Neurostimulation

Active rTMS 10 Hz DLPFC for Tobacco Use

Medical University of South Carolina, Charleston, SC

Targeting 2 different conditionsActive rTMS 10 Hz DLPFC +2 morePhase 1 & 2RecruitingResearch 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

Meet the criteria for tobacco use disorder as determined by DSM-5.

Be in stable mental and physical health.

Must not have

Be younger than 18 years old

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up4-week follow-up

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.

Eligible Conditions

Tobacco Use
Smoking/Cigarette Smoking

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You are addicted to tobacco as defined by the DSM-5.

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You are in good physical and mental condition without any major health issues.

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You must be willing to quit smoking based on your responses to a motivation questionnaire.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-week follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-week follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-week follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes of brain connectivity

Mean number of cigarettes smoked per day

Secondary outcome measures

The percentage of participants who have quit by their target quit date

Trial Design

3Treatment 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: Active rTMS 1 Hz mOFCActive Control1 Intervention

A stimulation frequency of 1Hz, E-field-modeling to determine TMS intensity and coil orientation, session time of 15 minutes, and 900-total pulses per day, will be the same for all subjects (both active and sham). TMS will be delivered over the left mOFC.

Group III: Sham rTMSPlacebo Group1 Intervention

Participants will be fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device with adjustable output amplitude and powered by a 9-V battery. We will use electrode stimulation with 10 Hz over DLPFC, total 3000 pulses or 1 Hz over mOFC total 900 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.

0 / 3Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

900 Previous Clinical Trials

5,364,937 Total Patients Enrolled

9 Trials studying Tobacco Use

42,391 Patients Enrolled for Tobacco Use

National Institutes of Health (NIH)NIH

2,611 Previous Clinical Trials

6,663,293 Total Patients Enrolled

7 Trials studying Tobacco Use

8,372 Patients Enrolled for Tobacco Use

Media Library

Active rTMS 10 Hz DLPFC (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04903028 — Phase 1 & 2

Tobacco Use Research Study Groups: Sham rTMS, Active rTMS 10 Hz DLPFC, Active rTMS 1 Hz mOFC

Tobacco Use Clinical Trial 2023: Active rTMS 10 Hz DLPFC Highlights & Side Effects. Trial Name: NCT04903028 — Phase 1 & 2

Active rTMS 10 Hz DLPFC (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04903028 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project allow for elderly participation?

"This study is looking for test subjects who fall in the age range of 18 to 60 years old."

Answered by AI

Are there any restrictions for people who want to join this clinical trial?

"45 participants will be accepted into this trial that focuses on helping smokers quit cigarettes. To qualify, patients must have smoked within the last month and be aged 18-60."

Answered by AI

Are people currently being recruited for this trial?

"The trial is recruiting patients, as indicated by the clinicaltrials.gov website. This study was first made available on May 15th, 2021 and has been updated as recently as April 20th, 2022."

Answered by AI

How many people are joining this clinical trial?

"That is correct, the clinical trial detailed on clinicaltrials.gov is currently open and recruiting patients. This specific study was posted on May 15th, 2021 and updated April 20th, 2022. 45 individuals are needed from 1 location."

Answered by AI

Recent research and studies

Biological PsychiatryJournal

Smoking Cessation Induced by Deep Repetitive Transcranial Magnetic Stimulation of the Prefrontal and Insular Cortices: A Prospective, Randomized Controlled Trial

Dinur-Klein, Limor, Pinhas Dannon, Aviad Hadar, Oded Rosenberg, Yiftach Roth, Moshe Kotler, and Abraham Zangen. 2014. “Smoking Cessation Induced by Deep Repetitive Transcranial Magnetic Stimulation of the Prefrontal and Insular Cortices: A Prospective, Randomized Controlled Trial”. Biological Psychiatry. Elsevier BV. doi:10.1016/j.biopsych.2014.05.020.

The American Journal on AddictionsJournal

Transcranial Magnetic Stimulation of the Dorsal Lateral Prefrontal Cortex Inhibits Medial Orbitofrontal Activity in Smokers

Li, Xingbao, Gregory L. Sahlem, Bashar W. Badran, Lisa M. McTeague, Colleen A. Hanlon, Karen. J. Hartwell, Scott Henderson, and Mark S. George. 2017. “Transcranial Magnetic Stimulation of the Dorsal Lateral Prefrontal Cortex Inhibits Medial Orbitofrontal Activity in Smokers”. The American Journal on Addictions. Wiley. doi:10.1111/ajad.12621.

Biological PsychiatryJournal

Repetitive Transcranial Magnetic Stimulation of the Dorsolateral Prefrontal Cortex Reduces Nicotine Cue Craving

Li, Xingbao, Karen J. Hartwell, Max Owens, Todd LeMatty, Jeffrey J. Borckardt, Colleen A. Hanlon, Kathleen T. Brady, and Mark S. George. 2013. “Repetitive Transcranial Magnetic Stimulation of the Dorsolateral Prefrontal Cortex Reduces Nicotine Cue Craving”. Biological Psychiatry. Elsevier BV. doi:10.1016/j.biopsych.2013.01.003.

Drug and Alcohol DependenceJournal