TMS in Borderline Personality Disorder Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Device: Left rTMS 5 Hz
* Device: Right r TMS 1 Hz


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left rTMS 5 Hz<br>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<br>* 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<br>|
| Experimental: Right r TMS 1 Hz<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Barratt impulsiveness scale | 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 | 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) | 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Borderline Personality Disorder, Transcranial Magnetic Stimulation, Repetitive