Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06762535

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Repetitive Transcranial Magnetic Stimulation Substance-Related Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

Those receiving experimental treatment will receive 10 sessions of rTMS, stimulation protocol included 10 sessions within 14 days (once a day, 5 days/week, 2 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)

Sham repetitive transcranial magnetic stimulation

Device

Those receiving experimental treatment will receive 10 sessions of rTMS, stimulation protocol included 10 sessions within 14 days (once a day, 5 days/week, 2 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).But there's no real pulse output,Just set the same conditions.

Primary outcomes

  1. Smoking Survey (FTND)

    Time frame: 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

  2. Foundation desire assessment

    Time frame: 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.

  3. Craving rating (cue)

    Time frame: 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.

  4. Smoking per day

    Time frame: 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

  5. Desired degree of quitting

    Time frame: 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.

  6. Pre-treatment Depression Self-Rating Scale (BDI)

    Time frame: 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.

  7. Pre-treatment Anxiety Rating Scale (HAMA)

    Time frame: 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.

  8. Change of functional connectivity between dorsolateral prefrontal cortex and whole brain

    Time frame: Baseline, 2 week later

    Functional connectivity based on dorsolateral prefrontal cortex will be measured with magnetic resonance imaging based on blood oxygen level dependence

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.