Recruiting

TMS

Sponsor:

Stanford University

Code:

NCT07010614

Conditions

Schizophrenia Disorders

Mental Disorder

Psychotic Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Intracranial electrodes

TMS

TMS sham

Study Details

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 ID

NCT07010614

Start date

Oct 1, 2025

Status verified date

Feb, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: TBS via direct electrical stimulation

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

active comparator: TBS via transcranial magnetic stimulation

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

sham comparator: 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).

sham comparator: 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).

Interventions

Intracranial electrodes

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

TMS

TMS will be used for the delivery of noninvasive brain stimulation

TMS sham

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

Primary outcome measure

  • Change in intracranial EEG after one TBS session [ Time Frame: 45 minutes ]
  • Change in scalp EEG after one TBS session [ Time Frame: 45 minutes ]

Central Contacts and Locations

Central contacts

Study Team

408-840-3313kellerlab@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Study Team

408-840-3313kellerlab@stanford.edu

Principal Investigator:

Ethan A Solomon, MD, PhD

More Information

Sponsor

Stanford University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • schizophrenia
  • transcranial magnetic stimulation
  • TMS
  • EEG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-02-27.