Clinical trial NCT04722510: Effect of Repeated Transcranial Magnetic Stimulation on Aggressive Impulsive Behavior in Patients With Borderline Personality Disorder in a Social Exclusion Paradigm.
Official title: Effect of Repeated Transcranial Magnetic Stimulation on Aggressive Impulsive Behavior in Patients With Borderline Personality Disorder in a Social Exclusion Paradigm.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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.


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.).

Primary outcomes:
measure: Maneuver effect
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Psiquiatria Ramon de la Fuente Muñiz
state: DF
Study officials:
affiliation: Instituto Nacional de Psiquiatría Ramon de la Fuente Muñiz
name: JORGE GONZALEZ-OLVERA, PHD
role: STUDY_CHAIR
References: