TMS in Borderline Personality Disorder Patients

February 22, 2016 updated by: Julian Reyes Lopez, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Repetitive Transcranial Magnetic Stimulation in Borderline Personality Disorder Patients. Effects in Clinical Measurements, Inhibition, Cognitive Flexibility, and Social Cognition Process

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, parallel group clinical trial to evaluate the efficacy of two protocols of repetitive Transcranial Magnetic Stimulation (rTMS), the application will be over dorsolateral prefrontal cortex (DLPFC) right and left, in patients with borderline personality disorder. 40 ambulatory patients with a borderline personality disorder diagnosis from the National Institute of Psychiatry in México will be included. All Patients will be randomly assigned and will complete a total of 23 sessions rTMS, in any of two groups:

5 Hz Group.- This group will receive rTMS sessions, 5 per week during three weeks (acute treatment phase), and after that, one session a week for the next eight weeks (follow up). The rTMS will be applied over the left DLPFC at 5 Hz, 1500 pulses per session in 100% of Motor threshold

1 Hz Group.- This group will receive rTMS sessions, 5 per week during three weeks (acute treatment phase), and after that, one session a week for the next eight weeks (follow up).

The rTMS will be applied over the right DLPFC at 1 Hz, 900 pulses per session in 100% of Motor threshold All sessions will be applied with a "Dantec" transcranial magnetic stimulator. The affective, borderline and anxiety symptoms will be evaluated at baseline, and every 5 TMS sessions during the acute treatment phase, and once at the end of the 8-weeks follow up. In same form for neuropsychological evaluations .

Categorical variables will be described by percentages and frequencies. Continuous variables will be described by means and standard deviations. Treatment groups will be compared using Student's T test. Cognitive, anxiety, borderline and affective symptom scale scores between treatment groups will be compared using repeated measures ANOVA

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico Distrito Federal, Mexico, 14370
        • Instituto Nacional de Psiquiatria Ramon de la Fuente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Left rTMS 5 Hz
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
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
Experimental: Right r TMS 1 Hz
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in BORDERLINE EVALUATION OF SEVERITY OVER TIME (BEST)
Time Frame: Inclusion, after 15 days of treatment and at 8 weeks follow up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Barratt impulsiveness scale
Time Frame: IInclusion, after 15 days of treatment and at 8 weeks follow up
The Barratt Impulsiveness Scale is a questionnaire designed to assess the personality/behavioral construct of impulsiveness.
IInclusion, after 15 days of treatment and at 8 weeks follow up
Change from Baseline in Hamilton Depression rating scale
Time Frame: Inclusion, after 15 days of treatment and at 8 weeks follow up
The Hamilton depression rating scale is a is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery
Inclusion, after 15 days of treatment and at 8 weeks follow up
Change from Baseline in Wisconsin card sorting test (WCST)
Time Frame: Inclusion, after 15 days of treatment and at 8 weeks follow up
WCST is used primarily to assess perseveration and abstract thinking, the WCST is also considered a measure of executive function because of its reported sensitivity to frontal lobe dysfunction.
Inclusion, after 15 days of treatment and at 8 weeks follow up
Change from Baseline in Stop Signal Task (SST)
Time Frame: Inclusion, after 15 days of treatment and at 8 weeks follow up
SST measuring response inhibition (impulse control). The subject must respond to an arrow stimulus, by touching either of two choices depending on the direction in which the arrow points. If an audio tone is present, the subject must inhibit that response.
Inclusion, after 15 days of treatment and at 8 weeks follow up
Change from Baseline in Reading the Mind in the Eyes Test
Time Frame: Inclusion, after 15 days of treatment and at 8 weeks follow up
The 'Reading the Mind in the Eyes' (Eyes) test is an advanced test of theory of mind. It is widely used to assess individual differences in social cognition and emotion recognition across different groups and cultures.
Inclusion, after 15 days of treatment and at 8 weeks follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Collaborators

Universidad Nacional Autonoma de Mexico

Investigators

  • Principal Investigator: Julian V Reyes, M.D., Instituto Nacional de Psiquiatría

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

October 21, 2014

First Posted (Estimate)

October 24, 2014

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC-14-1006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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