Safety, Feasibility, and Preliminary Efficacy of Non-invasive Gamma Neuromodulation in Individuals With Schizophrenia Spectrum Disorders
Massachusetts Institute of Technology
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.
Description
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 rhyt…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Between 18-65 years of age. 2. A diagnosis of schizophrenia or schizoaffective disorder 3. 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. 4. The subject is willing to sign the informed consent document. 5. If the subject is deemed not to have the capacity to sign the informed consent…
Interventions
- DeviceGENUS
Sensory stimulation using light and sound
- DeviceSham Stimulation
Sham light and sound
Location
- Massachusetts Institute of Technology (MIT)Cambridge, Massachusetts