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Recruiting NCT07010614

Brain Stimulation to the Hippocampus in Schizophrenia

No phase Interventional Schizophrenia Disorders Mental Disorder Psychotic Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intracranial electrodes, TMS, TMS sham.
Who it may be relevant to
Registry conditions: Schizophrenia Disorders, Mental Disorder, Psychotic Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Theta Burst Modulation of Hippocampal-Cortical Rhythms in Schizophrenia

Overview

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.

Interventions

  • Device Intracranial electrodes
    Intracranial electrodes will be used for the delivery of invasive electrical brain stimulation.
  • Device TMS
    TMS will be used for the delivery of noninvasive brain stimulation
  • Device TMS sham
    Sham TMS will be used as a comparator for noninvasive brain stimulation

Primary outcome measures

  • Change in intracranial EEG after one TBS session [Time frame: 45 minutes]
  • Change in scalp EEG after one TBS session [Time frame: 45 minutes]
Secondary outcome measures (2)
  • Change in TMS-provoked EEG power [Time frame: 45 minutes]
  • Change in electrical stimulation provoked iEEG power [Time frame: 45 minutes]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Stanford University — Stanford

Identifiers

NCT: NCT07010614 · 81385

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗