RightFit
Not yet recruitingNot applicable

Gamma Light and Sound Stimulation in Schizophrenia

Safety, Feasibility, and Preliminary Efficacy of Non-invasive Gamma Neuromodulation in Individuals With Schizophrenia Spectrum Disorders

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether light and sound flashing and pulsing 40 times per second are safe and may help symptoms, memory, and thinking. It is for adults with schizophrenia or schizoaffective disorder. Participants have a one-day visit to MIT with one hour of stimulation, brain scans, and tests of symptoms and thinking.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 65 years old.
  • You have schizophrenia or schizoaffective disorder, which includes schizophrenia symptoms and mood problems.
  • A study doctor will review your medicines and health history. No medicine automatically rules you out.
  • You are willing to sign a form agreeing to join. If you cannot give consent, a legally approved person must give consent for you.

Who can't join

  • You do not have health care.
  • You have something that makes an MRI scan unsafe, such as a pacemaker, certain implants, or metal in your body.
  • You have severe nearsightedness (below -7 diopters), untreated cataracts that affect sight, or eye surgery within the past 3 months or planned for the next 3 months.
  • You have had seizures or epilepsy. The listing also excludes an ECT history (electrical treatment for mental illness) of “more than 6 months,” but does not clarify the timing.
  • You are pregnant or breastfeeding.
  • You had alcohol or drug abuse for more than 10 years before your illness, continuing through the time your symptoms began.
  • You have a major brain, nerve, or other medical condition that may affect thinking.
  • You have severe hearing or vision loss.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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, he/she will need a legally authorized representative to provide surrogate consent. Exclusion Criteria: 1. Subjects who do not have healthcare 2. 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. 3. High myopia \< -7 diopters, or untreated cataracts that affect vision. 4. Clinical conditions: 1. History of seizure or medical diagnosis of epilepsy. 2. ECT history \> 6 months 3. Female subjects who are pregnant or currently breastfeeding. 4. 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. 5. Significant neurological or medical disorders that may produce cognitive impairment. 6. Profound hearing or visual impairment. 7. Eye surgery in the last 3 months or are scheduled to have eye surgery in the next 3 months (during the study)

Study sites (1)

MA