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Clinical Trials/NCT03832777
NCT03832777
Unknown
Not Applicable

Effect of Transcranial Magnetic Stimulation on Dorsomedial Cortex in Clinical and Neuropsychological Variables in Borderline Personality Disorder

Universidad Autonoma de Queretaro1 site in 1 country20 target enrollmentMarch 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Borderline Personality Disorder
Sponsor
Universidad Autonoma de Queretaro
Enrollment
20
Locations
1
Primary Endpoint
Borderline Symptoms List (BSL)
Last Updated
7 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 5, 2018
End Date
August 30, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Julian Reyes López

Professor

Universidad Autonoma de Queretaro

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Borderline Symptoms List (BSL)

Time Frame: 6 weeks

BSL is a 23 item scale that evaluates the general symptoms and 11 items with behavioural evaluation of BPD.

Global Clinical Impression of BPD (GCI-BPD)

Time Frame: 6 weeks

CGI-BPD is a 10 item evaluation that rates the severity of BPD distributed in 9 neuropsychological domains with a final global score.

Borderline Evaluation of Severity Over Time (BEST)

Time Frame: 6 weeks

BEST is a 15 item scale that evaluates the severity in this pathology according to 3 areas: thoughts, emotions and typical behaviours.

Secondary Outcomes

  • Hamilton Anxiety Rating Scale (HARS)(6 weeks)
  • Barratt Impulsivity Scale (BIS-11)(6 weeks)
  • Hamilton Depression Rating Scale (HDRS)(6 weeks)

Study Sites (1)

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