Clinical trial NCT07010614: Brain Stimulation to the Hippocampus in Schizophrenia
Official title: Theta Burst Modulation of Hippocampal-Cortical Rhythms in Schizophrenia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia Disorders
Mental Disorder
Psychotic Disorder
Keywords: schizophrenia
transcranial magnetic stimulation
TMS
EEG
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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).

Primary outcomes:
measure: Change in intracranial EEG after one TBS session
timeFrame: 45 minutes
measure: Change in scalp EEG after one TBS session
timeFrame: 45 minutes
Secondary outcomes:
measure: Change in TMS-provoked EEG power
timeFrame: 45 minutes
measure: Change in electrical stimulation provoked iEEG power
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Ethan A Solomon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: