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NOT YET RECRUITING
NCT07310862
NA

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

Sponsor: Clarity Health Technologies, Inc

View on ClinicalTrials.gov

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.

Official title: Gamma Sensory Stimulation (GSS) for Improving Fatigue in People With Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-03-01

Completion Date

2027-04-01

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

DEVICE

Virtual Reality Gamma Sensory Stimulation

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.

DEVICE

Virtual Reality Sham Sensory Stimulation

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.

Locations (1)

Hospital del Mar

Barcelona, Barcelona, Spain