Clinical trial NCT03832777: Transcranial Magnetic Stimulation on Dorsomedial Prefrontal Cortex in Borderline Personality Disorder
Official title: Effect of Transcranial Magnetic Stimulation on Dorsomedial Cortex in Clinical and Neuropsychological Variables in Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Borderline Personality Disorder
Personality Disorders
Lead sponsor: Universidad Autonoma de Queretaro
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Borderline Symptoms List (BSL)
timeFrame: 6 weeks
measure: Global Clinical Impression of BPD (GCI-BPD)
timeFrame: 6 weeks
measure: Borderline Evaluation of Severity Over Time (BEST)
timeFrame: 6 weeks
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: 6 weeks
measure: Hamilton Anxiety Rating Scale (HARS)
timeFrame: 6 weeks
measure: Barratt Impulsivity Scale (BIS-11)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Querétaro City
country: Mexico
facility: Autonomous University of Queretaro
state: Querétaro
Study officials:
affiliation: Faculty of Medicine, Autonomous University of Queretaro
name: Julian V Reyes-López, Psychiatrist
role: STUDY_DIRECTOR
References:
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.