Transcranial Magnetic Stimulation Theta Burst (TMS), Depression and Smoking.
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable major-depressive-disorder
Started Oct 2021
Shorter than P25 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 12, 2023
CompletedFirst Posted
Study publicly available on registry
January 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedJanuary 23, 2023
January 1, 2023
1.2 years
January 12, 2023
January 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (18)
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 Outcomes (1)
Marlowe and Crowne Social Desirability Scale
10 minutes
Study Arms (2)
1 session
EXPERIMENTALParticipants will receive 1 session from monday to friday,during 4 weeks, with 600 total pulses per session
3 sessions
EXPERIMENTALParticipants will receive 3 sessions from monday to friday,during 4 weeks, with 1800 total pulses per session with a 10 minutes rest interval
Interventions
Magventure MagPro R30 stimulation Device, MCF-B70 stimulation Coill
Eligibility Criteria
You may qualify if:
- With dependence on tobacco use, with depressive symptomatology, that they agree to sign the informed consent letter.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sofia Cañizares Gómez
Querétaro City, Querétaro, 76170, Mexico
Related Publications (9)
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.
PMID: 27199385RESULTPicciotto 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.
PMID: 23632083RESULTAhern 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: 10.1080/14737167.2018.1407245. Epub 2017 Nov 30.
PMID: 29145746RESULTGarcia-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.
PMID: 30810545RESULTBaeken 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 Brain Imaging. Brain Stimul. 2015 Jul-Aug;8(4):808-15. doi: 10.1016/j.brs.2015.01.415. Epub 2015 Feb 7.
PMID: 25744500RESULTArikan 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.
PMID: 31082626RESULTMahoney 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 Nov 15;418:117149. doi: 10.1016/j.jns.2020.117149. Epub 2020 Sep 20.
PMID: 33002757RESULTFilipcic 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. Psychiatr Danub. 2017 Mar;29(1):31-38. doi: 10.24869/psyd.2017.31.
PMID: 28291972RESULTCzeisler 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, June 24-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Aug 14;69(32):1049-1057. doi: 10.15585/mmwr.mm6932a1.
PMID: 32790653RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Julian V. Reyes López, PhD
Universidad Autónoma de Querétaro
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Triple blind study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 12, 2023
First Posted
January 23, 2023
Study Start
October 1, 2021
Primary Completion
December 1, 2022
Study Completion
January 31, 2023
Last Updated
January 23, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share