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

January 5, 2025 updated by: Tang-Du Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Tangdu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active repetitive transcranial magnetic stimulation
Intervention type:Pulse field stimulator of shenzhen yingzhi co., LTD The RTMS treatment target is scheduled for the lateral frontal lobe on the left side. The TMS stimulation frequency is 10Hz, and the stimulation intensity is 100% of the motion threshold 5s, off 10s, for 10 minutes, 2,000 pulses.
Device: repetitive transcranial magnetic stimulation
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 Comparator: Sham repetitive transcranial magnetic stimulation

Intervention type:Pulse field stimulator of shenzhen yingzhi co., LTD The RTMS treatment target is scheduled for the lateral frontal lobe on the left side.

The TMS stimulation frequency is 10Hz, and the stimulation intensity is 100% of the motion threshold 5s, off 10s, for 10 minutes, 2,000 pulses.But there's no real pulse output,Just set the same conditions.
Device: Sham repetitive transcranial magnetic stimulation
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.
No Intervention: No repetitive transcranial magnetic stimulation
No treatment with a transcranial magnetic stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, every day during treatment (up to 10 days),1 week later, 2 week later，3 week later，4week later,5week later,6week later
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.
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)
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.
Baseline, every day during treatment (up to 10 days),End of treatment:1 week later, 2 week later，3 week later，4week later
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
Baseline, every day during treatment (up to 10 days),1 week later, 2 week later，3 week later，4week later,5week later,6week later
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.
Baseline, 6week later
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.
Baseline, 6week later
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.
Baseline, 6week later
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
Baseline, 2 week later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Investigators

  • Principal Investigator: Menghui Yuan, phd, Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

January 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 5, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nicotine dependence

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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