerability will be assessed through monitoring of adverse events, session attendance, and retention. EEG will be used at baseline and Week 8 to characterize neural responses to stimulation in the gamma-band.
This pilot investigation aims to generate preliminary efficacy and safety data to inform future multisite trials evaluating VR-GSS as an at-home therapeutic approach for MS-related fatigue.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Gamma Sensory Stimulation
Participants receive 30 minutes of 40 Hz audiovisual stimulation delivered via a VR headset and headphones. Visual brightness and auditory amplitude oscillate at 40 Hz. The content is embedded in engaging VR environments.
Virtual Reality Gamma Sensory Stimulation
Participants receive 30 minutes of Gamma Sensory Stimulation delivered through a VR headset and headphones. Visual brightness and auditory amplitude are modulated synchronously at 40 Hz to induce gamma-band neural entrainment. Sessions occur 5 times per week for 4 weeks, then 3 times per week for 4 additional weeks. Stimulation is embedded within an engaging VR environments.
Sham Sensory Stimulation
Participants receive 30 minutes of sham audiovisual stimulation delivered via a VR headset and headphones. VR content is matched for appearance and engagement to the active condition, but audiovisual signals are modulated in an aperiodic, non-rhythmic pattern rather than periodic fluctuations at 40 Hz, to prevent gamma-band neural entrainment.
Virtual Reality Sham Sensory Stimulation
Participants receive 30 minutes of Sham Sensory Stimulation delivered through a VR headset and headphones. Visual brightness and auditory amplitude are modulated synchronously but at an irregular rate. Sessions occur 5 times per week for 4 weeks, then 3 times per week for 4 additional weeks. Stimulation is embedded within the same engaging VR environments presented in the active intervention.
Interventions
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Virtual Reality Gamma Sensory Stimulation
Participants receive 30 minutes of Gamma Sensory Stimulation delivered through a VR headset and headphones. Visual brightness and auditory amplitude are modulated synchronously at 40 Hz to induce gamma-band neural entrainment. Sessions occur 5 times per week for 4 weeks, then 3 times per week for 4 additional weeks. Stimulation is embedded within an engaging VR environments.
Virtual Reality Sham Sensory Stimulation
Participants receive 30 minutes of Sham Sensory Stimulation delivered through a VR headset and headphones. Visual brightness and auditory amplitude are modulated synchronously but at an irregular rate. Sessions occur 5 times per week for 4 weeks, then 3 times per week for 4 additional weeks. Stimulation is embedded within the same engaging VR environments presented in the active intervention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. Significant neural entrainment to 40Hz audiovisual stimuli.
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
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 including family 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 AIDS or to test positive for HIV antibody at screening.
9. Ongoing known bacterial, viral or fungal infection (with the exception of onychomycosis and dermatomycosis), positive hepatitis B surface antigen or hepatitis C antibody tests at screening.
10. Patients with a known history of syphilis or tuberculosis or test positive for syphilis (positive rapid plasma regain, RPR) or tuberculosis (positive skin test) at screening. Active or latent tuberculosis (TB).
11. Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that may interfere with the compliance to the protocol.
12. 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.
13. Participation in other experimental studies within the previous 90 days prior to screening visit.
14. Patients having a pacemaker or other metal implants.
21 Years
65 Years
ALL
No
Sponsors
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Parc de Salut Mar
OTHER
Clarity Health Technologies, Inc
INDUSTRY
Responsible Party
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Locations
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Hospital del Mar
Barcelona, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Delia Paola Ceballos, MD
Role: primary
Villoslada Pablo, MD, pHD
Role: backup
References
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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.
Adaikkan 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.
Rodrigues-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.
Other Identifiers
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CHT0002
Identifier Type: -
Identifier Source: org_study_id