Repetitive Transcranial Magnetic Stimulation, Tobacco Use Disorder
Conditions
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.
Interventions
DEVICErepetitive 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)
DEVICESham 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.
Sponsors
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Survey (FTND) | 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 |
| Foundation desire assessment | 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. |
| Craving rating (cue) | 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. |
| Smoking per day | 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 |
| Desired degree of quitting | 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. |
| Pre-treatment Depression Self-Rating Scale (BDI) | 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. |
| Pre-treatment Anxiety Rating Scale (HAMA) | 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. |
| Change of functional connectivity between dorsolateral prefrontal cortex and whole brain | Baseline, 2 week later | Functional connectivity based on dorsolateral prefrontal cortex will be measured with magnetic resonance imaging based on blood oxygen level dependence |
Countries
China
Outcome results
None listed