Tobacco Use DisorderNCT06762535
fMRI Study of the Neural Mechanism of rTMS in the Treatment of Nicotine Dependence
A study testing repetitive transcranial magnetic stimulation in people with Tobacco Use Disorder and Repetitive Transcranial Magnetic Stimulation, run by Tang-Du Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Repetitive Transcranial Magnetic Stimulation
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets the DSM-V diagnostic criteria for addiction
- Pure nicotine dependence
- Did not receive medication
- Right-handed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Being tested
- repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham repetitive transcranial magnetic stimulation |
| No repetitive transcranial magnetic stimulation | No intervention | No treatment with a transcranial magnetic stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, 2 week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Apr 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Menghui Yuan, phd, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762535
- Sponsor's protocol ID
- nicotine dependence
- Status last verified
- Jan 2025
- First submitted
- 4 Sep 2023
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06762535
- Acronym / sponsor ID
- nicotine dependence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active repetitive transcranial magnetic stimulation | Active comparator | Device: repetitive transcranial magnetic stimulationIntervention 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. |
| Sham repetitive transcranial magnetic stimulation | Sham comparator | Device: Sham repetitive transcranial magnetic stimulationIntervention 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 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets the DSM-V diagnostic criteria for addiction
- Pure nicotine dependence
- Did not receive medication
- Right-handed
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulationThose 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) | Device | Active repetitive transcranial magnetic stimulation |
| Sham repetitive transcranial magnetic stimulationThose 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. | Device | Sham repetitive transcranial magnetic stimulation |
Primary outcome
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
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.
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.
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
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.
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
Related trials for Tobacco Use Disorder
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menghui Yuan, phd principal investigator
Tang-Du Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation in people with Tobacco Use Disorder and Repetitive Transcranial Magnetic Stimulation, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.