Connectivity-guided theta-burst stimulation targeting the hippocampus in schizophrenia
Theta Burst Modulation of Hippocampal-Cortical Rhythms in Schizophrenia
We will try targeted theta-burst TMS guided by brain connectivity to change hippocampus activity in adults with schizophrenia or related psychotic disorders, measuring brain signals with EEG and, for some participants, intracranial electrodes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT07010614 on ClinicalTrials.gov |
What this trial studies
This protocol uses connectivity-guided theta-burst transcranial magnetic stimulation (TBS) to target hippocampal networks implicated in schizophrenia. Non-invasive arms receive TMS with concurrent EEG and sham control to record immediate neural responses, while a separate intracranial arm enrolls patients undergoing phase II intracranial EEG monitoring for direct hippocampal recordings. Researchers will compare brain activity before and after stimulation to determine whether hippocampal function can be systematically modulated. Results are intended to clarify hippocampal contributions to symptoms and to inform future neuromodulation treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–65 with a DSM-5 schizophrenia-spectrum diagnosis for the noninvasive TMS-EEG arms, and adults with medically intractable epilepsy undergoing phase II intracranial EEG monitoring for the intracranial arms.
Not a fit: People with intellectual disability, recent serious suicidal ideation or attempts, significant head injury or other uncontrolled neurological/medical conditions, pregnancy or inability to consent are unlikely to be eligible or to receive benefit from participation.
Why it matters
Potential benefit: If successful, this approach could provide a noninvasive way to alter hippocampal activity and potentially reduce symptoms or cognitive deficits in schizophrenia.
How similar studies have performed: Related connectivity-guided TMS and theta-burst protocols have shown promise in modulating cortical networks and memory in other populations, but hippocampal targeting in schizophrenia remains largely novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Ethan A Solomon, MD, PhD — Stanford University
- Study coordinator: Study Team
- Email: kellerlab@stanford.edu
- Phone: 408-840-3313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.