Transcranial Magnetic Stimulation and Its Effects on Mayor Depressive Disorder and Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- MINI Neuropsychiatric Interview
研究概览
简要总结
This study evaluates de efficacy of Theta Burst Transcranial Magnetic Stimulation (TMS) applied on the left dorsolateral prefrontal cortex in patients with Major Depressive disorder and tobacco consumption.
详细描述
Major Depressive Disorder (MDD) affects 350 million worldwide causing damage on quality of life and risk behavior such as suicide and smoking. smoking is the second leading cause of death causing about 5 million deaths annually. Theta Burst Stimulation (TBS) is a more tolerable protocol administered at lower intensities and shorter intervals than conventional rTMS protocols.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Triple blind study
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •With dependence on tobacco use, with depressive symptomatology, that they agree to sign the informed consent letter.
排除标准
- •History of head trauma with loss of consciousness, with intracranial metallic objects or metallic plates in the skull, patients with structured suicidal ideation or recent attempts, who suffer from uncontrolled chronic diseases at the time of entering the study (for example: hypertension, diabetes, rheumatic diseases), patients with psychotic symptoms. subjects with alterations in electroencephalogram (epileptiform activity), patients with any type of uncontrolled chronic medical or neurological disease, pregnant women.
结局指标
主要结局
MINI Neuropsychiatric Interview
时间窗: 15 minutes
It is a short structured diagnostic interview that explores the main psychiatric disorders of Axis I of DSM-IV and ICD-10
Fagerström test
时间窗: 5 minutes
it is a short and simple test consisting of 6 questions. The score ranges from 0-10, so that the higher the score, the greater the dependency. Not only does this test measure physical dependence but it also has therapeutic and prognostic value.
Minnesota Nicotine Withdrawal Syndrome Scale (MNWS)
时间窗: 5 minutes
This eight-item scale measures withdrawal symptoms (craving, irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia), The score ranges from 0 to 4, with 4 being the highest score, indicating a severe withdrawal syndrome
Co-oximetry
时间窗: 1 minute
spectrophotometric technique to detect the loss in the oxygenation capacity of hemoglobin that consists of determining the level of carbon monoxide (CO) in the air exhaled by an individual, levels of 10 or more ppm of CO in the exhaled air correspond to smoking subjects. Levels of 6 to 10 ppm in sporadic smokers, and figures below 6 ppm in non-smokers.
Hamilton Anxiety Rating Scale (HARS)
时间窗: 10 minutes
14 Ítem clinical scale for rating anxiety symptoms.
Beck Hopelesness Scale (BHS)
时间窗: 10 minutes
is a 20-item self-report inventory designed to measure 3 major aspects of hopelessness (Feelings about the future, loss of self-motivation and expectations)
Beck suicidal ideation scale (BSIS)
时间窗: 10 minutes
is an evaluation of suicidal thinking: is an evaluation of suicidal thinking that helps identify individuals at risk of comitting self harm
Stop Signal Task
时间窗: 25 minutes
is a unique versión of a classic approach to measuring response inhibition
Test of the Unit of the Institute of Public Health of Madrid (UISPM)
时间窗: 10 minutes
Test consisting of 23 items divided into 6 modules (stimulation, sedation, automatism, social dependency, psychic dependency and gestural dependency) each item is scored from 0 to 4 being 4 the highest score.
Montgomery-Asberg Rating Depression Scale (MADRS)
时间窗: 10 minutes
10 ítem Clinical assessment of the principal depressive symptoms
Beck Depression Invetory (BDI)
时间窗: 10 minutes
it´s a 21 ítem self evaluated symptomatology of depression
Richmond Test
时间窗: 5 minutes
Scale consisting of 4 items to assess the degree of motivation to quit smoking on a scale of 1 to 10. For an individual to have expectations of success in a smoking cessation program, they must present a score of 9 or 10 points
Paradigm of reactivity to signals and heart rate variability
时间窗: 10 minutes
it consists of presenting a series of images that were chosen from the International Series of images for smoking (with neutral counterparts), Version 1.2 (58), the images were presented as follows : 2 blocks of smoking images and 2 blocks with neutral images that are interspersed, each block contains 25 images with a duration of 6 seconds per image, the test has a total duration of 10 minutes; while the participant observes the images, they will place a polar model H10 bluetooh chest strap sensor to measure HRV
Plutchik Risk Suicide Scale
时间窗: 10 minutes
it´s a 26 ítem self-reported scale that assess the intensity of suicidal ideation
Wisconsin Card Sorting Test (WCST)
时间窗: 20 minutes
is a neuropsychological test that assess cognitive flexibility
Glover-Nilsson Test
时间窗: 8 minutes
Test consisting of 11 items to measure the psychosocial and behavioral dependence of individuals; it is scored from 0 to 4, with 4 being the maximum score, items 1,4 and 5 measure psychological dependence, questions 2,3,6,7,8,9 and 10 measure behavioral dependence and question 11 measures social dependence.
Nicotine Craving Questionnaire (CCN)
时间窗: 8 minutes
12-item questionnaire to assess the degree of craving, with five response options ranging from completely disagree 1 to completely agree 5
Hamilton Rating Depression Scale (HDRS)
时间窗: 10 minutes
21 item, Clinical assessment of depressive symptoms
次要结局
- Marlowe and Crowne Social Desirability Scale(10 minutes)
研究者
Dr. Julian Reyes López
Professor
Universidad Autonoma de Queretaro