fMRI Study of the Neural Mechanism of rTMS in the Treatment of Nicotine Dependence

Not Applicable

Active, not recruiting

• Conditions: Tobacco Use Disorder; Repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT06762535
• Lead Sponsor: Tang-Du Hospital

Brief Summary

The goal of this clinical trial is to investigate the efficacy of treatment and the efficacy-related neural network mechanisms by stimulating the left dorsolateral prefrontal lobe with rTMS to nicotine dependent.

The main questions it aims to answer are:

* Efficacy of left dorsolateral prefrontal rTMS in the treatment of nicotine dependent subjects.

* The relationship between therapeutic effect and the internal function of the large brain networks of ECN, DMN and SN, and the changes in the interaction between the networks.

Detailed Description

Participants will randomly divided into two groups，Relevant psychological and behavioral data and fMRI data were collected first, and then rTMS was continuously treated for 2 weeks. The above data were collected again after the treatment ended, and then the follow-up was conducted for 1 month. Psychobehavioral data were collected once a week for nicotine addicts.Finally, the collected neuroimage data were analyzed to compare the difference in efficacy between the true and false treatment groups, and to clarify the relationship between the efficacy of nicotine dependent patients after rTMS treatment and the internal functions of the large brain networks of ECN, DMN and SN as well as the interaction characteristics of the networks, so as to provide a scientific basis for the development of effective individualized treatment programs.

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-09-04
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-05
• Last Update Submitted: 2025-01-05
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-04-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Meets the DSM-V diagnostic criteria for addiction
• Pure nicotine dependence
• Did not receive medication
• Right-handed

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Exclusion Criteria

• Patients with organic brain lesions and a history of severe head trauma
• Compliance is poor
• Multiple drug abusers
• Current or past history of mental or neurological disorders
• There was a metallic foreign object in his body
• People with pacemakers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Craving rating (cue)	Baseline, every day during treatment (up to 10 days),End of treatment:1 week later, 2 week later，3 week later，4week later	Craving rating (cue) will be assessed with visual analogue scale,Scores range from 0 to 10, with higher numbers representing higher base desires.
Smoking Survey (FTND)	Baseline, every day during treatment (up to 10 days),1 week later, 2 week later，3 week later，4week later,5week later,6week later	The questions were set according to the time and occasion of smoking every day, and the degree of dependence on tobacco was assessed by scores. Scores range from 0 to 10, The higher the score, the greater the degree of dependence
Foundation desire assessment	Baseline, every day during treatment (up to 10 days),End of treatment:1 week later, 2 week later，3 week later，4week later	Foundation desire assessment will be assessed with visual analogue scale,Scores range from 0 to 10, with higher numbers representing higher base desires.
Smoking per day	Baseline, every day during treatment (up to 10 days),1 week later, 2 week later，3 week later，4week later,5week later,6week later	The number of smoking per day should be filled in according to the actual situation
Desired degree of quitting	Baseline, 6week later	Desired degree of quitting will be assessed with visual analogue scale,Scores range from 0 to 10, with higher numbers representing higher base desires.
Pre-treatment Depression Self-Rating Scale (BDI)	Baseline, 6week later	BDI will be will be assessed with visual analogue scale,Scores range from 0 to 3,The higher the score, the greater the likelihood of depression.
Pre-treatment Anxiety Rating Scale (HAMA)	Baseline, 6week later	HAMA will be assessed with visual analogue scale,Scores range from 0 to 4,The higher the score, the greater the likelihood of anxiety.
Change of functional connectivity between dorsolateral prefrontal cortex and whole brain	Baseline, 2 week later	Functional connectivity based on dorsolateral prefrontal cortex will be measured with magnetic resonance imaging based on blood oxygen level dependence

Trial Locations

Locations (1)

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