Optimizing Brain Excitability in Depression (TARGET)

Stanford University

Status: Enrolling

Conditions: Major Depressive Disorder

Treatments: Device: Non-optimized (Open-Loop) TMS; Device: Active Single-Pulse TMS; Device: Sham Single-Pulse TMS; Device: TARGET-optimized TMS; Other: EEG Recording; Other: Intracranial EEG (iEEG) Recording

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07242105

1R01MH139650 (U.S. NIH Grant/Contract)

72673-1

Details and patient eligibility

About

The goal of this study is to improve depression treatment by establishing reliable prefrontal excitability markers through Targeting with Automated Real-time Guidance for Enhancing TEPs (TARGET).

Enrollment: 145 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and women, ages 18 to 65
• Diagnosis of major depressive disorder, assessed through a Structured Clinical Interview for DSM-5 (SCID-5)
• In a current depressive episode, assessed through a Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)
• Moderate-to-severe depression as indicated by a score between 11-20 on the Quick Inventory of Depressive Symptoms (QIDS)
• Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
• No current or history of neurological disorders
• No seizure disorder or risk of seizures
• Neurosurgical patients: Men and women ages 18-65 with medication-refractory epilepsy who are admitted for phase II intracranial monitoring to detect a seizure focus will be considered appropriate for this study. Participants must have the intellectual capacity to understand the consent process and agree to the study.

Exclusion criteria

• Those with a contraindication for MRIs (e.g. implanted metal)
• History of head trauma with loss of consciousness
• History of seizures or on medications that reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium)
• Neurological or uncontrolled medical disease
• Any unstable medical condition
• Active substance abuse
• Diagnosis of psychotic or bipolar disorder
• A prior history of Electroconvulsive Therapy (ECT) failure
• History of suicide attempt in the past year
• Currently pregnant or breastfeeding
• Repetitive Transcranial Magnetic Stimulation (rTMS) treatment in the past six months

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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145 participants in 4 patient groups

Active TMS, Sham TMS with iEEG

Experimental group

Description:

Neurosurgical participants receive both active single-pulse Transcranial Magnetic Stimulation (TMS) and sham single-pulse TMS delivered to predefined dlPFC sites while undergoing intracranial EEG recording. The order of active and sham stimulation is randomized.

Treatment:

Other: Intracranial EEG (iEEG) Recording

Device: Sham Single-Pulse TMS

Device: Active Single-Pulse TMS

Sham TMS, Active TMS with iEEG

Experimental group

Description:

Neurosurgical participants receive sham single-pulse TMS followed by active single-pulse TMS at predefined dlPFC sites during intracranial EEG recording. The order of stimulation conditions is randomized.

Treatment:

Other: Intracranial EEG (iEEG) Recording

Device: Sham Single-Pulse TMS

Device: Active Single-Pulse TMS

Optimized TMS, Non-optimized TMS with EEG

Experimental group

Description:

Participants receive both TARGET optimized single-pulse TMS and non-optimized (open-loop) single-pulse TMS to the dlPFC while undergoing concurrent scalp EEG. The sequence of optimized and non-optimized stimulation is randomized.

Treatment:

Other: EEG Recording

Device: TARGET-optimized TMS

Device: Non-optimized (Open-Loop) TMS

Non-optimized TMS, Optimized TMS with EEG

Experimental group

Description:

Participants receive non-optimized (open-loop) single-pulse TMS followed by TARGET optimized single-pulse TMS to the dlPFC with concurrent scalp EEG. The order of stimulation conditions is randomized.

Treatment:

Other: EEG Recording

Device: TARGET-optimized TMS

Device: Non-optimized (Open-Loop) TMS