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Behavioural Intervention

Transcranial Magnetic Stimulation for Smoking Cessation

Phase 2

Waitlist Available

Research Sponsored by Kent State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed during the baseline session and repeated at the outcome session (following stimulation), occurring on average less than one month apart. primary outcome measure are the ratings collected at the final outcome session.

Awards & highlights

Study Summary

This trial will examine if brain stimulation can help people with tobacco addiction control their craving. It will involve 16 people and test if it improves their ability to control cravings.

Who is the study for?

This trial is for adult smokers aged 18-60 who smoke at least 10 cigarettes daily, have smoked regularly for over a year, and show moderate dependence without plans to quit in the next 3 months. They must pass safety guidelines for rTMS treatment and cannot be using other nicotine products or have certain mental health conditions, substance misuse issues, or be pregnant.Check my eligibility

What is being tested?

The study tests if active repetitive Transcranial Magnetic Stimulation (rTMS) can improve cognitive control over craving compared to a sham procedure. It involves examining brain activation during craving control tasks and assessing the feasibility of targeting rTMS with fMRI-based neuronavigation in tobacco-dependent adults.See study design

What are the potential side effects?

While not explicitly listed here, common side effects of rTMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms of facial muscles, lightheadedness, and rare risk of seizure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed during the baseline session and repeated at the outcome session (following stimulation), occurring on average less than one month apart. primary outcome measure are the ratings collected at the final outcome session.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed during the baseline session and repeated at the outcome session (following stimulation), occurring on average less than one month apart. primary outcome measure are the ratings collected at the final outcome session.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed during the baseline session and repeated at the outcome session (following stimulation), occurring on average less than one month apart. primary outcome measure are the ratings collected at the final outcome session. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Brief Questionnaire of Smoking Urges (QSU - Brief)

Regulation of Craving Task

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active repetitive Transcranial Magnetic Stimulation (rTMS)Experimental Treatment1 Intervention

rTMS will be delivered with a MagPro R-30 magnetic stimulator (MagVenture, Farum, Denmark) Cool-B65 A/P (Active/Placebo). Participants will receive 900 pulses of 20 Hz rTMS per session at 110% of the Motor threshold (MT) (45 20-pulse trains of 1 second duration with an inter-train interval of 20 seconds). MT will be established to determine the intensity of stimulation for each participant, as recommended by safety guidelines. MT will be defined as the amount of energy required to induce a visible twitch in contralateral hand in at least 50% of stimulations. The target stimulation site will be the left DLPFC, specifically: located 6 cm anterior of the MT site identified with assistance from the neuro-navigation system to ensure that the target is located in the middle of the frontal gyrus, in the lateral part of Brodmann Area (BA) 9, near the border of BA 46.

Group II: Sham repetitive Transcranial Magnetic Stimulation (rTMS)Placebo Group1 Intervention

Sham rTMS will appear identical to active treatment, with the exception that the sham side of the coil will be used resulting in no stimulation being applied to the participant, while providing a sensation of stimulation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active repetitive Transcranial Magnetic Stimulation

2022

Completed Phase 2

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kent State UniversityLead Sponsor

41 Previous Clinical Trials

6,587 Total Patients Enrolled

1 Trials studying Smoking

900 Patients Enrolled for Smoking

The Cleveland ClinicOTHER

1,026 Previous Clinical Trials

1,366,070 Total Patients Enrolled

Media Library

Repetitive Transcranial Magnetic Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05651334 — Phase 2

Smoking Research Study Groups: Active repetitive Transcranial Magnetic Stimulation (rTMS), Sham repetitive Transcranial Magnetic Stimulation (rTMS)

Smoking Clinical Trial 2023: Repetitive Transcranial Magnetic Stimulation Highlights & Side Effects. Trial Name: NCT05651334 — Phase 2

Repetitive Transcranial Magnetic Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05651334 — Phase 2

Frequently Asked Questions

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

Is enrollment open for this research endeavor?

"This clinical trial is currently recruiting patients, with the initial posting made on November 8th 2022 and last edited December 6th of that same year."

Answered by AI

Are geriatric individuals included in this research?

"Applicants aged 18 to 60 are eligible for this clinical trial. Meanwhile, 4 studies cater exclusively to those under the age of 18 and 55 trials were developed specifically with elderly patients in mind."

Answered by AI

What measures have been taken to ensure the safety of Active repetitive Transcranial Magnetic Stimulation (rTMS) for patients?

"The team at Power assigned Active Repetitive Transcranial magnetic stimulation (rTMS) a safety rating of 2 due to the lack of efficacy data in Phase 2 studies."

Answered by AI

How many participants are eligible to take part in this experiment?

"Affirmative, the clinical trial is still enrolling participants as evidenced by data available on clinicaltrials.gov. First posted in November 8th 2022 and last updated in December 6th 20202, this study seeks to recruit 16 test subjects at a single medical facility."

Answered by AI

Are there any opportunities for me to participate in this research endeavor?

"This research trial is looking for 16 smokers aged 18 to 60 years old. To be eligible, participants must display moderate nicotine dependence (Fagerstrom score of 4 or more), have no plans to quit in the next 3 months, meet rTMS safety requirements, smoke a minimum of 10 cigarettes daily and generate at least 10 ppm CO levels. Additionally they may not currently use any other nicotine products."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcranial Magnetic Stimulation in Smokers: an Examination of Mediating Neural Pathways.

William Lechner. PhD 2022. "Transcranial Magnetic Stimulation in Smokers: an Examination of Mediating Neural Pathways.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05651334.