Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07010614

Brain Stimulation to the Hippocampus in Schizophrenia

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Schizophrenia Disorders Mental Disorder Mental Disorders Psychotic Disorder Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Ethan A Solomon, MD, PhD

PRINCIPAL_INVESTIGATOR

Study Team

CONTACT

[email protected]

408-840-3313

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intracranial electrodes

Device

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

TMS

Device

TMS will be used for the delivery of noninvasive brain stimulation

TMS sham

Device

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

Primary outcomes

  1. 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).

  2. 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

  1. Change in TMS-provoked EEG power

    Time frame: 45 minutes

    Change in oscillatory EEG power as provoked by repeated single pulses of TMS, compared from before to after a single session of TBS.

  2. Change in electrical stimulation provoked iEEG power

    Time frame: 45 minutes

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Team

CONTACT

[email protected]

408-840-3313

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Theta Burst Modulation of Hippocampal-Cortical Rhythms in Schizophrenia

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.