Schizophrenia DisordersNCT07010614
Brain Stimulation to the Hippocampus in Schizophrenia
A study testing Intracranial electrodes and TMS in people with Schizophrenia Disorders and Mental Disorder, run by Stanford University at 1 site in United States.
Trial summary
Schizophrenia - marked by delusions, hallucinations, and cognitive deficits - causes the most disability of any mental health condition, but existing treatments have significant side effect burden and are often ineffective. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Disorders, Mental Disorder, Psychotic Disorder
- What is being tested?
- Intracranial electrodes and TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 30 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women, ages 18 to 65 years
- Medically intractable epilepsy requiring phase II monitoring (intracranial EEG arms only)
- DSM-V diagnosis of schizophrenia spectrum Axis I disorders including delusional disorder, brief psychotic disorder, schizophreniform disorder, schizophrenia, schizoaffective disorder (non-invasive TMS-EEG arms only).
- Must have intellectual capacity to ensure adequate comprehension of the study and potential risks involved in order to provide informed consent
- No current or history of major neurological disorders other than epilepsy.
Who cannot join
- DSM5 diagnosis of intellectual disability
- Significant head injury
- Active suicidal ideation or history of suicide attempt within the past 1 year.
- Medical illness affecting brain structure or function, or other uncontrolled or unstable medical condition.
- Pregnancy or postpartum (<6 weeks after delivery or miscarriage)
- Inability to provide informed consent
Show all 9Show fewer
- Active substance abuse other than alcohol or cannabis within the past 1 year
- Psychotic illness with a temporal relation to substance use or head injury
- Those with a contraindication for MRIs or TMS (e.g. implanted metal).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Study Team, 408-840-3313, kellerlab@stanford.edu
Ethan A Solomon, MD, PhD
About this study
Official title: Theta Burst Modulation of Hippocampal-Cortical Rhythms in Schizophrenia
Schizophrenia - marked by delusions, hallucinations, and cognitive deficits - causes the most disability of any mental health condition, but existing treatments have significant side effect burden and are often ineffective. Disordered neural activity in the hippocampus likely contributes to schizophrenia symptoms, but to develop better therapies we need to understand whether hippocampal activity in schizophrenia can be systematically affected by non-invasive brain stimulation techniques like transcranial magnetic stimulation (TMS). This proposal will investigate the use of connectivity-guided theta burst brain stimulation to specifically target hippocampal function in schizophrenia, offering insights into fundamental hippocampal processes, schizophrenia pathophysiology, and potential avenues to use brain stimulation as a therapeutic tool in this devastating illness.
- Conditions
- Schizophrenia Disorders, Mental Disorder, Psychotic Disorder
- Being tested
- Intracranial electrodes, TMS, TMS sham
- Keywords
- schizophrenia, transcranial magnetic stimulation, TMS, EEG
- Medical subject headings
- Schizophrenia, Mental Disorders, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracranial electrodesDevice
Intracranial electrodes will be used for the delivery of invasive electrical brain stimulation.
TMSDevice
TMS will be used for the delivery of noninvasive brain stimulation
TMS shamDevice
Sham TMS will be used as a comparator for noninvasive brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| TBS via direct electrical stimulation | Active comparator | Intracranial electrodes will be used for the delivery of invasive electrical brain stimulation in a theta burst (TBS) pattern. Receives: Device: Intracranial electrodes |
| TBS via transcranial magnetic stimulation | Active comparator | TMS will be used for the delivery of noninvasive brain stimulation in a theta burst (TBS) pattern. Receives: Device: TMS |
| Sham TBS via direct electrical stimulation | Sham comparator | Intracranial electrodes will be used for the delivery of sham invasive brain stimulation (time periods where electrical current is paused). Receives: Device: Intracranial electrodes |
| Sham TBS via transcranial magnetic stimulation | Sham comparator | TMS will be used for the delivery of sham noninvasive brain stimulation (active side of coil turned away from the brain). Receives: Device: TMS sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intracranial EEG after one TBS session
Change in spontaneous oscillatory EEG power from before to after application of one TBS session, for active and sham stimulation, as measured via intracranial recording electrodes (iEEG).
Measured: 45 minutes
Change in scalp EEG after one TBS session
Change in spontaneous oscillatory EEG power from before to after application of one TBS session, for active and sham stimulation, as measured via scalp recording electrodes (scalp electroencephalography).
Measured: 45 minutes
Secondary outcomes (2)
Change in TMS-provoked EEG power
Change in oscillatory EEG power as provoked by repeated single pulses of TMS, compared from before to after a single session of TBS.
Measured: 45 minutes
Change in electrical stimulation provoked iEEG power
Change in oscillatory iEEG power as provoked by repeated single pulses of invasive electrical stimulation, compared from before to after a single session of TBS.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Oct 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ethan Andrew Solomon, Stanford University
- Investigators
- Ethan A Solomon, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010614
- Sponsor's protocol ID
- 81385
- Status last verified
- Feb 2026
- First submitted
- 30 May 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified raw EEG and iEEG data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theta Burst Modulation of Hippocampal-Cortical Rhythms in Schizophrenia
- ClinicalTrials.gov ID
- NCT07010614
- Acronym / sponsor ID
- 81385
- Conditions
- Schizophrenia Disorders, Mental Disorder, Psychotic Disorder
- Keywords
- schizophrenia, transcranial magnetic stimulation, TMS, EEG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 8 Jun 2025 (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 - marked by delusions, hallucinations, and cognitive deficits - causes the most disability of any mental health condition, but existing treatments have significant side effect burden and are often ineffective. Disordered neural activity in the hippocampus likely contributes to schizophrenia symptoms, but to develop better therapies we need to understand whether hippocampal activity in schizophrenia can be systematically affected by non-invasive brain stimulation techniques like transcranial magnetic stimulation (TMS). This proposal will investigate the use of connectivity-guided theta burst brain stimulation to specifically target hippocampal function in schizophrenia, offering insights into fundamental hippocampal processes, schizophrenia pathophysiology, and potential avenues to use brain stimulation as a therapeutic tool in this devastating illness.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TBS via direct electrical stimulation | Active comparator | Device: Intracranial electrodesIntracranial electrodes will be used for the delivery of invasive electrical brain stimulation in a theta burst (TBS) pattern. |
| TBS via transcranial magnetic stimulation | Active comparator | Device: TMSTMS will be used for the delivery of noninvasive brain stimulation in a theta burst (TBS) pattern. |
| Sham TBS via direct electrical stimulation | Sham comparator | Device: Intracranial electrodesIntracranial electrodes will be used for the delivery of sham invasive brain stimulation (time periods where electrical current is paused). |
| Sham TBS via transcranial magnetic stimulation | Sham comparator | Device: TMS shamTMS will be used for the delivery of sham noninvasive brain stimulation (active side of coil turned away from the brain). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women, ages 18 to 65 years
- Medically intractable epilepsy requiring phase II monitoring (intracranial EEG arms only)
- DSM-V diagnosis of schizophrenia spectrum Axis I disorders including delusional disorder, brief psychotic disorder, schizophreniform disorder, schizophrenia, schizoaffective disorder (non-invasive TMS-EEG arms only).
- Must have intellectual capacity to ensure adequate comprehension of the study and potential risks involved in order to provide informed consent
- No current or history of major neurological disorders other than epilepsy.
Key exclusion criteria (9 listed)
- DSM5 diagnosis of intellectual disability
- Significant head injury
- Active suicidal ideation or history of suicide attempt within the past 1 year.
- Medical illness affecting brain structure or function, or other uncontrolled or unstable medical condition.
- Pregnancy or postpartum (<6 weeks after delivery or miscarriage)
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 |
|---|---|---|
| Intracranial electrodesIntracranial electrodes will be used for the delivery of invasive electrical brain stimulation. | Device | Sham TBS via direct electrical stimulation, TBS via direct electrical stimulation |
| TMSTMS will be used for the delivery of noninvasive brain stimulation | Device | TBS via transcranial magnetic stimulation |
| TMS shamSham TMS will be used as a comparator for noninvasive brain stimulation | Device | Sham TBS via transcranial magnetic stimulation |
Primary outcome
Change in intracranial EEG after one TBS session
Time frame: 45 minutes
Change in spontaneous oscillatory EEG power from before to after application of one TBS session, for active and sham stimulation, as measured via intracranial recording electrodes (iEEG).
Change in scalp EEG after one TBS session
Time frame: 45 minutes
Change in spontaneous oscillatory EEG power from before to after application of one TBS session, for active and sham stimulation, as measured via scalp recording electrodes (scalp electroencephalography).
2 secondary outcomes
Change in TMS-provoked EEG power
Time frame: 45 minutes
Change in electrical stimulation provoked iEEG power
Time frame: 45 minutes
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 27 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified raw EEG and iEEG data will be shared.
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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.
Ethan A Solomon, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracranial electrodes and TMS in people with Schizophrenia Disorders and Mental Disorder, run by Stanford University 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 9 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: looking for participants now, as of the sponsor's last update on 27 Feb 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 Study Team (408-840-3313, kellerlab@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intracranial EEG after one TBS session (time frame: 45 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.