NCT07010614 · Stanford University
Brain Stimulation to the Hippocampus in Schizophrenia
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Intracranial electrodes
Intracranial electrodes will be used for the delivery of invasive electrical brain stimulation.
DEVICE
TMS
TMS will be used for the delivery of noninvasive brain stimulation
DEVICE
TMS sham
Sham TMS will be used as a comparator for noninvasive brain stimulation
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- 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).
Where
- Stanford, California
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations