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

Primary Purpose

Borderline Personality Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sponsored by
Universidad Autonoma de Queretaro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline Personality Disorder, Personality Disorders

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Autonomous University of QueretaroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

5 Hz Stimulation

Placebo Stimulation

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hamilton Depression Rating Scale (HDRS)
HDRS is a 21 item scale that evaluates the severity of depressive symptoms in patients.
Hamilton Anxiety Rating Scale (HARS)
HARS is a 14 items rating scale that evaluates the severity of anxiety symptoms in patients.
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 .

Full Information

First Posted
February 5, 2019
Last Updated
February 12, 2019
Sponsor
Universidad Autonoma de Queretaro
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1. Study Identification

Unique Protocol Identification Number
NCT03832777
Brief Title
Transcranial Magnetic Stimulation on Dorsomedial Prefrontal Cortex in Borderline Personality Disorder
Acronym
TMS&BPD
Official Title
Effect of Transcranial Magnetic Stimulation on Dorsomedial Cortex in Clinical and Neuropsychological Variables in Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Queretaro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Borderline Personality Disorder, Personality Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Participant
Masking Description
Single
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5 Hz Stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Stimulation
Arm Type
Placebo Comparator
Arm Description
This group will receive the Sham modality simulating 1500 pulses of 5Hz Transcranial Magnetic Stimulation for 15 sessions, one per weekday.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Other Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
Subjects will receive both active and placebo rTMS, in a crossover modality.
Primary Outcome Measure Information:
Title
Borderline Symptoms List (BSL)
Description
BSL is a 23 item scale that evaluates the general symptoms and 11 items with behavioural evaluation of BPD.
Time Frame
6 weeks
Title
Global Clinical Impression of BPD (GCI-BPD)
Description
CGI-BPD is a 10 item evaluation that rates the severity of BPD distributed in 9 neuropsychological domains with a final global score.
Time Frame
6 weeks
Title
Borderline Evaluation of Severity Over Time (BEST)
Description
BEST is a 15 item scale that evaluates the severity in this pathology according to 3 areas: thoughts, emotions and typical behaviours.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HDRS)
Description
HDRS is a 21 item scale that evaluates the severity of depressive symptoms in patients.
Time Frame
6 weeks
Title
Hamilton Anxiety Rating Scale (HARS)
Description
HARS is a 14 items rating scale that evaluates the severity of anxiety symptoms in patients.
Time Frame
6 weeks
Title
Barratt Impulsivity Scale (BIS-11)
Description
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 .
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angel R Calderón-Moctezuma, Physician
Phone
+52 9511047213
Email
angel_roman_cm@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian V Reyes-López, Psychiatrist
Organizational Affiliation
Faculty of Medicine, Autonomous University of Queretaro
Official's Role
Study Director
Facility Information:
Facility Name
Autonomous University of Queretaro
City
Querétaro City
State/Province
Querétaro
ZIP/Postal Code
76176
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel R Calderón-Moctezuma, Physician
Phone
+529511047213
Email
angel_roman_cm@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32876128
Citation
Calderon-Moctezuma AR, Reyes-Lopez JV, Rodriguez-Valdes R, Barbosa-Luna M, Ricardo-Garcell J, Espino-Cortes M, Hernandez-Chan N, Garcia-Noguez L, Roque-Roque G, Trejo-Cruz G, Canizares-Gomez S, Hernandez-Montiel H. Improvement in borderline personality disorder symptomatology after repetitive transcranial magnetic stimulation of the dorsomedial prefrontal cortex: preliminary results. Braz J Psychiatry. 2021 Feb 1;43(1):65-69. doi: 10.1590/1516-4446-2019-0591. eCollection 2020.
Results Reference
derived

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Transcranial Magnetic Stimulation on Dorsomedial Prefrontal Cortex in Borderline Personality Disorder

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