Deep High-Frequency Repetitive Transcranial Magnetic Stimulation for Smoking Cessation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Nicotine consumption(number of cigarets per day and cotinine levels )and craving (questionaires)at end of treatment (3rd week)
研究概览
简要总结
Deep transcranial magnetic stimulation (TMS) is currently being evaluated as a treatment option in major depression. It has been shown to be a safe procedure . Deep transcranial magnetic stimulation coils are designed to maximize the electrical field deep in the brain by the summation of separate fields projected into the skull from several points around its periphery. The device is planned to minimize the accumulation of electrical charge on the surface of the brain. Such accumulation can give rise to an electrostatic field that might reduce the magnitude of the induced electric field both at the surface and inside, thus reducing the depth penetration of the induced electric field . Deep transcranial magnetic stimulation could be more effective than repetitive transcranial magnetic stimulation due to its deeper penetration into brain tissues . The deeper penetration should produce greater action on nerve fibers connecting the prefrontal cortex to the limbic system.
The ability of high-frequency repetitive transcranial magnetic stimulation (rTMS) to alter dopaminergic neurotransmission in subcortical structures could explain recent reports, which suggest that it has the potential to reduce smoking and nicotine craving. Ecihhammer et al demonstrated a reduction in the number of cigarettes smoked and in the desire to smoke after a single rTMS treatment (Eichhammer et al., 2003). In addition, Johan et al in a cross-over, double-blind, placebo-controlled study demonstrated a reduction in cigarette consumption and desire to smoke after a single repetitive transcranial magnetic stimulation treatment (Johann et al., 2003). Recently, the investigators have finished a complete study on nicotine addiction using repetitive transcranial magnetic stimulation for 10 consecutive days. They have found that 10 days of rTMS reduced significantly better from placebo the number of cigarettes smoked, nicotine dependence and craving (Amiaz et al 2007, in preparation). Interestingly, some of the effects were stronger in the sub-group of patients that were presented with smoking-related pictures immediately prior to stimulation onset. Although, these results are interesting and exciting, they have two important caveats. First, only about 50%-60% of the smokers responded to the repetitive transcranial magnetic stimulation treatment. Second, among those responded to the treatment, only 10% had quit totally from smoking. Therefore, the potential therapeutic benefit of this treatment is limited. The investigators' hypothesis is that deep transcranial magnetic stimulation may be more efficient in smoking cessation due to it's deeper penetration and therefore it's capability to stimulate deeper fibers of the dopamine-reward-activating system.
详细描述
Research Plan
I. PARTICIPANTS Male and female cigarette smokers who suffer from COPD. From the general population aged 21-70 who wishes to quit smoking and failed to respond to previous anti-smoking treatment. They will be recruited by advertisements in the newspapers and specific websites. The number of participants in each sub-group (as described in the table below) will be 15-17. The investigators will recruit 90-102 subjects over two years.
II. SCREENING PROCEDURE
Before stimulation procedures onset, participants will undergo a clinical interview. All subject candidates will give written informed consent to take part in the study. Thereafter, they will be tested for their baseline pretreatment level of nicotine addiction in a screening meeting. This includes a report on the level of consumption (number of cigarettes smoked per day and overall duration in years) and a visual analog scale (VAS, see below for details). In addition, a urine sample for cotinine levels (nicotine metabolite) will be obtained in order to objectively measure levels of nicotine. In addition, several self-administered questionnaires will be given to the subjects in order to measure their baseline craving and nicotine dependence:
- Fagerstrom Test of Nicotine Dependence (FTND) (Heatherton et al., 1991). (Appendix no.1a)
- Tobacco Craving Questionnaire (TCQ) (Heishman et al., 2003). (Appendix no.1b)
- Full demographic questionnaire about medical condition and smoking habits. (Appendix no.1c)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, Aged 21-70 years.
- •Subjects who smoke >20 cigarettes per day.
- •Subjects are diagnosed as suffering from COPD
- •Patients who are motivated to quit smoking.
- •Patients who failed to respond to all 3 of the following anti-smoking treatments:
- •po Bupropion (Zyban/Wellbutrin) or Varenicline (Champix)
- •Nicotine patch/ nicotine gum
- •CBT (Cognitive behavioral therapy)
排除标准
- •History of a primary major psychiatric or cognitive disorder according to DSM IV.
- •Current alcohol or other substance abuse or dependence.
- •Alcohol or other substance abuse or dependence during the last 12 months before recruitment.
- •History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder affecting the brain or prior brain surgery.
- •No neurological co-morbidity.
- •No psychiatric co-morbidity.
- •No psychotropic medications.
- •Severe somatic co morbidity.
- •Cardiac pace makers, other electronic implants, intracranial metallic particles.
- •History of seizures or epileptiform activity.
- •Pregnancy and lactation.
- •Patients who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the experiment.
- •Patients unwilling or unable to give written informed consent.
- •Patients with a high risk for severe violence or suicidality as assessed during the screening interview.
- •Participation in a clinical trial within the last 30 days before the beginning of this clinical trial or similar participation in another clinical trial.
结局指标
主要结局
Nicotine consumption(number of cigarets per day and cotinine levels )and craving (questionaires)at end of treatment (3rd week)
时间窗: 3 weeks of treatment (and additional 34 weeks of maintenance & follow-up)
次要结局
- Nicotine consumption(number of cigarets per day and cotinine levels )and craving (questionaires)at end of maintenance & follow-up(37th week)(37 weeks (follow up))
研究者
Pinhas Dannon
Prof. Pinhas Dannon
BeerYaakov Mental Health Center
