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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| No repetitive transcranial magnetic stimulation | No Intervention | No treatment with a transcranial magnetic stimulator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Menghui Yuan, phd | Tang-Du Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital | Xi'an | Shaanxi | 710038 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 7, 2024 | Sep 7, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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|
| 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. |
|
| 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 |