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

NCT ID: NCT04722510

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-21
• Study Completion Date: 2021-01-21

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

repeated transcranial magnetic stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JORGE GONZALEZ-OLVERA, PHD

Role: STUDY_CHAIR

Instituto Nacional de Psiquiatría Ramon de la Fuente Muñiz

Locations

Instituto Nacional de Psiquiatria Ramon de la Fuente Muñiz

Mexico City, Mexico City, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

ANDRES RODRIGUEZ-DELGADO, MD

Role: CONTACT

andres_rode@hotmail.com

525532250714

Facility Contacts

Jorge J Gonzalez Olvera, MD PhD

Role: primary

jjgonz@gmail.com

+5215515107370

Andres Rodriguez Delgado, MD

Role: backup

andres_rode@hotmail.com

+525532250714

Other Identifiers

CEI/C/088/2016

Identifier Type: -

Identifier Source: org_study_id