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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| TBS via transcranial magnetic stimulation | Active Comparator | TMS will be used for the delivery of noninvasive brain stimulation in a theta burst (TBS) pattern. |
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| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracranial electrodes | Device | Intracranial electrodes will be used for the delivery of invasive electrical brain stimulation. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 45 minutes |
| Change in electrical stimulation provoked iEEG power |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Team | Contact | 408-840-3313 | kellerlab@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ethan A Solomon, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
De-identified raw EEG and iEEG data will be shared.
Following publication of the data with no end date.
Anyone who wishes to access the data.
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001523 | Mental Disorders |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| TMS | Device | TMS will be used for the delivery of noninvasive brain stimulation |
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| TMS sham | Device | Sham TMS will be used as a comparator for noninvasive brain stimulation |
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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.
| 45 minutes |