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

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ClinicalTrials.gov Identifier: NCT03832777
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Julian Reyes López, Universidad Autonoma de Queretaro

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

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Device: Repetitive Transcranial Magnetic Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Single (Participant)
Masking Description: Single
Primary Purpose: Treatment
Official Title: Effect of Transcranial Magnetic Stimulation on Dorsomedial Cortex in Clinical and Neuropsychological Variables in Borderline Personality Disorder
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : January 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Transcranial Magnetic Stimulation




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 Outcome Measures :
  1. Hamilton Depression Rating Scale (HDRS) [ Time Frame: 6 weeks ]
    HDRS is a 21 item scale that evaluates the severity of depressive symptoms in patients.

  2. 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.

  3. 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 .



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832777


Contacts
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Contact: Angel R Calderón-Moctezuma, Physician +52 9511047213 angel_roman_cm@hotmail.com

Locations
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Mexico
Autonomous University of Queretaro Recruiting
Querétaro City, Querétaro, Mexico, 76176
Contact: Angel R Calderón-Moctezuma, Physician    +529511047213    angel_roman_cm@hotmail.com   
Sponsors and Collaborators
Universidad Autonoma de Queretaro
Investigators
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Study Director: Julian V Reyes-López, Psychiatrist Faculty of Medicine, Autonomous University of Queretaro

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Responsible Party: Dr. Julian Reyes López, Professor, Universidad Autonoma de Queretaro
ClinicalTrials.gov Identifier: NCT03832777     History of Changes
Other Study ID Numbers: 04-01/02/2018
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Julian Reyes López, Universidad Autonoma de Queretaro:
Borderline Personality Disorder
Personality Disorders

Additional relevant MeSH terms:
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Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders