NCT03832777

Brief Summary

This study evaluates the effect of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) on Dorsomedial Prefrontal Cortex on Borderline Personality Disorder (BPD).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

February 15, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

February 5, 2019

Last Update Submit

February 12, 2019

Conditions

Borderline Personality Disorder

Keywords

Borderline Personality DisorderPersonality Disorders

Outcome Measures

Primary Outcomes (3)

  • Borderline Symptoms List (BSL)

    BSL is a 23 item scale that evaluates the general symptoms and 11 items with behavioural evaluation of BPD.

    6 weeks

  • Global Clinical Impression of BPD (GCI-BPD)

    CGI-BPD is a 10 item evaluation that rates the severity of BPD distributed in 9 neuropsychological domains with a final global score.

    6 weeks

  • Borderline Evaluation of Severity Over Time (BEST)

    BEST is a 15 item scale that evaluates the severity in this pathology according to 3 areas: thoughts, emotions and typical behaviours.

    6 weeks

Secondary Outcomes (3)

  • Hamilton Depression Rating Scale (HDRS)

    6 weeks

  • Hamilton Anxiety Rating Scale (HARS)

    6 weeks

  • Barratt Impulsivity Scale (BIS-11)

    6 weeks

Study Arms (2)

5 Hz Stimulation

ACTIVE COMPARATOR

This group will receive 5Hz (Hertz) Dorsomedial Prefrontal Cortex repetitive Transcranial Magnetic Stimulation with 1500 pulses per session, once per weekday, with a final result of 15 sessions in this modality.

Device: Repetitive Transcranial Magnetic Stimulation

Placebo Stimulation

PLACEBO COMPARATOR

This group will receive the Sham modality simulating 1500 pulses of 5Hz Transcranial Magnetic Stimulation for 15 sessions, one per weekday.

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

Subjects will receive both active and placebo rTMS, in a crossover modality.

Also known as: Transcranial Magnetic Stimulation
5 Hz StimulationPlacebo Stimulation

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old.
  • Meet DSM 5 (Diagnostic and Statistical Manual, 5th edition) diagnostic criteria for Borderline Personality Disorder.
  • Score of \>7 in the Diagnostic Interview for Borderline (Revised version, DIB-R)
  • All patients must have follow-up psychotherapy of at least one month.
  • No changes on pharmacological treatment within the last month.
  • Patients must provide their oral and written informed consent.

You may not qualify if:

  • Subjects with history of traumatic brain injury with loss of consciousness.
  • Subjects with intracranial metallic objects or metal plates in the skull.
  • Subjects diagnosed with uncontrolled chronic (for example: hypertension, diabetes) or neurological diseases.
  • Comorbidity with other mental illness. (Except Depressive symptoms and Anxiety Disorders).
  • Presence of psychotic symptoms.
  • Alterations in the electroencephalogram (epileptiform activity).
  • Self injury or suicidal attempts in less than 2 weeks (depends on the severity and deepness).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Autonomous University of Queretaro

Querétaro City, Querétaro, 76176, Mexico

RECRUITING

Related Publications (1)

  • Calderon-Moctezuma AR, Reyes-Lopez JV, Rodriguez-Valdes R, Barbosa-Luna M, Ricardo-Garcell J, Espino-Cortes M, Hernandez-Chan N, Garcia-Noguez L, Roque-Roque G, Trejo-Cruz G, Canizares-Gomez S, Hernandez-Montiel H. Improvement in borderline personality disorder symptomatology after repetitive transcranial magnetic stimulation of the dorsomedial prefrontal cortex: preliminary results. Braz J Psychiatry. 2021 Feb 1;43(1):65-69. doi: 10.1590/1516-4446-2019-0591. eCollection 2020.

    PMID: 32876128DERIVED

MeSH Terms

Conditions

Borderline Personality DisorderPersonality Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Julian V Reyes-López, Psychiatrist

    Faculty of Medicine, Autonomous University of Queretaro

    STUDY DIRECTOR

Central Study Contacts

Angel R Calderón-Moctezuma, Physician

CONTACT

+52 9511047213angel_roman_cm@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The aim of this study is to evaluate the clinical effects of 5Hz rTMS over Dorsomedial Prefrontal Cortex on an active versus placebo modality stimulation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 5, 2019

First Posted

February 6, 2019

Study Start

March 5, 2018

Primary Completion

January 30, 2019

Study Completion

August 30, 2019

Last Updated

February 15, 2019

Record last verified: 2019-01

Locations

ME(1)