Gamma Light and Sound Stimulation in Schizophrenia
ConditionSchizophrenia Spectrum Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMassachusetts Institute of Technology
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
GENUS
DeviceSensory stimulation using light and sound
Sham Stimulation
DeviceSham light and sound
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Gamma StimulationActive comparator 1 intervention
Group B: Sham StimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety, feasibility, compliance
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.
Time frame
Immediately after the completion of stimulationSecondary outcomes
1
Changes in event related potentials and cognitive performance in 40 Hz ASSR, 2-back and Oddball tasks
Time frame
Baseline and immediately after stimulation2
Changes in neuroimgaing outcomes
Changes in Glutamate and GABA using MRS and MRI
Time frame
Immediately after the completion of stimulationOther outcomes
1
Exploratory outcomes - Changes in the Positive and Negative Syndrome Scale
Changes in the clinical symptoms assessment by the Positive and Negative Syndrome Scale
Time frame
Immediately after the completion of stimulation2
Exploratory outcomes - Changes in the Montreal Cognitive Assessment
Changes in cognitive performance assessed by the Montreal Cognitive Assessment
Time frame
Immediately after the completion of stimulation3
Exploratory outcomes - Changes in Inflammatory markers
Changes in Inflammatory markers
Time frame
Immediately after the completion of stimulationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts Institute of Technology
Lead sponsor
Mclean Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: