NCT07310862

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Clarity Health Technologies, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2025-12-30
• Last updated: 2026-02-03

Locations

1 site across 1 country: Spain