Clinical trial NCT06762535: fMRI Study of the Neural Mechanism of rTMS in the Treatment of Nicotine Dependence
Official title: fMRI（Functional Magnetic Resonance Imaging,fMRI ) Study of the Neural Mechanism of rTMS(Repetitive Transcranial Magnetic Stimulation,rTMS) Stimulation of the Left Dorsolateral Prefrontal Lobe in the Treatment of Nicotine Dependence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tobacco Use Disorder
Repetitive Transcranial Magnetic Stimulation
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Smoking Survey (FTND)
timeFrame: Baseline, every day during treatment (up to 10 days),1 week later, 2 week later，3 week later，4week later,5week later,6week later
measure: Foundation desire assessment
timeFrame: Baseline, every day during treatment (up to 10 days),End of treatment:1 week later, 2 week later，3 week later，4week later
measure: Craving rating (cue)
timeFrame: Baseline, every day during treatment (up to 10 days),End of treatment:1 week later, 2 week later，3 week later，4week later
measure: Smoking per day
timeFrame: Baseline, every day during treatment (up to 10 days),1 week later, 2 week later，3 week later，4week later,5week later,6week later
measure: Desired degree of quitting
timeFrame: Baseline, 6week later
measure: Pre-treatment Depression Self-Rating Scale (BDI)
timeFrame: Baseline, 6week later
measure: Pre-treatment Anxiety Rating Scale (HAMA)
timeFrame: Baseline, 6week later
measure: Change of functional connectivity between dorsolateral prefrontal cortex and whole brain
timeFrame: Baseline, 2 week later
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
affiliation: Tang-Du Hospital
name: Menghui Yuan, phd
role: PRINCIPAL_INVESTIGATOR
References: