Causal Role of Rostromedial Prefrontal Cortex for Positive Savoring in Depression
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Late Positive Potential during Positive Savoring
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst
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.
干预措施: Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation (Device)
Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst
Accelerated intermittent theta burst will be delivered to left dorsolateral prefrontal cortex, which is considered "treatment as usual" for depression.
干预措施: Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation (Device)
Left Primary Somatosensory Cortex - Accelerated Intermittent Theta Burst
Accelerated intermittent theta burst will be delivered to left primary somatosensory cortex, which is a placebo intervention condition.
干预措施: Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Late Positive Potential during Positive Savoring
时间窗: From baseline EEG to post-stimulation EEG approximately 2 weeks apart
The late positive potential (LPP) is an established event-related potential that has been shown to be higher when savoring positive feelings elicited by positive images compared to neutral images. Changes in the LPP will be assessed from baseline EEG to post-stimulation EEG and compared between stimulation sites (left rostromedial PFC, left dorsolateral PFC, left primary somatosensory cortex).
次要结局
- Positive Affect Ratings on the Positive and Negative Affect Schedule (PANAS)(From the start to the end of a 3 hour study visit)
研究者
Justin Riddle
Assistant Professor
Florida State University