Accelerated dTMS Smoking Cessation

Официальное название

Accelerated Deep Transcranial Magnetic Stimulation for Smoking Cessation

Обзор

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.

Вмешательства

• Устройство 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).

Первичные конечные точки

• Percentage of Participants Who Discontinue Accelerated dTMS Due to Side Effects [Срок оценки: From week 1 day 1, to week 1 day 5 of treatment week.]
• TMS Experience Questionnaire Acceptability Scores (Units on a Scale) [Срок оценки: From week 1 day 1, to week 1 day 5 of treatment week.]
• Percentage of Participants Completing the 5-day Accelerated dTMS Treatment Course [Срок оценки: From week 1 day 1, to week 5 day 5 of treatment week.]
• Percentage of Treatment Sessions Attended [Срок оценки: From week 1 day 1, to week 1 day 5 of treatment week.]

Вторичные конечные точки (5)

• The percentage of participants achieving continuous short-term abstinence at follow up [Срок оценки: From week 1 day 5 of treatment to week 26.]
• The percentage of participants achieving continuous long-term abstinence at follow up [Срок оценки: 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) [Срок оценки: From baseline to week 26.]
• Change in Dependence Severity (Units on a Scale) [Срок оценки: From baseline to week 26.]
• Change in Daily Cigarette Use (Number of Cigarettes per Day) [Срок оценки: From baseline to week 26.]

Критерии участия

Критерии включения

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

Критерии исключения

• Reported smoking abstinence in the 3 months preceding screening visit;
• Current use of other smoking cessation aids;
• Contraindication to rTMS;
• Pregnancy, trying to become pregnant or breastfeeding;
• 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;
• 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;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• Waypoint Centre for Mental Health Care — Penetanguishene
• Sunnybrook Health Sciences Centre — Toronto

Идентификаторы

NCT: NCT07292883 · 5240

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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