Transcranial Magnetic Stimulation on Dorsomedial Prefrontal Cortex in Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

— TMS&BPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03832777
• Other study ID #: 04-01/02/2018
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: January 2019
• Source: Universidad Autonoma de Queretaro
• Contact: Angel R Calderón-Moctezuma, Physician
• Phone: +52 9511047213
• Email: angel_roman_cm[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Disease
• Personality Disorders

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
Subjects will receive both active and placebo rTMS, in a crossover modality.

Locations

Country	Name	City	State
Mexico	Autonomous University of Queretaro	Querétaro City	Querétaro

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Queretaro

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Borderline Symptoms List (BSL)	BSL is a 23 item scale that evaluates the general symptoms and 11 items with behavioural evaluation of BPD.	6 weeks
Primary	Global Clinical Impression of BPD (GCI-BPD)	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
Primary	Borderline Evaluation of Severity Over Time (BEST)	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	Hamilton Depression Rating Scale (HDRS)	HDRS is a 21 item scale that evaluates the severity of depressive symptoms in patients.	6 weeks
Secondary	Hamilton Anxiety Rating Scale (HARS)	HARS is a 14 items rating scale that evaluates the severity of anxiety symptoms in patients.	6 weeks
Secondary	Barratt Impulsivity Scale (BIS-11)	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