Accelerated dTMS Smoking Cessation

April 15, 2026 updated by: Waypoint Centre for Mental Health Care

Accelerated Deep Transcranial Magnetic Stimulation for Smoking Cessation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Penetanguishene, Ontario, Canada
        • Recruiting
        • Waypoint Centre for Mental Health Care
        • Contact:
        • Contact:
        • Principal Investigator:
          • Plabon Ismail, MD
      • Toronto, Ontario, Canada
        • Not yet recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Peter Giacobbe, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 years or older;
  2. Tobacco use disorder as assessed by DSM-5;
  3. Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4;
  4. Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7;
  5. Must sign and date the informed consent form;
  6. Stated willingness to comply with all study procedures.
  7. Able to communicate in English.

Exclusion Criteria:

  1. Reported smoking abstinence in the 3 months preceding screening visit;
  2. Current use of other smoking cessation aids;
  3. Contraindication to rTMS;
  4. Pregnancy, trying to become pregnant or breastfeeding;
  5. Current or recent history of cerebrovascular disease;
  6. Unstable major psychiatric disorder(s) (i.e. Axis I Disorders) that would prevent participation in the study at PI (or its delegate) discretion;
  7. 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 inclusion as per PI (or its delegate) discretion;
  8. Current, personal history or family history of seizures;
  9. Concomitant use of medication that lowers seizure threshold, such as clozapine;
  10. Concomitant use of more than 2 mg lorazepam (or an equivalent) or any anticonvulsants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Accelerated Repetitive Transcranial Magnetic Stimulation
Bilateral Accelerated Repetitive Transcranial Magnetic Stimulation targeting the insula and prefrontal cortex using H4 coil
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).
Other Names:
  • Repetitive TMS
  • Deep TMS
  • Accelerated TMS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Discontinue Accelerated dTMS Due to Side Effects
Time Frame: From week 1 day 1, to week 1 day 5 of treatment week.
Tolerability will be assessed by calculating the percentage of participants who discontinue the 5-day accelerated dTMS treatment course due to side effects.
From week 1 day 1, to week 1 day 5 of treatment week.
TMS Experience Questionnaire Acceptability Scores (Units on a Scale)
Time Frame: From week 1 day 1, to week 1 day 5 of treatment week.
Acceptability will be assessed using scores on the TMS Experience Questionnaire.
From week 1 day 1, to week 1 day 5 of treatment week.
Percentage of Participants Completing the 5-day Accelerated dTMS Treatment Course
Time Frame: From week 1 day 1, to week 5 day 5 of treatment week.
Retention will be measured by the percentage of enrolled participants who complete the full 5-day accelerated dTMS treatment protocol (4 sessions per day for 5 days). The aim is 30 out of 40 participants (75%) completing the course.
From week 1 day 1, to week 5 day 5 of treatment week.
Percentage of Treatment Sessions Attended
Time Frame: From week 1 day 1, to week 1 day 5 of treatment week.
Adherence will be measured by calculating the percentages of planned accelerated dTMS treatment sessions attended (20 sessions total over 5 days). For each participant, adherence will be calculated as number of sessions attended divided by 20, and then calculating a mean percentage.
From week 1 day 1, to week 1 day 5 of treatment week.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The percentage of participants achieving continuous short-term abstinence at follow up
Time Frame: From week 1 day 5 of treatment to week 26.
Measuring the percentage of participants who achieved 7-day point prevalence abstinence at the end of treatment, week 3, week 5, week 9, week, 13, week 26.
From week 1 day 5 of treatment to week 26.
The percentage of participants achieving continuous long-term abstinence at follow up
Time Frame: From week 1 day 1 of treatment to week 26.
Calculating the percentage of participants who achieved prolonged and continuous absence at week 13 (3 months) and week 26 (6 months).
From week 1 day 1 of treatment to week 26.
Change in Tobacco Craving Questionnaire-Short Form (TCQ-SF) Total Score (Units on a Scale)
Time Frame: From baseline to week 26.
This outcome will examine changes in self-reported cravings using the TCQ-SF. TCQ-SF total scores will be compared from baseline to the end of treatment (week 26) and across follow-up visits (week 3, 5, 9, 13, 26).
From baseline to week 26.
Change in Dependence Severity (Units on a Scale)
Time Frame: From baseline to week 26.
This outcome will examine changes in nicotine dependence severity from baseline to the end of treatment (week 26) and during follow-up visits (week 3, 5, 9, 13) using the Fagerstrom Test for Nicotine Dependence (FTND).
From baseline to week 26.
Change in Daily Cigarette Use (Number of Cigarettes per Day)
Time Frame: From baseline to week 26.
This outcome will examine changes in self-reported cigarette consumption using the Timeline Follow Back method from baseline through follow-ups (week 3, 5, 9, 13) to the end of the study (week 26).
From baseline to week 26.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Waypoint Centre for Mental Health Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bernard Le Foll, MD, PhD, MCFP (AM) FCAHS, Waypoint Centre for Mental Health Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5240

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans for use of your study data in other research.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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