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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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
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
Instituto Nacional de Psiquiatria Ramon de la Fuente
Mexico City, Mexico City, Mexico
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.
Time frame: Inclusion, after 15 days of treatment and at 8 weeks follow up
Change from Baseline in Barratt impulsiveness scale
The Barratt Impulsiveness Scale is a questionnaire designed to assess the personality/behavioral construct of impulsiveness.
Time frame: IInclusion, after 15 days of treatment and at 8 weeks follow up
Change from Baseline in Hamilton Depression rating scale
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
Time frame: Inclusion, after 15 days of treatment and at 8 weeks follow up
Change from Baseline in Wisconsin card sorting test (WCST)
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.
Time frame: Inclusion, after 15 days of treatment and at 8 weeks follow up
Change from Baseline in Stop Signal Task (SST)
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.
Time frame: Inclusion, after 15 days of treatment and at 8 weeks follow up
Change from Baseline in Reading the Mind in the Eyes Test
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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.
Time frame: Inclusion, after 15 days of treatment and at 8 weeks follow up