Causal Role of Rostromedial Prefrontal Cortex for Positive Savoring in Depression (rmPFC-Savoring)

Florida State University

Status: Invitation-only

Conditions: Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst; Left Primary Somatosensory Cortex - Accelerated Intermittent Theta Burst; Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst

Treatments: Device: Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07467473

STUDY00006827

Details and patient eligibility

About

This is a non-invasive brain stimulation and neuroimaging study that will examine how activity in the medial prefrontal cortex influences reward processing, particularly positive savoring, in individuals with depression. The central question is whether modulating medial prefrontal brain regions using transcranial magnetic stimulation (TMS) alters neural and behavioral responses to rewards. Brain activity will be recorded using both electroencephalography (EEG) and functional magnetic resonance imaging (fMRI) while participants perform reward tasks. The primary objectives are to (1) identify patterns of brain activity linked to impaired reward processing in depression using EEG and fMRI, and (2) determine the causal role of specific prefrontal areas in these processes through targeted TMS. The methods include four sessions over four weeks: a clinical assessment, EEG recording during reward tasks after participants learn/practice positive savoring, an fMRI session, and a TMS session combined with EEG while participants practice positive savoring and perform reward tasks during EEG.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between the ages of 18 and 65
• Able to provide informed consent
• Have normal or corrected vision
• Right handed
• Willing to comply with all study procedures and be available for the duration of the study
• Speak and understand English
• Not color blind
• Acceptable suicide risk as determined by less than 5 on the Depression Symptom Index Suicidality Subscale (DSI-SS)
• A diagnosis of major depressive disorder (current episode) on the Structured Clinical Interview for the DSM-5 (SCID-5)
• Between the ages of 18 and 65

Exclusion criteria

• ADHD (currently under treatment)
• Neurological disorders and conditions. Including but not limited to: history of epilepsy, seizures (except childhood febrile seizures), dementia, history of stroke, Parkindon's disease, multiple sclerosis, cerebral aneurysm, brain tumors
• Medical or neurological illness or treatment for a medical disorder that could interfere with study participation. For example, unstable cardiac disease, HIV/AIDS, malignancy, liver or renal impairment
• Prior brain surgery
• Any brain devices/implants, including cochlear implants and aneurysm clips, cardiac pacemaker, or any other implanted electronic device
• History of current traumatic brain injury
• Pregnancy (for females)
• Claustrophobia
• DSM-5 diagnosis of present moderate or severe substance use disorder or alcohol use disorder, and past severe substance use disorder or alcohol use disorder, bipolar disorder, or psychotic disorder
• Based on the use of MRI, additional exclusion criteria are considered. These include participants having ferrous metal in their body, having non-removable jewelry that is ferrous, having tattoos on the face or neck, history of being a metal worker or having an eye injury involving metal
• Anything that in the opinion of the investigator would place the participant at increased risk or preclude the participant's full compliance with or completion of the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups, including a placebo group

Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst

Experimental group

Description:

Accelerated intermittent theta burst will be delivered to left rostromedial prefrontal cortex, which has been previously shown to manipulate reward sensitivity. We are testing if this also impacts positive savoring as measured by the late positive potential during EEG and positive affect. This is an experimental condition that will be compared to an active comparator and a sham comparator.

Treatment:

Device: Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation

Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst

Active Comparator group

Description:

Accelerated intermittent theta burst will be delivered to left dorsolateral prefrontal cortex, which is considered "treatment as usual" for depression.

Treatment:

Device: Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation

Left Primary Somatosensory Cortex - Accelerated Intermittent Theta Burst

Placebo Comparator group

Description:

Accelerated intermittent theta burst will be delivered to left primary somatosensory cortex, which is a placebo intervention condition.

Treatment:

Device: Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation