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

Not Applicable

• Conditions: Relapse; Heroin Addiction
• Interventions: Device: Repetitive transcranial magnetic stimulation

• Registration Number: NCT04086459
• Lead Sponsor: Tang-Du Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22
• Primary Completion: 2021-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham repetitive transcranial magnetic stimulation	Repetitive transcranial magnetic stimulation	-
Active repetitive transcranial magnetic stimulation	Repetitive transcranial magnetic stimulation	-

Primary Outcome Measures

Name	Time	Method
Change of craving	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	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	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	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	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	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	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	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	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	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	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)

Trial Locations

Locations (1)

Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China