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

Universidad Autonoma de Queretaro

Status: Unknown

Conditions: Borderline Personality Disorder

Treatments: Device: Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03832777

04-01/02/2018

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

20 participants in 2 patient groups, including a placebo group

5 Hz Stimulation

Active Comparator group

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

Placebo Stimulation

Placebo Comparator group

Description:

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

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation