Antidepressive Effect on 5 Herz (Hz) rTMS Over Dorsomedial Prefrontal Cortex and Left Dorsolateral Prefrontal Cortex

NCT ID: NCT03571412

Last Updated: 2019-04-16

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

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-08

Study Completion Date

2017-09-01

Brief Summary

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This study evaluates the efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) over Left Dorsolateral Prefrontal Cortex and Dorsomedial Prefrontal Cortex on Major Depressive Disorder (MDD).

Detailed Description

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Major Depressive Disorder (MDD) affects a significant percentage of the national population (17-20%) in 2:1 ratio in women compared to men. Repetitive Transcranial Magnetic Stimulation (rTMS) is an effective neuromodulation technique for the treatment of Major Depressive Disorder and it has demonstrated favorable clinical effects when applied over the Left Dorsolateral Prefrontal Cortex (LDLPFC); however there is evidence that other areas of the prefrontal cortex such as the Dorsomedial Prefrontal Cortex (DMPFC) could be ideal for rTMS treatment targets during the presence of MDD, given its association with deficient cognitive processes during the course of the illness. There is also evidence of the use of 5Hz frequency with the same clinical effectiveness from other frequencies such as 10 Hz and 20 Hz when applied to the LDLPFC. However, there are no current research that have addressed the use of this frequency on DMPFC.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The purpose to this study is to valuate the clinical effects of 5Hz rTMS over Left Dorsolateral Prefrontal Cortex and Dorsomedial Prefrontal Cortex
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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5Hz Left Dorsolateral Prefrontal Cortex

This group will receive 5Hz Left Dorsolateral Prefrontal Cortex repetitive Transcranial Magnetic Stimulation. Once a day on monday to friday. Until complete 15 sessions.After complete acute phase intervention (15 sessions) subject will have a 5 week clinical follow up.

Group Type EXPERIMENTAL

repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Subject will receive 5Hz LDLPFC or 5Hz DMPFC rTMS

5Hz Dorsomedial Prefrontal Cortex

This group will receive 5Hz Dorsomedial Prefrontal Cortex Transcranial Magnetic Stimulation, once a day on monday to friday. Until complete 15 sessions.After complete acute phase intervention (15 sessions) subject will have a 5 week clinical follow up.

Group Type EXPERIMENTAL

repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Subject will receive 5Hz LDLPFC or 5Hz DMPFC rTMS

Interventions

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repetitive Transcranial Magnetic Stimulation

Subject will receive 5Hz LDLPFC or 5Hz DMPFC rTMS

Intervention Type DEVICE

Other Intervention Names

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Transcranial Magnetic Stimulation

Eligibility Criteria

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Inclusion Criteria

* 18-45 years old.
* Meet DSM 5 (Diagnostic and Statistical Manual, 5 edition) diagnostic criteria for Major Depressive Disorder.
* Score \>17 in Hamilton Depression Rating Scale.

Exclusion Criteria

* Subjects with diagnose of Psychotic Depression, Schizophrenia, Bipolar Disorder, Post Traumatic Stress Disorder.
* Subjects with epilepsy or presence of paroxysms during the EEG.
* Subjects with previous history of traumatic brain injury, metal plates in the skull, cochlear devices, infusion devices such as insulin pumps.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Autonoma de Queretaro

OTHER

Sponsor Role lead

Responsible Party

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Dr. Julian Reyes López

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julian Reyes, PhD

Role: STUDY_DIRECTOR

Universidad Autónoma de Querétaro

Other Identifiers

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01-05/05/2016

Identifier Type: -

Identifier Source: org_study_id

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