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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.

Primary Purpose

Borderline Personality Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

repeated transcranial magnetic stimulation

About this trial

This is an interventional treatment trial for Borderline Personality Disorder

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts 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.).

Sites / Locations

Instituto Nacional de Psiquiatria Ramon de la Fuente MuñizRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04722510

First Posted

January 21, 2021

Last Updated

January 21, 2021

Sponsor

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

1. Study Identification

Unique Protocol Identification Number

NCT04722510

Brief Title

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 21, 2021 (Actual)

Primary Completion Date

January 21, 2021 (Anticipated)

Study Completion Date

January 21, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Borderline Personality Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Randomized clinical trial

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

repeated transcranial magnetic stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Maneuver effect

Description

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

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.).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ANDRES RODRIGUEZ-DELGADO, MD

Phone

525532250714

andres_rode@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JORGE GONZALEZ-OLVERA, PHD

Organizational Affiliation

INSTITUTO NACIONAL DE PSIQUIATRÍA RAMON DE LA FUENTE MUÑIZ

Official's Role

Study Chair

Facility Information:

Facility Name

Instituto Nacional de Psiquiatria Ramon de la Fuente Muñiz

City

Mexico City

State/Province

ZIP/Postal Code

14370

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jorge J Gonzalez Olvera, MD PhD

Phone

+5215515107370

jjgonz@gmail.com

First Name & Middle Initial & Last Name & Degree

Andres Rodriguez Delgado, MD

Phone

+525532250714

andres_rode@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

In case of being requested

Learn more about this trial

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

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