PET/MRI Study on the Neurological Mechanism of rTMS Treatment for Heroin Addiction

Overview

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.

Full Title of Study: “PET/MRI Study on the Neurological Mechanism of rTMS Treatment for Heroin Addiction by Stimulating Left Dorsolateral Prefrontal Cortex”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: July 1, 2021

Interventions

  • Device: Repetitive transcranial magnetic stimulation
    • Those receiving experimental treatment will receive 20 sessions of rTMS, stimulation protocol included 20 sessions within 30 days (once a day, 5 days/week, 4 weeks, 10 Hz frequency, pulse intensity 100% of the resting motor threshold, 50 pulses per train, inter train pause of 10 s, 40 stimulation trains, 2000 pulses/ session)

Arms, Groups and Cohorts

  • Active Comparator: Active repetitive transcranial magnetic stimulation
  • Sham Comparator: Sham repetitive transcranial magnetic stimulation
  • No Intervention: No repetitive transcranial magnetic stimulation

Clinical Trial Outcome Measures

Primary Measures

  • Change of craving
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Baseline, 1 week later, 1,2,3,4,5,6 months later
    • Depress symptoms scores will be assessed with Beck Depression Inventory
  • Change of anxiety symptoms
    • Time Frame: Baseline, 1 week later, 1,2,3,4,5,6 months later
    • Anxiety symptoms scores will be assessed with Hamilton Anxiety Scale
  • Change of impulsive behaviors
    • Time Frame: Baseline, 1 week later, 1,2,3,4,5,6 months later
    • Impulsive behaviors scores will be assessed with Barratt impulsiveness scale
  • Change of sleep
    • Time Frame: Baseline, 1 week later, 1,2,3,4,5,6 months later
    • Sleep scores will be assessed with Pittsburgh sleep quality index
  • Change of functional connectivity between dorsolateral prefrontal cortex and whole brain
    • Time Frame: 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 gray matter volume of whole brain
    • Time Frame: 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 white matter integrity of whole brain
    • Time Frame: 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)
  • Change of availability of dopamine 2 receptor of whole brain
    • Time Frame: Baseline, 1 month later
    • Accumulation of 11C-raclopride will be analyzed by time-related Positron emission tomography
  • Change of metabolism of glucose in the brain
    • Time Frame: Baseline, 1 month later
    • Accumulation of 18F-FDG will be analyzed by time-related Positron emission tomography

Participating in This Clinical Trial

Inclusion Criteria 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

Exclusion Criteria 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.

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Tang-Du Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Longxiao Wei, phd, Principal Investigator, Tang-Du Hospital
  • Overall Contact(s)
    • Qiang Li, phd, 8615991610831, tdqiangqiang@foxmail.com

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