Transcranial Magnetic Stimulation on Dorsomedial Prefrontal Cortex in Borderline Personality Disorder (TMS&BPD)

February 12, 2019 updated by: Dr. Julian Reyes López, Universidad Autónoma de Querétaro

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

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 Locations

  • Mexico
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 76176
        • Recruiting
        • Autonomous University of Queretaro
        • Contact:

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:

  • 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).

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: Repetitive Transcranial Magnetic Stimulation
Subjects will receive both active and placebo rTMS, in a crossover modality.
Other Names:
  • Transcranial Magnetic Stimulation
Placebo Comparator: Placebo Stimulation
This group will receive the Sham modality simulating 1500 pulses of 5Hz Transcranial Magnetic Stimulation for 15 sessions, one per weekday.
Device: Repetitive Transcranial Magnetic Stimulation
Subjects will receive both active and placebo rTMS, in a crossover modality.
Other Names:
  • Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Depression Rating Scale (HDRS)
Time Frame: 6 weeks
HDRS is a 21 item scale that evaluates the severity of depressive symptoms in patients.
6 weeks
Hamilton Anxiety Rating Scale (HARS)
Time Frame: 6 weeks
HARS is a 14 items rating scale that evaluates the severity of anxiety symptoms in patients.
6 weeks
Barratt Impulsivity Scale (BIS-11)
Time Frame: 6 weeks
The Barratt Impulsiveness Scale is a questionnaire designed to assess the personality / behavioral construct of impulsiveness; composed of 30 items describing common impulsive or non-impulsive (for reversed scored items) behaviors and preferences .
6 weeks

Collaborators and Investigators

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

Sponsor

Universidad Autónoma de Querétaro

Investigators

  • Study Director: Julian V Reyes-López, Psychiatrist, Faculty of Medicine, Autonomous University of Queretaro

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)

March 5, 2018

Primary Completion (Actual)

January 30, 2019

Study Completion (Anticipated)

August 30, 2019

Study Registration Dates

First Submitted

February 5, 2019

First Submitted That Met QC Criteria

February 5, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-01/02/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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 Borderline Personality Disorder

Clinical Trials on Repetitive Transcranial Magnetic Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe