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Multiple SclerosisVR-GSSNCT07310862

Virtual Reality - Gamma Sensory Stimulation for Improving Fatigue in People With Multiple Sclerosis

A study testing Virtual Reality Gamma Sensory Stimulation in people with Multiple Sclerosis, run by Clarity Health Technologies, Inc at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Virtual Reality Gamma Sensory Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteSpain
Study dates
3 Aug 2026to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site, 1 recruiting
  • Hospital del Mar

    Barcelona, Barcelona, 08003

    Delia Paola Ceballos, MD, 932483557, deliapaola.ceballos.saenz@hmar.cat

    Villoslada Pablo, MD, pHD, 93 316 04 38, pvilloslada@researchmar.net

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read the detailed description

Gamma Sensory Stimulation (GSS) is a non-invasive audiovisual neuromodulation method that delivers synchronized 40 Hz stimulation to engage gamma-band neural oscillations. Gamma-frequency activity is implicated in cognitive processing and large-scale network coordination, which may be disrupted in people with Multiple Sclerosis (MS), particularly in those experiencing fatigue. Prior research suggests that gamma-frequency entrainment may modulate neural network activity and support functional outcomes.

This single-center, double-blind, randomized, sham-controlled pilot study investigates whether 4 weeks of GSS delivered through an immersive Virtual Reality (VR) system can reduce fatigue in individuals with MS. Participants with moderate to severe fatigue 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 16 in-lab stimulation sessions delivered over 4 weeks (4 sessions per week). Each session includes 30 minutes of active stimulation within a standardized VR experience.

The primary endpoint is the change in Modified Fatigue Impact Scale (MFIS) total score from baseline to End of Treatment (Week 4). Secondary endpoints include changes from baseline to End of Treatment (Week 4) and follow-up (Week 8) in additional validated fatigue measures (Fatigue Severity Scale, Visual Analogue Scale for Mental Fatigue, PROMIS Fatigue), cognitive performance assessed by the Symbol Digit Modalities Test (SDMT), quality-of-life measures (Neuro-QoL Fatigue), and the rate of change in Daily Fatigue Severity (DFS) across the treatment period. Exploratory outcomes include MFIS subscale scores, variability in daily fatigue ratings, embedded cognitive task performance during stimulation, and treatment acceptability.

Safety and tolerability will be assessed through monitoring of adverse events, session attendance, and retention. Electroencephalography (EEG) will be collected at baseline and at End of Treatment (Week 4) for exploratory characterization of neural responses to gamma-frequency stimulation.

This pilot investigation aims to generate preliminary safety, feasibility, and efficacy data to inform future multisite studies evaluating VR-based GSS as a potential at-home therapeutic approach for MS-related fatigue.

Being tested
Virtual Reality Gamma Sensory Stimulation, Virtual Reality Sham Sensory Stimulation
Keywords
Fatigue, MS fatigue, Cognitive Fatigue, Mental Fatigue, GSS, Gamma Sensory Stimulation, VR-GSS, Virtual Reality, MFIS, Neuromodulation, 40Hz
Medical subject headings
Multiple Sclerosis, Fatigue, Mental Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality Gamma Sensory StimulationDevice

    Also called 40 Hz sensory stimulation, 40 Hz audiovisual stimulation, Gamma flickers, 40Hz flickers

    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.

  • Virtual Reality Sham Sensory StimulationDevice

    Also called sham sensory stimulation, sham VR-GSS

    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.

Study groups in NCT07310862
Study groupRoleWhat they receive
Gamma Sensory StimulationActive 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.
Receives: Device: Virtual Reality Gamma Sensory Stimulation
Sham Sensory StimulationSham 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.
Receives: Device: Virtual Reality Sham Sensory Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to End of Treatment (week 4)

Secondary outcomes (7)
  1. Change in MFIS at Follow up

    MFIS is a 21-item patient-reported fatigue impact scale (range 0-84; higher scores indicate greater fatigue). This outcome assesses change in total MFIS score from baseline to follow-up assessment (Week 8).

    Measured: Baseline to Follow-up (week 8)

  2. Change in Fatigue Severity Scale (FSS)

    The Fatigue Severity Scale (FSS) is a 9-item questionnaire assessing the severity and functional impact of fatigue on daily activities. Each item is scored 1-7; the final score is the mean of all items, with higher scores indicating more severe fatigue. This outcome reflects change in FSS score from baseline to Week 4 and Week 8.

    Measured: Baseline to End of Treatment (week 4) and Follow-up (week 8)

  3. Change in Visual Analogue Scale for Mental Fatigue (VAS-MF)

    VAS-MF is a single-item 0-100 mm visual analogue scale measuring perceived mental fatigue. Higher values indicate greater fatigue. This outcome assesses change in VAS-MF score from baseline to Week 4 and Week 8

    Measured: Baseline to End of Treatment (week 4) and Follow-up (week 8)

  4. Change in PROMIS Fatigue Score

    The PROMIS Fatigue Short Form assesses self-reported fatigue and its interference with daily functioning. Scores are reported as standardized T-scores (mean 50, SD 10); higher scores indicate greater fatigue. This outcome measures change in PROMIS Fatigue from baseline to Week 4 and Week 8.

    Measured: Baseline to End of Treatment (week 4) and Follow-up (week 8)

  5. Change in Neuro-QoL Fatigue

    Neuro-QoL Fatigue evaluates the impact of fatigue on quality of life in neurological conditions. Scores are converted to T-scores (mean 50, SD 10), with higher scores indicating worse fatigue-related QoL. This outcome measures change in Neuro-QoL Fatigue from baseline to Week 4 and Week 8

    Measured: Baseline to End of Treatment (week 4) and Follow-up (week 8)

  6. Change in Symbol Digit Modalities Test (SDMT)

    The SDMT is a widely used measure of information processing speed. The score reflects the number of correct symbol-digit matches completed in 90 seconds, with higher scores indicating better cognitive performance. This outcome assesses change in SDMT score from baseline to Week 4 and Week 8.

    Measured: Baseline to End of Treatment (week 4) and Follow-up (week 8)

  7. Rate of Change in Daily Fatigue Severity (DFS) During the Treatment Period

    Daily Fatigue Severity (DFS) is assessed using a repeated self-reported rating of fatigue severity. Participants respond to the question "How fatigued do you feel today?" using a 7-point Likert scale, where higher scores indicate greater fatigue. This outcome assesses the rate of change in DFS across the treatment period to characterize longitudinal changes in daily fatigue.

    Measured: Baseline through End of treatment (week 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2025
  2. Study start3 Aug 2026
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants with multiple sclerosis and significant fatigue are randomized (1:1) to receive either active Gamma Sensory Stimulation (GSS) or sham stimulation for 4 weeks in a parallel-group design.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07310862
Sponsor's protocol ID
CHT0002
Acronym
VR-GSS
Status last verified
Oct 2026
First submitted
16 Dec 2025
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 40764732
  • 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.

    PubMed 31836315
  • 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.

    PubMed 39112447

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Gamma Sensory Stimulation in people with Multiple Sclerosis, run by Clarity Health Technologies, Inc at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carolina Reis, PhD (+33781261622, carolina@clarity-technologies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Modified Fatigue Impact Scale (MFIS) total score (time frame: Baseline to End of Treatment (week 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07310862, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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VR-GSS Clinical Trial NCT07310862 | AzTrials