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

Sponsor
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente (Other)
Overall Status
Recruiting
CT.gov ID
NCT04722510
Collaborator
(none)
34
1
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: repeated transcranial magnetic stimulation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Randomized clinical trialRandomized clinical trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Repeated Transcranial Magnetic Stimulation on Aggressive Impulsive Behavior in Patients With Borderline Personality Disorder in a Social Exclusion Paradigm.
Actual Study Start Date :
Jan 21, 2021
Anticipated Primary Completion Date :
Jan 21, 2021
Anticipated Study Completion Date :
Jan 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Maneuver effect [3 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto Nacional de Psiquiatria Ramon de la Fuente Muñiz Mexico City DF Mexico 14370

Sponsors and Collaborators

  • Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Investigators

  • Study Chair: JORGE GONZALEZ-OLVERA, PHD, INSTITUTO NACIONAL DE PSIQUIATRÍA RAMON DE LA FUENTE MUÑIZ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
ClinicalTrials.gov Identifier:
NCT04722510
Other Study ID Numbers:
  • CEI/C/088/2016
First Posted:
Jan 25, 2021
Last Update Posted:
Jan 25, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2021