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Gamma Light and Sound Stimulation in Schizophrenia

NCT07342465 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-26

No results posted yet for this study

Summary

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.

Conditions

  • Schizophrenia Spectrum Disorders

Interventions

DEVICE

GENUS

Sensory stimulation using light and sound

DEVICE

Sham Stimulation

Sham light and sound

Sponsors & Collaborators

Principal Investigators

  • Li-Huei Tsai, PhD · Massachusetts Institute of Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07342465 on ClinicalTrials.gov