Gamma Light and Sound Stimulation in Schizophrenia

Starting soon · Not applicable · Has a placebo group

Conditions studied: Schizophrenia Spectrum Disorders

In brief

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 facts

Study ID

NCT07342465

Run by

Massachusetts Institute of Technology

People needed

20

Starts

2026-04-01

Expected to finish

2027-04-01

Last updated by the study team

2026-01-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 18-65 years of age.
• A diagnosis of schizophrenia or schizoaffective disorder
• No medication is an absolute exclusion. Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following: the patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other CNS (central nervous system) active drugs.
• The subject is willing to sign the informed consent document.
• If the subject is deemed not to have the capacity to sign the informed consent, he/she will need a legally authorized representative to provide surrogate consent.

You may not qualify if…

• Subjects who do not have healthcare
• MRI contraindications such as the presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin or body.
• High myopia < -7 diopters, or untreated cataracts that affect vision.
• Clinical conditions:
• History of seizure or medical diagnosis of epilepsy.
• ECT history > 6 months
• Female subjects who are pregnant or currently breastfeeding.
• Longstanding premorbid history (i.e., longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed.
• Significant neurological or medical disorders that may produce cognitive impairment.
• Profound hearing or visual impairment.
• Eye surgery in the last 3 months or are scheduled to have eye surgery in the next 3 months (during the study)

Where it is running

• Massachusetts Institute of Technology (MIT) — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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