Testing Bilateral deep accelerated repetitive for tobacco use disorder
Official title: Accelerated dTMS Smoking Cessation
Accelerated Deep Transcranial Magnetic Stimulation for Smoking Cessation
- Phase 2
- 1 group
- Sites in Penetanguishene and Toronto
- Recruiting
Interventions
- Medical device
Bilateral deep accelerated repetitive transcranial magnetic stimulation
Accelerated Repetitive Transcranial Magnetic Stimulation (aTMS) is a type of treatment that will be used to target the bilateral insular cortex and prefrontal cortex using the Health Canada-approved H4 coil. The purpose is to test its feasibility on smoking abstinence. While convention rTMS methods involves one session daily over several weeks, aTMS delivers multiple sessions per day. Using the H4 deep aTMS, this study will implement 20 sessions over five consecutive days (four sessions daily).
Canadian Sites (2)
1 of 2 recruiting
- Recruiting
Waypoint Centre for Mental Health Care
Penetanguishene, Ontario
- Not yet recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Aged 18 years or older;
- +Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7;
- +Must sign and date the informed consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more →;
- +Stated willingness to comply with all study procedures.
- +Able to communicate in English.
- +Tobacco use disorder as assessed by DSM-5;
- +Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4;
Exclusion
- −Serious current or personal history of medical condition/disease (neurological disorders, brain lesions, multiple sclerosis, head trauma, loss of consciousness, hearing loss, etc.) preventing same inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → as per PIPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → (or its delegate) discretion;
- −Contraindication to rTMS;
- −Current or recent history of cerebrovascular disease;
- −Unstable major psychiatric disorder(s) (i.e. Axis I Disorders) that would prevent participation in the study at PI (or its delegate) discretion;
- −Current, personal history or family history of seizures;
- −Concomitant use of medication that lowers seizure threshold, such as clozapine;
- −Concomitant use of more than 2 mg lorazepam (or an equivalent) or any anticonvulsants.
- −Pregnancy, trying to become pregnant or breastfeeding;
- −Reported smoking abstinence in the 3 months preceding screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →;
- −Current use of other smoking cessation aids;
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Bilateral deep accelerated repetitive transcranial magnetic stimulation.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 40 people.
The study is currently expected to finish around January 2028.
The main measurement is taken over: From week 1 day 1, to week 1 day 5 of treatment week.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percentage of Participants Who Discontinue Accelerated dTMS Due to Side EffectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more → — measured over From week 1 day 1, to week 1 day 5 of treatment week.
TMS Experience Questionnaire Acceptability Scores (Units on a Scale) — measured over From week 1 day 1, to week 1 day 5 of treatment week.
Percentage of Participants Completing the 5-day Accelerated dTMS Treatment Course — measured over From week 1 day 1, to week 5 day 5 of treatment week.
Percentage of Treatment Sessions Attended — measured over From week 1 day 1, to week 1 day 5 of treatment week.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07292883 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Bilateral deep accelerated repetitive transcranial magnetic stimulationDevice
Accelerated Repetitive Transcranial Magnetic Stimulation (aTMS) is a type of treatment that will be used to target the bilateral insular cortex and prefrontal cortex using the Health Canada-approved H4 coil. The purpose is to test its feasibility on smoking abstinence. While convention rTMS methods involves one session daily over several weeks, aTMS delivers multiple sessions per day. Using the H4 deep aTMS, this study will implement 20 sessions over five consecutive days (four sessions daily).
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From week 1 day 1, to week 1 day 5 of treatment week..
The study as a whole is currently expected to finish around 2028-01-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 40 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Penetanguishene, Ontario, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of this clinical trial is to examine whether a 5-day course of bilateral accelerated deep transcranial magnetic stimulation (aTMS) is a feasible treatment to help adults (18-65) with Tobacco Use Disorder to quit smoking. This study aims to enroll 30-40 participants and will examine treatment tolerability, treatment acceptability, participant retention, and adherence to scheduled treatment sessions. There are two key objectives and hypotheses: Objective 1: To evaluate whether a 1-week course of bilateral aTMS (4 sessions per day for 5 days) is feasible and tolerable as a smoking cessation treatment. Hypothesis 1: Feasibility will be demonstrated by acceptable tolerability, acceptability, retention, and adherence, with a practical target of 30 out of 40 participants completing the treatment. Objective 2: To explore how aTMS affects smoking outcomes, including: * Point-prevalence abstinence at end of treatment and at Weeks 3, 5, and 9. * Prolonged/continuous abstinence at Weeks 13 and 26. * Craving, cigarettes per day, and dependence severity. Hypothesis 2: Participants will show improvements on these outcomes from post-treatment through follow-up.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.