Causal Role of Rostromedial Prefrontal Cortex for Positive Savoring in Depression
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: Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation.
- Who it may be relevant to
- Registry conditions: Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst, Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst, Left Primary Somatosensory Cortex - Accelerated Intermittent Theta Burst. 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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Overview
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.
Interventions
- Device Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation
For accelerated intermittent theta burst stimulation (aiTBS), stimulation intensity will be set at 80% resting motor threshold (rMT), a level that has been established to be safe and effective. aiTBS will consist of bursts containing 3 pulses at 50 Hz. Bursts will be delivered at 5 Hz for 2 seconds at 80% of rMT, followed by 8 seconds without stimulation. This pattern will continue for 60 cycles (1800 pulses), for a total elapsed time of 10 minutes. Participants will be randomized to receive aiT
Primary outcome measures
- Late Positive Potential during Positive Savoring [Time frame: From baseline EEG to post-stimulation EEG approximately 2 weeks apart]
Secondary outcome measures (1)
- Positive Affect Ratings on the Positive and Negative Affect Schedule (PANAS) [Time frame: From the start to the end of a 3 hour study visit]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Florida State University — Tallahassee
Identifiers
NCT: NCT07467473 · STUDY00006827