Accelerated Deep Transcranial Magnetic Stimulation for Smoking Cessation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Percentage of Participants Who Discontinue Accelerated dTMS Due to Side Effects
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Accelerated Repetitive Transcranial Magnetic Stimulation
Bilateral Accelerated Repetitive Transcranial Magnetic Stimulation targeting the insula and prefrontal cortex using H4 coil
干预措施: Bilateral deep accelerated repetitive transcranial magnetic stimulation (Device)
结局指标
主要结局
Percentage of Participants Who Discontinue Accelerated dTMS Due to Side Effects
时间窗: 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.
TMS Experience Questionnaire Acceptability Scores (Units on a Scale)
时间窗: From week 1 day 1, to week 1 day 5 of treatment week.
Acceptability will be assessed using scores on the TMS Experience Questionnaire.
Percentage of Participants Completing the 5-day Accelerated dTMS Treatment Course
时间窗: 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.
Percentage of Treatment Sessions Attended
时间窗: 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.
次要结局
- The percentage of participants achieving continuous short-term abstinence at follow up(From week 1 day 5 of treatment to week 26.)
- The percentage of participants achieving continuous long-term abstinence at follow up(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)(From baseline to week 26.)
- Change in Dependence Severity (Units on a Scale)(From baseline to week 26.)
- Change in Daily Cigarette Use (Number of Cigarettes per Day)(From baseline to week 26.)