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

NCT ID: NCT06762535

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-08-01

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.

Conditions

Tobacco Use Disorder; Repetitive Transcranial Magnetic Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

repetitive transcranial magnetic stimulation

Intervention Type: 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)

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.

Group Type: SHAM_COMPARATOR

Sham repetitive transcranial magnetic stimulation

Intervention Type: 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.

No repetitive transcranial magnetic stimulation

No treatment with a transcranial magnetic stimulator

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Menghui Yuan, phd

Role: PRINCIPAL_INVESTIGATOR

Tang-Du Hospital

Locations

Tangdu Hospital

Xi'an, Shaanxi, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

nicotine dependence

Identifier Type: -

Identifier Source: org_study_id