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

NCT06762535 | Active Not Recruiting

• 1 other identifier: nicotine dependence
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder; Repetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (8)

• Smoking Survey (FTND)

  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

  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)

  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

  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

  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)

  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)

  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

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

  Baseline, 2 week later

Study Arms (3)

Active repetitive transcranial magnetic stimulation

ACTIVE COMPARATOR

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

Sham repetitive transcranial magnetic stimulation

SHAM COMPARATOR

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

No repetitive transcranial magnetic stimulation

NO INTERVENTION

No treatment with a transcranial magnetic stimulator

Interventions

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)

Active repetitive transcranial magnetic stimulation

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.

Sham repetitive transcranial magnetic stimulation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Menghui Yuan, phd

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: January 7, 2025
• Study Start: April 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

CN (1)