Back to resultsTranscranial Magnetic Stimulation Theta Burst (TMS), Depression and Smoking.
Primary Purpose
Major Depressive Disorder, Smoking Reduction
Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Theta Burst Transcranial Magnetic Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Transcranial magnetic stimulation, Theta Burst, Depression, Tobacco, suicide ideation
Eligibility Criteria
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.
Sites / Locations
- Sofia Cañizares GómezRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1 session
3 sessions
Arm Description
Participants will receive 1 session from monday to friday,during 4 weeks, with 600 total pulses per session
Participants will receive 3 sessions from monday to friday,during 4 weeks, with 1800 total pulses per session with a 10 minutes rest interval
Outcomes
Primary Outcome Measures
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
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.
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
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.
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.
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
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
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
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.
Hamilton Rating Depression Scale (HDRS)
21 item, Clinical assessment of depressive symptoms
Montgomery-Asberg Rating Depression Scale (MADRS)
10 ítem Clinical assessment of the principal depressive symptoms
Hamilton Anxiety Rating Scale (HARS)
14 Ítem clinical scale for rating anxiety symptoms.
Beck Depression Invetory (BDI)
it´s a 21 ítem self evaluated symptomatology of depression
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)
Plutchik Risk Suicide Scale
it´s a 26 ítem self-reported scale that assess the intensity of suicidal ideation
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
Wisconsin Card Sorting Test (WCST)
is a neuropsychological test that assess cognitive flexibility
Stop Signal Task
is a unique versión of a classic approach to measuring response inhibition
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05694754
First Posted
January 12, 2023
Last Updated
January 12, 2023
Sponsor
Dr. Julian Reyes López
1. Study Identification
Unique Protocol Identification Number
NCT05694754
Brief Title
Transcranial Magnetic Stimulation Theta Burst (TMS), Depression and Smoking.
Official Title
Transcranial Magnetic Stimulation and Its Effects on Mayor Depressive Disorder and Smoking Cessation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
January 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Julian Reyes López
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Smoking Reduction
Keywords
Transcranial magnetic stimulation, Theta Burst, Depression, Tobacco, suicide ideation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Triple blind study
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 session
Arm Type
Experimental
Arm Description
Participants will receive 1 session from monday to friday,during 4 weeks, with 600 total pulses per session
Arm Title
3 sessions
Arm Type
Experimental
Arm Description
Participants will receive 3 sessions from monday to friday,during 4 weeks, with 1800 total pulses per session with a 10 minutes rest interval
Intervention Type
Device
Intervention Name(s)
Theta Burst Transcranial Magnetic Stimulation
Intervention Description
Magventure MagPro R30 stimulation Device, MCF-B70 stimulation Coill
Primary Outcome Measure Information:
Title
MINI Neuropsychiatric Interview
Description
It is a short structured diagnostic interview that explores the main psychiatric disorders of Axis I of DSM-IV and ICD-10
Time Frame
15 minutes
Title
Fagerström test
Description
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.
Time Frame
5 minutes
Title
Richmond Test
Description
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
Time Frame
5 minutes
Title
Glover-Nilsson Test
Description
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.
Time Frame
8 minutes
Title
Test of the Unit of the Institute of Public Health of Madrid (UISPM)
Description
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.
Time Frame
10 minutes
Title
Minnesota Nicotine Withdrawal Syndrome Scale (MNWS)
Description
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
Time Frame
5 minutes
Title
Nicotine Craving Questionnaire (CCN)
Description
12-item questionnaire to assess the degree of craving, with five response options ranging from completely disagree 1 to completely agree 5
Time Frame
8 minutes
Title
Paradigm of reactivity to signals and heart rate variability
Description
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
Time Frame
10 minutes
Title
Co-oximetry
Description
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.
Time Frame
1 minute
Title
Hamilton Rating Depression Scale (HDRS)
Description
21 item, Clinical assessment of depressive symptoms
Time Frame
10 minutes
Title
Montgomery-Asberg Rating Depression Scale (MADRS)
Description
10 ítem Clinical assessment of the principal depressive symptoms
Time Frame
10 minutes
Title
Hamilton Anxiety Rating Scale (HARS)
Description
14 Ítem clinical scale for rating anxiety symptoms.
Time Frame
10 minutes
Title
Beck Depression Invetory (BDI)
Description
it´s a 21 ítem self evaluated symptomatology of depression
Time Frame
10 minutes
Title
Beck Hopelesness Scale (BHS)
Description
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)
Time Frame
10 minutes
Title
Plutchik Risk Suicide Scale
Description
it´s a 26 ítem self-reported scale that assess the intensity of suicidal ideation
Time Frame
10 minutes
Title
Beck suicidal ideation scale (BSIS)
Description
is an evaluation of suicidal thinking: is an evaluation of suicidal thinking that helps identify individuals at risk of comitting self harm
Time Frame
10 minutes
Title
Wisconsin Card Sorting Test (WCST)
Description
is a neuropsychological test that assess cognitive flexibility
Time Frame
20 minutes
Title
Stop Signal Task
Description
is a unique versión of a classic approach to measuring response inhibition
Time Frame
25 minutes
Secondary Outcome Measure Information:
Title
Marlowe and Crowne Social Desirability Scale
Description
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
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sofia cañizares Gómez, master
Phone
(442)1910317
Email
soficanizares@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gerardo Trejo Cruz, master
Phone
(442)2848849
Email
gerardotrejocruz@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian V. Reyes López, PhD
Organizational Affiliation
Universidad Autónoma de Querétaro
Official's Role
Study Director
Facility Information:
Facility Name
Sofia Cañizares Gómez
City
Querétaro City
State/Province
Querétaro
ZIP/Postal Code
76170
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sofia cañizares gómez, master
Phone
00524421910317
Email
soficanizares@gmail.com
First Name & Middle Initial & Last Name & Degree
gerardo trejo cruz, master
Phone
00524422848849
Email
gerardotrejocruz@outlook.com
First Name & Middle Initial & Last Name & Degree
julian V. Reyes López, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27199385
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.
Results Reference
result
PubMed Identifier
23632083
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.
Results Reference
result
PubMed Identifier
29145746
Citation
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: 10.1080/14737167.2018.1407245. Epub 2017 Nov 30.
Results Reference
result
PubMed Identifier
30810545
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.
Results Reference
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PubMed Identifier
25744500
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 Brain Imaging. Brain Stimul. 2015 Jul-Aug;8(4):808-15. doi: 10.1016/j.brs.2015.01.415. Epub 2015 Feb 7.
Results Reference
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PubMed Identifier
31082626
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.
Results Reference
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PubMed Identifier
33002757
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 Nov 15;418:117149. doi: 10.1016/j.jns.2020.117149. Epub 2020 Sep 20.
Results Reference
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PubMed Identifier
28291972
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. Psychiatr Danub. 2017 Mar;29(1):31-38. doi: 10.24869/psyd.2017.31.
Results Reference
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PubMed Identifier
32790653
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, June 24-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Aug 14;69(32):1049-1057. doi: 10.15585/mmwr.mm6932a1.
Results Reference
result
Learn more about this trial
Transcranial Magnetic Stimulation Theta Burst (TMS), Depression and Smoking.
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