Health TrialsbyHealthPanel

Brain Stimulation to the Hippocampus in Schizophrenia

ConditionsSchizophrenia DisordersMental DisorderPsychotic Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: TBS via direct electrical stimulationActive comparator 1 intervention
Group B: TBS via transcranial magnetic stimulationActive comparator 1 intervention
Group C: Sham TBS via direct electrical stimulationSham comparator 1 intervention
Group D: Sham TBS via transcranial magnetic stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in intracranial EEG after one TBS session

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).

Time frame
45 minutes
2

Change in scalp EEG after one TBS session

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).

Time frame
45 minutes

Secondary outcomes

1

Change in TMS-provoked EEG power

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

Time frame
45 minutes
2

Change in electrical stimulation provoked iEEG power

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.

Time frame
45 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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