Theta Burst Modulation of Hippocampal-Cortical Rhythms in Schizophrenia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Stanford University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in intracranial EEG after one TBS session
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Change in TMS-provoked EEG power(45 minutes)
- Change in electrical stimulation provoked iEEG power(45 minutes)
Investigators
Ethan Andrew Solomon
Postdoctoral Scholar
Stanford University