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Completed

NCT Number: NCT02273674

TMS in Borderline Personality Disorder Patients

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.

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Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Psiquiatria Ramon de la Fuente

Mexico City, 14370, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Left rTMS 5 Hz

Device

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

Right r TMS 1 Hz

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Other

Collaborators

  • Universidad Nacional Autonoma de Mexico

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2014
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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