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NCT07342465 · ClinicalTrials.gov registry record · NA

Gamma Light and Sound Stimulation in Schizophrenia

A NA study, sponsored by Massachusetts Institute of Technology.

Not yet
Registry status
NA
Development phase
20
Enrollment target

NCT07342465: Clinical Trial NA study, sponsored by Massachusetts Institute of Technology.

NCT07342465 is a NA study that has not yet begun recruiting, run by Massachusetts Institute of Technology. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07342465, a NA study, has not yet begun recruiting, sponsored by Massachusetts Institute of Technology.

NOT YET RECRUITING
Registry status
NA
Development phase
20 participants
Enrollment target

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.

Primary Outcome

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.

Interventions

  • DEVICE GENUS
  • DEVICE Sham Stimulation

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2026-04
Est. Completion 2027-04
Phase NA

What is known before NCT07342465 opens enrollment

NCT07342465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which GENUS is the first listed.

NCT07342465 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07342465 about?

NCT07342465 is a clinical study titled "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 us...

What is the current status of trial NCT07342465?

This trial is currently not yet recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2026-04. Estimated completion is 2027-04.

What interventions are being tested in trial NCT07342465?

The interventions under investigation include: GENUS (DEVICE), Sham Stimulation (DEVICE).

Who is sponsoring clinical trial NCT07342465?

This trial is sponsored by Massachusetts Institute of Technology, which has 24 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07342465's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07342465, the US trial registry maintained by the National Library of Medicine. NCT07342465 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.