NCT07342465

Brief 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. 1.Is gamma stimulation safe for patients with schizophrenia spectrum disorders?
  2. 2.Does gamma stimulation alleviate clinical symptoms and cognitive impairments in schizophrenia patients?
  3. 3.Have an acute 1-hour stimulation at MIT.
  4. 4.Come for a one-day visit to MIT for stimulation, neuroimaging, clinical, and cognitive evaluations.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

November 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

November 21, 2025

Last Update Submit

January 23, 2026

Conditions

Schizophrenia Spectrum Disorders

Keywords

schizophreniasensory stimulationgamma stimulationGENUS

Outcome Measures

Primary Outcomes (1)

  • Safety, feasibility, compliance

    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.

    Immediately after the completion of stimulation

Secondary Outcomes (2)

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

    Baseline and immediately after stimulation

  • Changes in neuroimgaing outcomes

    Immediately after the completion of stimulation

Other Outcomes (3)

  • Exploratory outcomes - Changes in the Positive and Negative Syndrome Scale

    Immediately after the completion of stimulation

  • Exploratory outcomes - Changes in the Montreal Cognitive Assessment

    Immediately after the completion of stimulation

  • Exploratory outcomes - Changes in Inflammatory markers

    Immediately after the completion of stimulation

Study Arms (2)

Gamma Stimulation

ACTIVE COMPARATOR

40 Hz light and sound using GENUS device

Device: GENUS

Sham Stimulation

SHAM COMPARATOR

Sham light and sound

Device: Sham Stimulation

Interventions

GENUSDEVICE

Sensory stimulation using light and sound

Gamma Stimulation
Sham StimulationDEVICE

Sham light and sound

Sham Stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 18-65 years of age.
  • A diagnosis of schizophrenia or schizoaffective disorder
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts Institute of Technology (MIT)

Cambridge, Massachusetts, 02139, United States

Location

Related Publications (3)

  • Iaccarino HF, Singer AC, Martorell AJ, Rudenko A, Gao F, Gillingham TZ, Mathys H, Seo J, Kritskiy O, Abdurrob F, Adaikkan C, Canter RG, Rueda R, Brown EN, Boyden ES, Tsai LH. Gamma frequency entrainment attenuates amyloid load and modifies microglia. Nature. 2016 Dec 7;540(7632):230-235. doi: 10.1038/nature20587.

    PMID: 27929004RESULT

  • Black T, Jenkins BW, Laprairie RB, Howland JG. Therapeutic potential of gamma entrainment using sensory stimulation for cognitive symptoms associated with schizophrenia. Neurosci Biobehav Rev. 2024 Jun;161:105681. doi: 10.1016/j.neubiorev.2024.105681. Epub 2024 Apr 17.

    PMID: 38641090RESULT

  • Chan D, Suk HJ, Jackson BL, Milman NP, Stark D, Klerman EB, Kitchener E, Fernandez Avalos VS, de Weck G, Banerjee A, Beach SD, Blanchard J, Stearns C, Boes AD, Uitermarkt B, Gander P, Howard M 3rd, Sternberg EJ, Nieto-Castanon A, Anteraper S, Whitfield-Gabrieli S, Brown EN, Boyden ES, Dickerson BC, Tsai LH. Gamma frequency sensory stimulation in mild probable Alzheimer's dementia patients: Results of feasibility and pilot studies. PLoS One. 2022 Dec 1;17(12):e0278412. doi: 10.1371/journal.pone.0278412. eCollection 2022.

    PMID: 36454969RESULT

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Li-Huei Tsai, PhD

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Xu, PhD

CONTACT

(617) 258-7510xumei@mit.edu

Remi Philips

CONTACT

remip@mit.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2025

First Posted

January 15, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

US(1)