Gamma Light and Sound Stimulation in Schizophrenia

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Massachusetts Institute of Technology
Study ID
NCT07342465
Status
Not Yet Recruiting

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Conditions

  • Schizophrenia Spectrum Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • GENUS — DEVICE
    Sensory stimulation using light and sound
  • Sham Stimulation — DEVICE
    Sham light and sound

Study Details

Schizophrenia (SZ) is a severe neuropsychiatric disorder impacting over 20 million people globally, causing significant personal and societal burdens, particularly due to cognitive deficits and negative symptoms inadequately treated by current therapies. To address this gap, investigators propose using Gamma Entrainment Using Sensory Stimulation (GENUS), a novel, home-based treatment involving synchronized 40 Hz light-and-sound stimulation aimed at improving neural synchrony, cognition, and SZ symptoms. This innovative approach leverages advanced neurostimulation, biological, and neuroimaging methods to directly target gamma dysfunction, fulfilling an urgent need for effective and accessible at-home therapies. The goal of this clinical trial is to learn about the safety and feasibility of gamma stimulation using light and sound. It will also learn if gamma stimulation using light and sound works to treat clinical symptoms and cognitive impairments in schizophrenia. The main questions it aims to answer are: 1. Is gamma stimulation safe for patients with schizophrenia spectrum disorders? 2. Does gamma stimulation alleviate clinical symptoms and cognitive impairments in schizophrenia patients? Participants will: 1. Have an acute 1-hour stimulation at MIT. 2. Come for a one-day visit to MIT for stimulation, neuroimaging, clinical, and cognitive evaluations.

Key Dates

Start date
Apr 30, 2026
Status verified
Jan 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Gamma Stimulation
    40 Hz light and sound using GENUS device
  • Sham Comparator: Sham Stimulation
    Sham light and sound

Primary Outcome Measure

Safety, feasibility, compliance [ Time Frame: Immediately after the completion of stimulation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Institute of Technology (MIT)CambridgeMassachusetts02139
Mei Xu, PhD
[email protected]
617-258-7510
Angelina Singavarapu, BS
[email protected]
615-439-8581
Li-Huei Tsai, PhD (PRINCIPAL_INVESTIGATOR)
Mei Xu, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts Institute of Technology (MIT)· Cambridge, MA

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