Brain Stimulation to the Hippocampus in Schizophrenia

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT07010614
Status
Recruiting
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Conditions

  • Mental Disorder
  • Psychotic Disorder
  • Schizophrenia Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Feb 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Study Team
[email protected]
408-840-3313
Ethan A Solomon, MD, PhD (PRINCIPAL_INVESTIGATOR)

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Stanford University· Stanford, CA

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