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Neurostimulation

rTMS for Smoking Cessation

N/A
Recruiting
Led By Xingbao Li, MD, MSCR, MS
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks

Summary

This trial will use transcranial magnetic stimulation (TMS) to help people quit smoking cigarettes. TMS is a non-invasive form of brain stimulation that has already been shown to be effective in treating depression and other conditions. This study will use brain MRI to guide TMS therapy.

Who is the study for?
This trial is for adults aged 18-60 who smoke at least 10 cigarettes daily, want to quit smoking, and are in stable health. They must not have had substance abuse treatment recently or use other nicotine products. Pregnant women or those with certain medical conditions like severe heart disease, brain lesions, or metal implants that interfere with MRI scans cannot participate.
What is being tested?
The study tests if rTMS (a non-invasive brain stimulation) can help people stop smoking. Participants will receive either sham (fake) rTMS or active rTMS targeted at specific brain areas using MRI guidance to potentially reduce their craving for cigarettes.
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. It's generally considered safe but might not be suitable for everyone due to individual health factors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
4 week continue quit rate
Adverse Event
Cigarette per day
+1 more
Secondary study objectives
Craving for cigarettes
Prolonged abstinence rate from end of treatment (Week 4) to end of follow-up (Week 20).

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active rTMS 10 Hz DLPFCActive Control1 Intervention
A stimulation frequency of 10 Hz, pulse train duration (on time) of 5 seconds, inter-train interval (off time) of 10 seconds (15 second cycle time), E-field-modeling to determine TMS intensity and coil orientation, total of 60 trains, session time of 15 minutes, and 3000-total pulses per day, will be delivered over the left DLPFC.
Group II: Sham rTMSPlacebo Group1 Intervention
Investigators will use electrode stimulation with 10 Hz over DLPFC, total 3000 pulses. The sham-TMS scalp discomfort was matched to that of active TMS. During real TMS there was no current flowing through the scalp electrodes.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,597 Previous Clinical Trials
3,328,859 Total Patients Enrolled
34 Trials studying Tobacco Use
11,481 Patients Enrolled for Tobacco Use
Medical University of South CarolinaLead Sponsor
977 Previous Clinical Trials
7,400,853 Total Patients Enrolled
9 Trials studying Tobacco Use
42,302 Patients Enrolled for Tobacco Use
National Institutes of Health (NIH)NIH
2,828 Previous Clinical Trials
8,169,627 Total Patients Enrolled
9 Trials studying Tobacco Use
8,640 Patients Enrolled for Tobacco Use

Media Library

Active rTMS 10 Hz DLPFC (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04903028 — N/A
Tobacco Use Research Study Groups: Sham rTMS, Active rTMS 10 Hz DLPFC
Tobacco Use Clinical Trial 2023: Active rTMS 10 Hz DLPFC Highlights & Side Effects. Trial Name: NCT04903028 — N/A
Active rTMS 10 Hz DLPFC (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04903028 — N/A
~23 spots leftby Dec 2026