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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05694754
• Other study ID #: 21-03-2022
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: January 2023
• Source: Universidad Autonoma de Queretaro
• Contact: sofia cañizares Gómez, master
• Phone: (442)1910317
• Email: soficanizares[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 31, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Smoking Reduction

Intervention

Device:
• Theta Burst Transcranial Magnetic Stimulation
Magventure MagPro R30 stimulation Device, MCF-B70 stimulation Coill

Locations

Country	Name	City	State
Mexico	Sofia Cañizares Gómez	Querétaro City	Querétaro

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Julian Reyes López

Country where clinical trial is conducted

Mexico, 

References & Publications (9)

Ahern E, Kinsella S, Semkovska M. Clinical efficacy and economic evaluation of online cognitive behavioral therapy for major depressive disorder: a systematic review and meta-analysis. Expert Rev Pharmacoecon Outcomes Res. 2018 Feb;18(1):25-41. doi: 10.10 — View Citation

Arikan MK, Gunver MG, Tarhan N, Metin B. High-Gamma: A biological marker for suicide attempt in patients with depression. J Affect Disord. 2019 Jul 1;254:1-6. doi: 10.1016/j.jad.2019.05.007. Epub 2019 May 6. — View Citation

Baeken C, Marinazzo D, Everaert H, Wu GR, Van Hove C, Audenaert K, Goethals I, De Vos F, Peremans K, De Raedt R. The Impact of Accelerated HF-rTMS on the Subgenual Anterior Cingulate Cortex in Refractory Unipolar Major Depression: Insights From 18FDG PET — View Citation

Czeisler ME, Lane RI, Petrosky E, Wiley JF, Christensen A, Njai R, Weaver MD, Robbins R, Facer-Childs ER, Barger LK, Czeisler CA, Howard ME, Rajaratnam SMW. Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic - United States, — View Citation

Filipcic I, Milovac Z, Sucic S, Gajsak T, Filipcic IS, Ivezic E, Aljinovic V, Orgulan I, Penic SZ, Bajic Z. Efficacy, Safety and Tolerability of Augmentative rTMS in Treatment of Major Depressive Disorder (MDD): A Prospective Cohort Study in Croatia. Psyc — View Citation

Fluharty M, Taylor AE, Grabski M, Munafo MR. The Association of Cigarette Smoking With Depression and Anxiety: A Systematic Review. Nicotine Tob Res. 2017 Jan;19(1):3-13. doi: 10.1093/ntr/ntw140. Epub 2016 May 19. — View Citation

Garcia-Gomez L, Hernandez-Perez A, Noe-Diaz V, Riesco-Miranda JA, Jimenez-Ruiz C. SMOKING CESSATION TREATMENTS: CURRENT PSYCHOLOGICAL AND PHARMACOLOGICAL OPTIONS. Rev Invest Clin. 2019;71(1):7-16. doi: 10.24875/RIC.18002629. — View Citation

Mahoney JJ 3rd, Hanlon CA, Marshalek PJ, Rezai AR, Krinke L. Transcranial magnetic stimulation, deep brain stimulation, and other forms of neuromodulation for substance use disorders: Review of modalities and implications for treatment. J Neurol Sci. 2020 — View Citation

Picciotto MR, Mineur YS. Molecules and circuits involved in nicotine addiction: The many faces of smoking. Neuropharmacology. 2014 Jan;76 Pt B(0 0):545-53. doi: 10.1016/j.neuropharm.2013.04.028. Epub 2013 Apr 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Hamilton Rating Depression Scale (HDRS)	21 item, Clinical assessment of depressive symptoms	10 minutes
Primary	Montgomery-Asberg Rating Depression Scale (MADRS)	10 ítem Clinical assessment of the principal depressive symptoms	10 minutes
Primary	Hamilton Anxiety Rating Scale (HARS)	14 Ítem clinical scale for rating anxiety symptoms.	10 minutes
Primary	Beck Depression Invetory (BDI)	it´s a 21 ítem self evaluated symptomatology of depression	10 minutes
Primary	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
Primary	Plutchik Risk Suicide Scale	it´s a 26 ítem self-reported scale that assess the intensity of suicidal ideation	10 minutes
Primary	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
Primary	Wisconsin Card Sorting Test (WCST)	is a neuropsychological test that assess cognitive flexibility	20 minutes
Primary	Stop Signal Task	is a unique versión of a classic approach to measuring response inhibition	25 minutes
Secondary	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