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

January 12, 2023 updated by: Dr. Julian Reyes López

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 76170
        • Recruiting
        • Sofia Cañizares Gómez
        • Contact:
        • Contact:
        • Principal Investigator:
          • julian V. Reyes López, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 session
Participants will receive 1 session from monday to friday,during 4 weeks, with 600 total pulses per session
Device: Theta Burst Transcranial Magnetic Stimulation
Magventure MagPro R30 stimulation Device, MCF-B70 stimulation Coill
Experimental: 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
Device: Theta Burst Transcranial Magnetic Stimulation
Magventure MagPro R30 stimulation Device, MCF-B70 stimulation Coill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MINI Neuropsychiatric Interview
Time Frame: 15 minutes
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
Time Frame: 5 minutes
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
Time Frame: 5 minutes
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
Time Frame: 8 minutes
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)
Time Frame: 10 minutes
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)
Time Frame: 5 minutes
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)
Time Frame: 8 minutes
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
Time Frame: 10 minutes
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
Time Frame: 1 minute
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)
Time Frame: 10 minutes
21 item, Clinical assessment of depressive symptoms
10 minutes
Montgomery-Asberg Rating Depression Scale (MADRS)
Time Frame: 10 minutes
10 ítem Clinical assessment of the principal depressive symptoms
10 minutes
Hamilton Anxiety Rating Scale (HARS)
Time Frame: 10 minutes
14 Ítem clinical scale for rating anxiety symptoms.
10 minutes
Beck Depression Invetory (BDI)
Time Frame: 10 minutes
it´s a 21 ítem self evaluated symptomatology of depression
10 minutes
Beck Hopelesness Scale (BHS)
Time Frame: 10 minutes
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
Time Frame: 10 minutes
it´s a 26 ítem self-reported scale that assess the intensity of suicidal ideation
10 minutes
Beck suicidal ideation scale (BSIS)
Time Frame: 10 minutes
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)
Time Frame: 20 minutes
is a neuropsychological test that assess cognitive flexibility
20 minutes
Stop Signal Task
Time Frame: 25 minutes
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
Time Frame: 10 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Julian Reyes López

Investigators

  • Study Director: Julian V. Reyes López, PhD, Universidad Autónoma de Querétaro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

December 1, 2022

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-03-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking Reduction

Clinical Trials on Theta Burst Transcranial Magnetic Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe