Schizophrenia Spectrum DisordersSchizophreniaNCT07342465
Gamma Light and Sound Stimulation in Schizophrenia
A study testing GENUS in people with Schizophrenia Spectrum Disorders, run by Massachusetts Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Spectrum Disorders
- What is being tested?
- GENUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
- Clinical conditions:
- History of seizure or medical diagnosis of epilepsy.
- ECT history > 6 months
Show all 11Show fewer
- Female subjects who are pregnant or currently breastfeeding.
- 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.
- Significant neurological or medical disorders that may produce cognitive impairment.
- Profound hearing or visual impairment.
- Eye surgery in the last 3 months or are scheduled to have eye surgery in the next 3 months (during the study)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Remi Philips contact
United States1 site
Massachusetts Institute of Technology (MIT)
Cambridge, Massachusetts, 02139
Mei Xu, PhD, 617-258-7510, xumei@mit.edu
Angelina Singavarapu, BS, 615-439-8581, asingav@mit.edu
About this study
Official title: Safety, Feasibility, and Preliminary Efficacy of Non-invasive Gamma Neuromodulation in Individuals With Schizophrenia Spectrum Disorders
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:
Read more
- Is gamma stimulation safe for patients with schizophrenia spectrum disorders?
- Does gamma stimulation alleviate clinical symptoms and cognitive impairments in schizophrenia patients?
Participants will:
- Have an acute 1-hour stimulation at MIT.
- Come for a one-day visit to MIT for stimulation, neuroimaging, clinical, and cognitive evaluations.
Read the detailed 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 rhythm called gamma oscillation-which normally helps with attention, memory, and perception-does not function properly. These rhythmic signals depend on a healthy balance between brain cells that excite and those that inhibit activity. When this balance is disrupted, it can lead to cognitive and emotional difficulties.
Our study focuses on a new non-invasive approach called Gamma Entrainment Using Sensory Stimulation (GENUS). GENUS uses light and sound flickering at 40 Hz (forty times per second) to gently stimulate the brain and restore its natural rhythmic patterns. Earlier studies have shown that this type of stimulation is safe, well-tolerated, and can improve brain activity and memory in people with Alzheimer's disease.
Because both Alzheimer's disease and schizophrenia involve similar problems with gamma rhythms, GENUS may also help improve brain function and symptoms in people with schizophrenia. This study will test whether 40 Hz light and sound stimulation is safe, feasible, and beneficial for individuals living with schizophrenia. Investigators aim to understand whether this type of sensory stimulation can enhance brain activity and support improvements in thinking and daily functioning
- Conditions
- Schizophrenia Spectrum Disorders
- Being tested
- GENUS, Sham Stimulation
- Keywords
- schizophrenia, sensory stimulation, gamma stimulation, GENUS
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GENUSDevice
Sensory stimulation using light and sound
Sham StimulationDevice
Sham light and sound
| Study group | Role | What they receive |
|---|---|---|
| Gamma Stimulation | Active comparator | 40 Hz light and sound using GENUS device Receives: Device: GENUS |
| Sham Stimulation | Sham comparator | Sham light and sound Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the completion of stimulation
Secondary outcomes (2)
Changes in event related potentials and cognitive performance in 40 Hz ASSR, 2-back and Oddball tasks
Measured: Baseline and immediately after stimulation
Changes in neuroimgaing outcomes
Changes in Glutamate and GABA using MRS and MRI
Measured: Immediately after the completion of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Mclean Hospital
- Responsible party
- Sponsor
- Investigators
- Li-Huei Tsai, PhD, Principal investigator, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342465
- Sponsor's protocol ID
- 2505001650
- Other IDs
- Aging brain initiative
- Acronym
- Schizophrenia
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: All IPD collected throughout the trial, only IPD used in the results publication.
Publications
Iaccarino HF, Singer AC, Martorell AJ, Rudenko A, Gao F, Gillingham TZ, Mathys H, Seo J, Kritskiy O, Abdurrob F, Adaikkan C, Canter RG, Rueda R, Brown EN, Boyden ES, Tsai LH. Gamma frequency entrainment attenuates amyloid load and modifies microglia. Nature. 2016 Dec 7;540(7632):230-235. doi: 10.1038/nature20587.
PubMed 27929004Black T, Jenkins BW, Laprairie RB, Howland JG. Therapeutic potential of gamma entrainment using sensory stimulation for cognitive symptoms associated with schizophrenia. Neurosci Biobehav Rev. 2024 Jun;161:105681. doi: 10.1016/j.neubiorev.2024.105681. Epub 2024 Apr 17.
PubMed 38641090Chan D, Suk HJ, Jackson BL, Milman NP, Stark D, Klerman EB, Kitchener E, Fernandez Avalos VS, de Weck G, Banerjee A, Beach SD, Blanchard J, Stearns C, Boes AD, Uitermarkt B, Gander P, Howard M 3rd, Sternberg EJ, Nieto-Castanon A, Anteraper S, Whitfield-Gabrieli S, Brown EN, Boyden ES, Dickerson BC, Tsai LH. Gamma frequency sensory stimulation in mild probable Alzheimer's dementia patients: Results of feasibility and pilot studies. PLoS One. 2022 Dec 1;17(12):e0278412. doi: 10.1371/journal.pone.0278412. eCollection 2022.
PubMed 36454969
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Feasibility, and Preliminary Efficacy of Non-invasive Gamma Neuromodulation in Individuals With Schizophrenia Spectrum Disorders
- ClinicalTrials.gov ID
- NCT07342465
- Acronym / sponsor ID
- Schizophrenia / 2505001650
- Conditions
- Schizophrenia Spectrum Disorders
- Keywords
- schizophrenia, sensory stimulation, gamma stimulation, GENUS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Collaborators
- Mclean Hospital
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is gamma stimulation safe for patients with schizophrenia spectrum disorders?
- Does gamma stimulation alleviate clinical symptoms and cognitive impairments in schizophrenia patients?
Participants will:
- Have an acute 1-hour stimulation at MIT.
- Come for a one-day visit to MIT for stimulation, neuroimaging, clinical, and cognitive evaluations.
Detailed 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 rhythm called gamma oscillation-which normally helps with attention, memory, and perception-does not function properly. These rhythmic signals depend on a healthy balance between brain cells that excite and those that inhibit activity. When this balance is disrupted, it can lead to cognitive and emotional difficulties.
Our study focuses on a new non-invasive approach called Gamma Entrainment Using Sensory Stimulation (GENUS). GENUS uses light and sound flickering at 40 Hz (forty times per second) to gently stimulate the brain and restore its natural rhythmic patterns. Earlier studies have shown that this type of stimulation is safe, well-tolerated, and can improve brain activity and memory in people with Alzheimer's disease.
Because both Alzheimer's disease and schizophrenia involve similar problems with gamma rhythms, GENUS may also help improve brain function and symptoms in people with schizophrenia. This study will test whether 40 Hz light and sound stimulation is safe, feasible, and beneficial for individuals living with schizophrenia. Investigators aim to understand whether this type of sensory stimulation can enhance brain activity and support improvements in thinking and daily functioning
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamma Stimulation | Active comparator | Device: GENUS40 Hz light and sound using GENUS device |
| Sham Stimulation | Sham comparator | Device: Sham StimulationSham light and sound |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (11 listed)
- 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.
- Clinical conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GENUSSensory stimulation using light and sound | Device | Gamma Stimulation |
| Sham StimulationSham light and sound | Device | Sham Stimulation |
Primary outcome
Safety, feasibility, compliance
Time frame: Immediately after the completion of stimulation
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.
2 secondary outcomes
Changes in event related potentials and cognitive performance in 40 Hz ASSR, 2-back and Oddball tasks
Time frame: Baseline and immediately after stimulation
Changes in neuroimgaing outcomes
Time frame: Immediately after the completion of stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Results publication: PubMed 27929004Iaccarino HF, Singer AC, Martorell AJ, Rudenko A, Gao F, Gillingham TZ, Mathys H, Seo J, Kritskiy O, Abdurrob F, Adaikkan C, Canter RG, Rueda R, Brown EN, Boyden ES, Tsai LH. Gamma frequency entrainment attenuates amyloid load and modifies microglia. Nature. 2016 Dec 7;540(7632):230-235. doi: 10.1038/nature20587.
- Results publication: PubMed 38641090Black T, Jenkins BW, Laprairie RB, Howland JG. Therapeutic potential of gamma entrainment using sensory stimulation for cognitive symptoms associated with schizophrenia. Neurosci Biobehav Rev. 2024 Jun;161:105681. doi: 10.1016/j.neubiorev.2024.105681. Epub 2024 Apr 17.
- Results publication: PubMed 36454969Chan D, Suk HJ, Jackson BL, Milman NP, Stark D, Klerman EB, Kitchener E, Fernandez Avalos VS, de Weck G, Banerjee A, Beach SD, Blanchard J, Stearns C, Boes AD, Uitermarkt B, Gander P, Howard M 3rd, Sternberg EJ, Nieto-Castanon A, Anteraper S, Whitfield-Gabrieli S, Brown EN, Boyden ES, Dickerson BC, Tsai LH. Gamma frequency sensory stimulation in mild probable Alzheimer's dementia patients: Results of feasibility and pilot studies. PLoS One. 2022 Dec 1;17(12):e0278412. doi: 10.1371/journal.pone.0278412. eCollection 2022.
- Individual participant dataSharing planned: Undecided. All IPD collected throughout the trial, only IPD used in the results publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Remi Philips contact
Li-Huei Tsai, PhD principal investigator
Massachusetts Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GENUS in people with Schizophrenia Spectrum Disorders, run by Massachusetts Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mei Xu, PhD ((617) 258-7510, xumei@mit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, feasibility, compliance (time frame: Immediately after the completion of stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07342465, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.