About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
History of seizure or medical diagnosis of epilepsy.
Trial design
Treatments tested in this trial
- GENUS
- Sham Stimulation
Treatment groups
Sponsors and collaborators
Massachusetts Institute of Technology
Lead sponsor
Mclean Hospital
Collaborator