Transcranial Magnetic Stimulation Theta Burst (TMS), Depression and Smoking.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transcranial Magnetic Stimulation and Its Effects on Mayor Depressive Disorder and Smoking Cessation

Conditions
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Major Depressive Disorder, Smoking Reduction

Intervention / Treatment
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* Device: Theta Burst Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With dependence on tobacco use, with depressive symptomatology, that they agree to sign the informed consent letter. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 session<br>Participants will receive 1 session from monday to friday,during 4 weeks, with 600 total pulses per session | Device: Theta Burst Transcranial Magnetic Stimulation<br>* Magventure MagPro R30 stimulation Device, MCF-B70 stimulation Coill<br>|
| Experimental: 3 sessions<br>Participants will receive 3 sessions from monday to friday,during 4 weeks, with 1800 total pulses per session with a 10 minutes rest interval | Device: Theta Burst Transcranial Magnetic Stimulation<br>* Magventure MagPro R30 stimulation Device, MCF-B70 stimulation Coill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MINI Neuropsychiatric Interview | It is a short structured diagnostic interview that explores the main psychiatric disorders of Axis I of DSM-IV and ICD-10 | 15 minutes | 
| Fagerström test | 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. | 5 minutes | 
| Richmond Test | 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 | 5 minutes | 
| Glover-Nilsson Test | 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. | 8 minutes | 
| Test of the Unit of the Institute of Public Health of Madrid (UISPM) | 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. | 10 minutes | 
| Minnesota Nicotine Withdrawal Syndrome Scale (MNWS) | 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 | 5 minutes | 
| Nicotine Craving Questionnaire (CCN) | 12-item questionnaire to assess the degree of craving, with five response options ranging from completely disagree 1 to completely agree 5 | 8 minutes | 
| Paradigm of reactivity to signals and heart rate variability | 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 | 10 minutes | 
| Co-oximetry | 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. | 1 minute | 
| Hamilton Rating Depression Scale (HDRS) | 21 item, Clinical assessment of depressive symptoms | 10 minutes | 
| Montgomery-Asberg Rating Depression Scale (MADRS) | 10 ítem Clinical assessment of the principal depressive symptoms | 10 minutes | 
| Hamilton Anxiety Rating Scale (HARS) | 14 Ítem clinical scale for rating anxiety symptoms. | 10 minutes | 
| Beck Depression Invetory (BDI) | it´s a 21 ítem self evaluated symptomatology of depression | 10 minutes | 
| Beck Hopelesness Scale (BHS) | 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) | 10 minutes | 
| Plutchik Risk Suicide Scale | it´s a 26 ítem self-reported scale that assess the intensity of suicidal ideation | 10 minutes | 
| Beck suicidal ideation scale (BSIS) | is an evaluation of suicidal thinking: is an evaluation of suicidal thinking that helps identify individuals at risk of comitting self harm | 10 minutes | 
| Wisconsin Card Sorting Test (WCST) | is a neuropsychological test that assess cognitive flexibility | 20 minutes | 
| Stop Signal Task | is a unique versión of a classic approach to measuring response inhibition | 25 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marlowe and Crowne Social Desirability Scale | self-applied scale consisting of 33 items for the evaluation of the need for social approval, for example, generating a good impression through socially appropriate responses | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial magnetic stimulation, Theta Burst, Depression, Tobacco, suicide ideation