Effect of Repeated Transcranial Magnetic Stimulation on Aggressive Impulsive Behavior in Patients With Borderline Personality Disorder in a Social Exclusion Paradigm.

Borderline Personality Disorder Clinical Trial

Official title:

Effect of Repeated Transcranial Magnetic Stimulation on Aggressive Impulsive Behavior in Patients With Borderline Personality Disorder in a Social Exclusion Paradigm.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04722510
• Other study ID #: CEI/C/088/2016
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: January 21, 2021

Study information

• Verified date: January 2021
• Source: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
• Contact: ANDRES RODRIGUEZ-DELGADO, MD
• Phone: 525532250714
• Email: andres_rode[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with a main diagnosis of borderline personality disorder will be recruited and will be randomized for the application of low frequency repeated transcranial magnetic stimulation (rTMS) protol or sham rTMS protocol. A pre-treatment and post-treatment measurement of the severity of BPD symptoms, impulsivity, and aggressive behavior will be carried out in all participants using self-administered questionnaires. All participants will be asked to participate in a passing ball game (Cyberball) with the intention of investigating aspects related to social inclusion / exclusion and measurements will be made regarding planning using the maze test. Participation in the Cyberball and the assessment of the planning will be carried out before and after the application of the treatment protocol.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: January 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• Outpatient consultant in the Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz.
• Main diagnosis of borderline personality disorder according to DSM-IV-TR.
• In the case of having some type of pharmacological treatment using SSRIs, antipsychotics and / or anticonvulsants, this should be maintained without modifications for at least 2 weeks prior to the start of the study and during the follow-up period.
• Comorbidity with some other personality disorder according to the SCID-II, with the exception of antisocial personality disorder.
• Acceptance of participation in the study by signing the informed consent.

Exclusion Criteria:

• Subjects who did not agree to participate.
• Diagnosis of current antisocial personality disorder, bipolar disorder, psychotic disorders, severe major depressive episode, substance use disorder (except nicotine), and post-traumatic stress disorder.
• Presence of any comorbid neurological disorder.
• Diagnosis of intellectual disability.
• Subjects in whom the use of rTMS is contraindicated: history of seizures, pregnancy, presence of pacemaker, heart disease, and presence of a metallic object.
• Electroencephalographic evidence of some type of abnormality in the excitability of the central nervous system (dysrhythmias, paroxysmal activity, graphical elements suggestive of epileptic activity, etc.).

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Impulsive Behavior
• Personality Disorders

Intervention

Device:
• repeated transcranial magnetic stimulation
Transcranial magnetic stimulation is a non-invasive brain modulation technique that has proven to be a useful study and treatment tool in neuropsychiatric disorders. This technique allows to increase (with high frequency protocol, > 1 Hz) or decrease (with low frecuency protocols, 1 hz or less) neuronal excitability in a focused cortical area.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Psiquiatria Ramon de la Fuente Muñiz	Mexico City	DF

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maneuver effect	To determine whether the application of a series of 15 sessions of low-frequency (1 Hz) repeated Transcranial Magnetic Stimulation applied to the right dorsolateral prefrontal cortex reduces the severity of impulse agressive behavior in subjects with BPD as measured by the impulsive / premeditated aggression scale.	3 weeks