PET/MRI Study on the Neurological Mechanism of rTMS Treatment for Heroin Addiction by Stimulating Left Dorsolateral Prefrontal Cortex
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change of craving
研究概览
简要总结
Heroin addiction is a serious problem and the relapse rate of existing treatment methods is extremely high. Recently, international journals such as Science reported that repetitive transcranial magnetic stimulation (rTMS) can reduce the craving of addicts, alleviate depression and anxiety symptoms, and is expected to become an effective treatment. Our preliminary experiment using rTMS to stimulate the left dorsolateral prefrontal cortex of heroin addicts also showed similar effects, however, the mechanism is unclear. Previously, the investigators found that the functional connectivity between left executive control network and default mode network was negatively correlated relapse behavior, while the functional connectivity between salience network and default mode network was positively correlated with relapse behavior. Studies have shown that dopamine dysfunction in addicts and brain metabolism is the biological basis of network connectivity. It suggests that elucidating the relationship between the characteristics of large brain network connectivity and the level of dopamine receptor and relapse behavior in addicts is hopeful to further understand the neurological mechanism of rTMS treatment for addiction. In this project, the investigators intend to observe the changes of brain network connectivity, glucose metabolism and dopamine D2 receptor before and after rTMS treatment in addicts from the perspective of large brain network by combining PET/MRI with psychobehavioral approach. The relationship between rTMS and relapse behavior will be deeply analyzed to provide scientific basis for the development of effective treatment programs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Either the participants, care providers, or outcomes assessors did not know which repetitive transcranial magnetic stimulation is active or sham.
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Heroin-dependent Participants:
- •Clinical diagnosis of heroin addiction
- •Have been receiving treatment in a methadone maintenance treatment program for no less than 6 months
- •have been on a stable dose for at least 1 month before entering the study
- •Right-handed
- •Inclusion Criteria for Healthy Control Participants:
- •Clinical diagnosis of Healthy Control
- •Right-handed
排除标准
- •for all Participants:
- •Current or past psychiatric illness other than heroin and nicotine dependence
- •Neurological signs and/or history of neurological disease
- •History of head trauma
- •History of cardiovascular or endocrine disease
- •Current medical illness or recent medicine use
- •Presence of magnetically active objects in the body
- •Claustrophobia or any other medical condition that would preclude the participant from lying in the PET/MRI scanner for approximately 40 min.
结局指标
主要结局
Change of craving
时间窗: Baseline, 1 week later, 1,2,3,4,5,6 months later
Craving scores will be assessed with visual analogue scale
Change of protracted-abstinence symptoms
时间窗: Baseline, 1 week later, 1,2,3,4,5,6 months later
Protracted-abstinence symptoms scores will be assessed with protracted symptoms questionnaire
Change of depress symptoms
时间窗: Baseline, 1 week later, 1,2,3,4,5,6 months later
Depress symptoms scores will be assessed with Beck Depression Inventory
Change of gray matter volume of whole brain
时间窗: Baseline, 1 week later, 1,3,6 months later
Gray matter volume will be measured with magnetic resonance imaging (high resolution T1-weighted image)
Change of impulsive behaviors
时间窗: Baseline, 1 week later, 1,2,3,4,5,6 months later
Impulsive behaviors scores will be assessed with Barratt impulsiveness scale
Change of functional connectivity between dorsolateral prefrontal cortex and whole brain
时间窗: Baseline, 1 week later, 1,3,6 months later
Functional connectivity based on dorsolateral prefrontal cortex will be measured with magnetic resonance imaging based on blood oxygen level dependence
Change of anxiety symptoms
时间窗: Baseline, 1 week later, 1,2,3,4,5,6 months later
Anxiety symptoms scores will be assessed with Hamilton Anxiety Scale
Change of sleep
时间窗: Baseline, 1 week later, 1,2,3,4,5,6 months later
Sleep scores will be assessed with Pittsburgh sleep quality index
Change of metabolism of glucose in the brain
时间窗: Baseline, 1 month later
Accumulation of 18F-FDG will be analyzed by time-related Positron emission tomography
Change of availability of dopamine 2 receptor of whole brain
时间窗: Baseline, 1 month later
Accumulation of 11C-raclopride will be analyzed by time-related Positron emission tomography
Change of white matter integrity of whole brain
时间窗: Baseline, 1 week later, 1,3,6 months later
Fractional anisotropy, axial diffusivity and radial diffusivity will be measured with magnetic resonance imaging (diffusion tensor imaging)
次要结局
未报告次要终点