Brain Stimulation to the Hippocampus in Schizophrenia

NCT07010614 | Recruiting DMC FDA Device

• 1 other identifier: 81385
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia Disorders; Mental Disorder; Psychotic Disorder

Keywords

schizophrenia; transcranial magnetic stimulation; TMS; EEG

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Change in TMS-provoked EEG power

  45 minutes

• Change in electrical stimulation provoked iEEG power

  45 minutes

Study Arms (4)

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.

Device: Intracranial electrodes

TBS via transcranial magnetic stimulation

ACTIVE COMPARATOR

TMS will be used for the delivery of noninvasive brain stimulation in a theta burst (TBS) pattern.

Device: TMS

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).

Device: Intracranial electrodes

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).

Device: TMS sham

Interventions

Intracranial electrodes DEVICE

Intracranial electrodes will be used for the delivery of invasive electrical brain stimulation.

Sham TBS via direct electrical stimulation; TBS via direct electrical stimulation

TMS DEVICE

TMS will be used for the delivery of noninvasive brain stimulation

TBS via transcranial magnetic stimulation

TMS sham DEVICE

Sham TMS will be used as a comparator for noninvasive brain stimulation

Sham TBS via transcranial magnetic stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Mental Disorders; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Ethan A Solomon, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Team

CONTACT

408-840-3313; kellerlab@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Scholar

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Following publication of the data with no end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

US (1)