NCT02273674

Brief Summary

The purpose of this study is to determine the potential effects of repetitive transcranial magnetic stimulation in the improvement of neuropsychological deficits and symptomatology in borderline personality disorder patients. Specially in cognitive flexibility, inhibition control and social cognition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

October 15, 2014

Last Update Submit

February 22, 2016

Conditions

Keywords

Borderline Personality DisorderTranscranial Magnetic Stimulation, Repetitive

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in BORDERLINE EVALUATION OF SEVERITY OVER TIME (BEST)

    The Borderline Evaluation of Severity Over Time (BEST) was developed to rate the thoughts, emotions, and behaviors typical of borderline personality disorder.

    Inclusion, after 15 days of treatment and at 8 weeks follow up

Secondary Outcomes (5)

  • Change from Baseline in Barratt impulsiveness scale

    IInclusion, after 15 days of treatment and at 8 weeks follow up

  • Change from Baseline in Hamilton Depression rating scale

    Inclusion, after 15 days of treatment and at 8 weeks follow up

  • Change from Baseline in Wisconsin card sorting test (WCST)

    Inclusion, after 15 days of treatment and at 8 weeks follow up

  • Change from Baseline in Stop Signal Task (SST)

    Inclusion, after 15 days of treatment and at 8 weeks follow up

  • Change from Baseline in Reading the Mind in the Eyes Test

    Inclusion, after 15 days of treatment and at 8 weeks follow up

Study Arms (2)

Left rTMS 5 Hz

EXPERIMENTAL

This group receive transcranial magnetic stimulation at 5 Hz of frequency over left dorsolateral prefrontal cortex. Once a day on monday to friday. Until receive 15 sessions. After this the subjects, will be received 8 more sessions of TMS, one session at week for next eight weeks

Device: Left rTMS 5 Hz

Right r TMS 1 Hz

EXPERIMENTAL

This group receive transcranial magnetic stimulation at 1 Hz of frequency over right dorsolateral prefrontal cortex. Once a day on monday to friday. Until receive 15 sessions. After this the subjects, will be received 8 more sessions of TMS, one session at week for next eight weeks

Device: Right r TMS 1 Hz

Interventions

The subjects will receive transcranial magnetic stimulation (5 Hz of frequency over left dorsolateral prefrontal cortex . Once a day on monday to friday. Until receive 15 sessions. After this the subjects, will be received 8 more sessions of TMS, one session at week for next eight weeks

Left rTMS 5 Hz

The subjects will receive transcranial magnetic stimulation (1 Hz of frequency over right dorsolateral prefrontal cortex . Once a day on monday to friday. Until receive 15 sessions. After this the subjects, will be received 8 more sessions of TMS, one session at week for next eight weeks

Right r TMS 1 Hz

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of borderline personality disorder according to diagnostic and statistical manual of mental disorders IV text revision
  • Treatment with selective inhibitors of serotonin reuptake
  • Mass corporal index more than 19

You may not qualify if:

  • Suicide risk or suicide attempt recent or actual
  • History of epilepsy or seizures
  • History of cranial trauma with loss awareness
  • Intracranial or intraocular ferromagnetic devices, including skull prosthesis.
  • Pregnant womens.
  • Neurosurgery, cardiac pacemaker, lefthander
  • Patients with psychotic symptoms, bipolar disorder or substance addiction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Psiquiatria Ramon de la Fuente

Mexico City, Mexico City, 14370, Mexico

Location

Related Publications (2)

  • Arbabi M, Hafizi S, Ansari S, Oghabian MA, Hasani N. High frequency TMS for the management of Borderline Personality Disorder: a case report. Asian J Psychiatr. 2013 Dec;6(6):614-7. doi: 10.1016/j.ajp.2013.05.006. Epub 2013 Jun 14.

    PMID: 24309885BACKGROUND
  • Reyes-Lopez J, Ricardo-Garcell J, Armas-Castaneda G, Garcia-Anaya M, Arango-De Montis I, Gonzalez-Olvera JJ, Pellicer F. Clinical improvement in patients with borderline personality disorder after treatment with repetitive transcranial magnetic stimulation: preliminary results. Braz J Psychiatry. 2018 Jan-Mar;40(1):97-104. doi: 10.1590/1516-4446-2016-2112. Epub 2017 Jun 12.

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Officials

  • Julian V Reyes, M.D.

    Instituto Nacional de Psiquiatria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor Psychiatry

Study Record Dates

First Submitted

October 15, 2014

First Posted

October 24, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations