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Theta Burst Modulation of Hippocampal-Cortical Rhythms in Schizophrenia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• 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.

Locations
United States
California
Stanford University
RECRUITING
Stanford
Contact Information
Primary
Study Team
kellerlab@stanford.edu
408-840-3313
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 60
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Stanford University
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov

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