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

I

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Status

Unknown

Conditions

Borderline Personality Disorder

Treatments

Device: repeated transcranial magnetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04722510
CEI/C/088/2016

Details and patient eligibility

About

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.

Enrollment

34 estimated patients

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

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.).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 1 patient group

Effect of repeated TMS on aggressive impulse behavior in patients with BPD.
Experimental group
Description:
A protocol of 15 sessions of repeated Transcranial Magnetic Stimulation at 1 Hz on right dorsolateral prefrontal cortex.
Treatment:
Device: repeated transcranial magnetic stimulation

Trial contacts and locations

1

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Central trial contact

ANDRES RODRIGUEZ-DELGADO, MD

Data sourced from clinicaltrials.gov

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