Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07342465

Gamma Light and Sound Stimulation in Schizophrenia

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts Institute of Technology (MIT)

Cambridge, Massachusetts, 02139, United States

Location contact

Angelina Singavarapu, BS

CONTACT

[email protected]

615-439-8581

Li-Huei Tsai, PhD

PRINCIPAL_INVESTIGATOR

Mei Xu, PhD

CONTACT

[email protected]

617-258-7510

Mei Xu, PhD

PRINCIPAL_INVESTIGATOR

About this study

Schizophrenia is a serious mental illness that affects about half a percent of people worldwide. It can cause hallucinations, delusions, disorganized thoughts, reduced motivation, and problems with memory and concentration. While current medications can help with hallucinations and delusions, they are often less effective for improving thinking skills and motivation-two areas that strongly affect a person's daily life.

Scientists have found that people with schizophrenia often show changes in how their brain cells communicate and synchronize their activity. In particular, a type of brain rhythm called gamma oscillation-which normally helps with attention, memory, and perception-does not function properly. These rhythmic signals depend on a healthy balance between brain cells that excite and those that inhibit activity. When this balance is disrupted, it can lead to cognitive and emotional difficulties.

Our study focuses on a new non-invasive approach called Gamma Entrainment Using Sensory Stimulation (GENUS). GENUS uses light and sound flickering at 40 Hz (forty times per second) to gently stimulate the brain and restore its natural rhythmic patterns. Earlier studies have shown that this type of stimulation is safe, well-tolerated, and can improve brain activity and memory in people with Alzheimer's disease.

Because both Alzheimer's disease and schizophrenia involve similar problems with gamma rhythms, GENUS may also help improve brain function and symptoms in people with schizophrenia. This study will test whether 40 Hz light and sound stimulation is safe, feasible, and beneficial for individuals living with schizophrenia. Investigators aim to understand whether this type of sensory stimulation can enhance brain activity and support improvements in thinking and daily functioning

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

GENUS

Device

Sensory stimulation using light and sound

Sham stimulation

Device

Sham light and sound

Primary outcomes

  1. Safety, feasibility, compliance

    Time frame: Immediately after the completion of stimulation

    Feasibility of gamma frequency stimulation in subjects with SZ will be assessed by analyzing the neurophysiological data from each subject for a sign of change in gamma frequency waves and determining the percentage of subjects who show this change.

    Tolerability and safety of gamma frequency stimulation will be assessed using questionnaires and measures to rate the subjects' overall experience with the stimulation. These questionnaires will monitor for any adverse effects of the stimulation.

Secondary outcomes

  1. Changes in event related potentials and cognitive performance in 40 Hz ASSR, 2-back and Oddball tasks

    Time frame: Baseline and immediately after stimulation

  2. Changes in neuroimgaing outcomes

    Time frame: Immediately after the completion of stimulation

    Changes in Glutamate and GABA using MRS and MRI

Other outcomes

  1. Exploratory outcomes - Changes in the Positive and Negative Syndrome Scale

    Time frame: Immediately after the completion of stimulation

    Changes in the clinical symptoms assessment by the Positive and Negative Syndrome Scale

  2. Exploratory outcomes - Changes in the Montreal Cognitive Assessment

    Time frame: Immediately after the completion of stimulation

    Changes in cognitive performance assessed by the Montreal Cognitive Assessment

  3. Exploratory outcomes - Changes in Inflammatory markers

    Time frame: Immediately after the completion of stimulation

    Changes in Inflammatory markers

Study contacts

Contact information is provided by the study sponsor or research team.

Mei Xu, PhD

CONTACT

[email protected]

(617) 258-7510

Remi Philips

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Massachusetts Institute of Technology

Other

Collaborators

  • Mclean Hospital

Registry information

Official study title

Safety, Feasibility, and Preliminary Efficacy of Non-invasive Gamma Neuromodulation in Individuals With Schizophrenia Spectrum Disorders

Acronym: Schizophrenia

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.