Transcranial Magnetic Stimulation on Dorsomedial Prefrontal Cortex in Borderline Personality Disorder

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

2018-03-05

Study Completion Date

2019-08-30

Brief Summary

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This study evaluates the effect of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) on Dorsomedial Prefrontal Cortex on Borderline Personality Disorder (BPD).

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Detailed Description

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Borderline Personality Disorder (BPD) is a mental illness with a high worldwide prevalence and economic costs, and is characterized with impulsiveness, both interpersonal relationships and emotional disturbance. Symptoms are related to hypofunction of frontal areas like Dorsomedial Prefrontal Cortex (DMPFC). Psychotherapy is the base treatment in this disease, but economic costs and long-time therapy have made difficult the attachment. Repetitive Transcranial Magnetic Stimulation(rTMS), authorized by Food and Drug Administration (FDA) on Major Depressive Disorder (MDD) treatment has proven good results in previous works in BPD clinical characteristics on both dorsolateral prefrontal cortex (DLPFC) and enhancement in depressive symptoms stimulating DMPFC in high frequency. However, there are no current research that have addressed the use of low-frequency on this anatomical area.

Conditions

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Borderline Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The aim of this study is to evaluate the clinical effects of 5Hz rTMS over Dorsomedial Prefrontal Cortex on an active versus placebo modality stimulation.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Single

Study Groups

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5 Hz Stimulation

This group will receive 5Hz (Hertz) Dorsomedial Prefrontal Cortex repetitive Transcranial Magnetic Stimulation with 1500 pulses per session, once per weekday, with a final result of 15 sessions in this modality.

Group Type ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Subjects will receive both active and placebo rTMS, in a crossover modality.

Placebo Stimulation

This group will receive the Sham modality simulating 1500 pulses of 5Hz Transcranial Magnetic Stimulation for 15 sessions, one per weekday.

Group Type PLACEBO_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Subjects will receive both active and placebo rTMS, in a crossover modality.

Interventions

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Repetitive Transcranial Magnetic Stimulation

Subjects will receive both active and placebo rTMS, in a crossover modality.

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, 5th edition) diagnostic criteria for Borderline Personality Disorder.
* Score of \>7 in the Diagnostic Interview for Borderline (Revised version, DIB-R)
* All patients must have follow-up psychotherapy of at least one month.
* No changes on pharmacological treatment within the last month.
* Patients must provide their oral and written informed consent.

Exclusion Criteria

* Subjects with history of traumatic brain injury with loss of consciousness.
* Subjects with intracranial metallic objects or metal plates in the skull.
* Subjects diagnosed with uncontrolled chronic (for example: hypertension, diabetes) or neurological diseases.
* Comorbidity with other mental illness. (Except Depressive symptoms and Anxiety Disorders).
* Presence of psychotic symptoms.
* Alterations in the electroencephalogram (epileptiform activity).
* Self injury or suicidal attempts in less than 2 weeks (depends on the severity and deepness).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No