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Gamma Light and Sound Stimulation in Schizophrenia

Study acronym: Schizophrenia
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Apr 2027 → Dec 2027
See other at-risk trials from Massachusetts Institute of Technology

Record History

  1. Primary and study completion pushed from Apr 2027 to Dec 2027 Start date: Apr 2026 to Dec 2026 · Eligibility criteria shortened, about 8 words · Publications: details revised at 3 of 3 entries Show 3 more changesShow less
    • Start date: Apr 2026 to Dec 2026
    • Eligibility criteria shortened, about 8 words
    • Publications: details revised at 3 of 3 entries
  2. Start date: Feb 1, 2026 to Apr 2026 Primary and study completion dates: Feb 1, 2027 to Apr 2027v2 Show 1 more changeShow less
    • Primary and study completion dates: Feb 1, 2027 to Apr 2027
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07342465
Lead Sponsor Massachusetts Institute of Technology
Collaborators: Mclean Hospital
Conditions Schizophrenia Spectrum Disorders
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov