Brain Stimulation to the Hippocampus in Schizophrenia

NCT ID: NCT07010614

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

TBS via direct electrical stimulation

Intracranial electrodes will be used for the delivery of invasive electrical brain stimulation in a theta burst (TBS) pattern.

Group Type: ACTIVE_COMPARATOR

Intracranial electrodes

Intervention Type: DEVICE

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

TBS via transcranial magnetic stimulation

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

Group Type: ACTIVE_COMPARATOR

TMS

Intervention Type: DEVICE

TMS will be used for the delivery of noninvasive brain stimulation

Sham TBS via direct electrical stimulation

Intracranial electrodes will be used for the delivery of sham invasive brain stimulation (time periods where electrical current is paused).

Group Type: SHAM_COMPARATOR

Intracranial electrodes

Intervention Type: DEVICE

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

Sham TBS via transcranial magnetic stimulation

TMS will be used for the delivery of sham noninvasive brain stimulation (active side of coil turned away from the brain).

Group Type: SHAM_COMPARATOR

TMS sham

Intervention Type: DEVICE

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

Interventions

Intracranial electrodes

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

Intervention Type: DEVICE

TMS

TMS will be used for the delivery of noninvasive brain stimulation

Intervention Type: DEVICE

TMS sham

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

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Ethan Andrew Solomon

Postdoctoral Scholar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ethan A Solomon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Central Contacts

Study Team

Role: CONTACT

kellerlab@stanford.edu

408-840-3313

Facility Contacts

Study Team

Role: primary

kellerlab@stanford.edu

408-840-3313

Other Identifiers

340902

Identifier Type: -

Identifier Source: org_study_id