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Status unknownNCT03832777TMS&BPDUpdated Feb 15, 2019

Transcranial Magnetic Stimulation on Dorsomedial Prefrontal Cortex in Borderline Personality Disorder

An interventional study of Repetitive Transcranial Magnetic Stimulation in Borderline Personality Disorder, sponsored by Universidad Autonoma de Queretaro. Status unknown at 1 site in Mexico. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Universidad Autonoma de Queretaro · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Mar 2018, registered Feb 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
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Study summary

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

Read the detailed description

Borderline Personality Disorder (BPD) is a mental illness with a high worldwide prevalence and economic costs, and is characterized with impulsiveness, both interpersonal relationships and emotional disturbance. Symptoms are related to hypofunction of frontal areas like Dorsomedial Prefrontal Cortex (DMPFC). Psychotherapy is the base treatment in this disease, but economic costs and long-time therapy have made difficult the attachment. Repetitive Transcranial Magnetic Stimulation(rTMS), authorized by Food and Drug Administration (FDA) on Major Depressive Disorder (MDD) treatment has proven good results in previous works in BPD clinical characteristics on both dorsolateral prefrontal cortex (DLPFC) and enhancement in depressive symptoms stimulating DMPFC in high frequency. However, there are no current research that have addressed the use of low-frequency on this anatomical area.

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Conditions studied

  • Borderline Personality Disorder

Keywords

  • Borderline Personality Disorder
  • Personality Disorders
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In context

Borderline Personality Disorder

277 studies on the registry are indexed under Borderline Personality Disorder; 68 are open to participants now.

This study's planned enrollment of 20 is below the median of 70 across 222 interventional studies indexed under Borderline Personality Disorder.

Browse Borderline Personality Disorder studies →

Lead sponsor

Universidad Autonoma de Queretaro is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18-45 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    5 Hz Stimulation

    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 comparator
    Placebo Stimulation

    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

  • DeviceRepetitive Transcranial Magnetic Stimulation

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

    Also known as: Transcranial Magnetic Stimulation

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What researchers measure

Primary outcomes

  1. Borderline Symptoms List (BSL)

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

    Time frame: 6 weeks

  2. 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.

    Time frame: 6 weeks

  3. 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.

    Time frame: 6 weeks

Secondary outcomes

  1. Hamilton Depression Rating Scale (HDRS)

    HDRS is a 21 item scale that evaluates the severity of depressive symptoms in patients.

    Time frame: 6 weeks

  2. Hamilton Anxiety Rating Scale (HARS)

    HARS is a 14 items rating scale that evaluates the severity of anxiety symptoms in patients.

    Time frame: 6 weeks

  3. Barratt Impulsivity Scale (BIS-11)

    The Barratt Impulsiveness Scale is a questionnaire designed to assess the personality / behavioral construct of impulsiveness; composed of 30 items describing common impulsive or non-impulsive (for reversed scored items) behaviors and preferences .

    Time frame: 6 weeks

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Study locations

1 of 1 sites recruiting
  • Autonomous University of Queretaro
    Querétaro City, Querétaro 76176, Mexico
    Recruiting
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References and documents

Publications

  • 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. PubMed 32876128 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03832777
Lead sponsor
Universidad Autonoma de Queretaro
Responsible party
Dr. Julian Reyes López (Professor, Universidad Autonoma de Queretaro) — Principal investigator
First posted
Feb 6, 2019
Start date
Mar 5, 2018
Primary completion
Jan 30, 2019
Completion
Aug 30, 2019 (estimated)
Last update
Feb 15, 2019

Study contacts

Angel R Calderón-Moctezuma, Physician
Contact
angel_roman_cm@hotmail.com
+52 9511047213
Julian V Reyes-López, Psychiatrist
study director · Faculty of Medicine, Autonomous University of Queretaro

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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