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

NCT04722510 | Unknown DMC

• 1 other identifier: CEI/C/088/2016
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Effect of repeated TMS on aggressive impulse behavior in patients with BPD.

EXPERIMENTAL

A protocol of 15 sessions of repeated Transcranial Magnetic Stimulation at 1 Hz on right dorsolateral prefrontal cortex.

Device: repeated transcranial magnetic stimulation

Interventions

repeated transcranial magnetic stimulation DEVICE

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.

Effect of repeated TMS on aggressive impulse behavior in patients with BPD.

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente: lead

Study Sites (1)

Instituto Nacional de Psiquiatria Ramon de la Fuente Muñiz

Mexico City, Mexico City, 14370, Mexico

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• JORGE GONZALEZ-OLVERA, PHD

  Instituto Nacional de Psiquiatría Ramon de la Fuente Muñiz

  STUDY CHAIR

Central Study Contacts

ANDRES RODRIGUEZ-DELGADO, MD

CONTACT

525532250714; andres_rode@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 25, 2021
• Study Start: January 21, 2021
• Primary Completion: January 21, 2021
• Study Completion: January 21, 2021
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

ME (1)