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

NCT ID: NCT05694754

Last Updated: 2023-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-01-31

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.

Conditions

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Major Depressive Disorder Smoking Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Triple blind study

Study Groups

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1 session

Participants will receive 1 session from monday to friday,during 4 weeks, with 600 total pulses per session

Group Type EXPERIMENTAL

Theta Burst Transcranial Magnetic Stimulation

Intervention Type DEVICE

Magventure MagPro R30 stimulation Device, MCF-B70 stimulation Coill

3 sessions

Participants will receive 3 sessions from monday to friday,during 4 weeks, with 1800 total pulses per session with a 10 minutes rest interval

Group Type EXPERIMENTAL

Theta Burst Transcranial Magnetic Stimulation

Intervention Type DEVICE

Magventure MagPro R30 stimulation Device, MCF-B70 stimulation Coill

Interventions

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Theta Burst Transcranial Magnetic Stimulation

Magventure MagPro R30 stimulation Device, MCF-B70 stimulation Coill

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Julian Reyes López

OTHER

Sponsor Role lead

Responsible Party

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Dr. Julian Reyes López

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Julian V. Reyes López, PhD

Role: STUDY_DIRECTOR

Universidad Autónoma de Querétaro

Locations

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Sofia Cañizares Gómez

Querétaro City, Querétaro, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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sofia cañizares Gómez, master

Role: CONTACT

(442)1910317

Gerardo Trejo Cruz, master

Role: CONTACT

(442)2848849

Facility Contacts

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sofia cañizares gómez, master

Role: primary

00524421910317

gerardo trejo cruz, master

Role: backup

00524422848849

References

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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.

Reference Type RESULT
PMID: 27199385 (View on PubMed)

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.

Reference Type RESULT
PMID: 23632083 (View on PubMed)

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.

Reference Type RESULT
PMID: 29145746 (View on PubMed)

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.

Reference Type RESULT
PMID: 30810545 (View on PubMed)

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.

Reference Type RESULT
PMID: 25744500 (View on PubMed)

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.

Reference Type RESULT
PMID: 31082626 (View on PubMed)

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.

Reference Type RESULT
PMID: 33002757 (View on PubMed)

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.

Reference Type RESULT
PMID: 28291972 (View on PubMed)

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.

Reference Type RESULT
PMID: 32790653 (View on PubMed)

Other Identifiers

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21-03-2022

Identifier Type: -

Identifier Source: org_study_id

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