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Neurostimulation
rTMS for Smoking Cessation
Phase 2
Recruiting
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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
4 week continue quit rate
Adverse Event
Cigarette per day
+1 moreSecondary outcome measures
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.
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Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,485 Previous Clinical Trials
2,622,316 Total Patients Enrolled
30 Trials studying Tobacco Use
6,170 Patients Enrolled for Tobacco Use
Medical University of South CarolinaLead Sponsor
940 Previous Clinical Trials
7,396,900 Total Patients Enrolled
9 Trials studying Tobacco Use
42,304 Patients Enrolled for Tobacco Use
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,163 Total Patients Enrolled
8 Trials studying Tobacco Use
8,402 Patients Enrolled for Tobacco Use
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of brain-related autoimmune, endocrine, viral, or vascular disorders.I do not have severe heart, kidney, liver problems, or uncontrolled high blood pressure.I have a neurological disorder that affects my brain or physical abilities.I have never been diagnosed with major mental health disorders like bipolar, schizophrenia, PTSD, dementia, or severe depression.My mental and physical health is stable.I use nicotine products like patches, e-cigarettes, or gum.I have undergone TMS therapy before.I am not pregnant and use reliable birth control methods.I am between 18 and 65 years old.I am motivated to quit smoking.
Research Study Groups:
This trial has the following groups:- Group 1: Sham rTMS
- Group 2: Active rTMS 10 Hz DLPFC
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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