Clinical trial NCT02273674: TMS in Borderline Personality Disorder Patients
Official title: Repetitive Transcranial Magnetic Stimulation in Borderline Personality Disorder Patients. Effects in Clinical Measurements, Inhibition, Cognitive Flexibility, and Social Cognition Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Borderline Personality Disorder
Transcranial Magnetic Stimulation, Repetitive
Lead sponsor: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Sponsor class: OTHER
Collaborators: name: Universidad Nacional Autonoma de Mexico
First posted: 2014-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in BORDERLINE EVALUATION OF SEVERITY OVER TIME (BEST)
timeFrame: Inclusion, after 15 days of treatment and at 8 weeks follow up
Secondary outcomes:
measure: Change from Baseline in Barratt impulsiveness scale
timeFrame: IInclusion, after 15 days of treatment and at 8 weeks follow up
measure: Change from Baseline in Hamilton Depression rating scale
timeFrame: Inclusion, after 15 days of treatment and at 8 weeks follow up
measure: Change from Baseline in Wisconsin card sorting test (WCST)
timeFrame: Inclusion, after 15 days of treatment and at 8 weeks follow up
measure: Change from Baseline in Stop Signal Task (SST)
timeFrame: Inclusion, after 15 days of treatment and at 8 weeks follow up
measure: Change from Baseline in Reading the Mind in the Eyes Test
timeFrame: Inclusion, after 15 days of treatment and at 8 weeks follow up
Other outcomes:
Locations:
city: Mexico Distrito Federal
country: Mexico
facility: Instituto Nacional de Psiquiatria Ramon de la Fuente
Study officials:
affiliation: Instituto Nacional de Psiquiatria
name: Julian V Reyes, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.