TMS in Borderline Personality Disorder Patients

Borderline Personality Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273674
• Other study ID #: SC-14-1006
• Status: Completed
• Phase: N/A
• First received: October 15, 2014
• Last updated: February 22, 2016
• Start date: January 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de SaludMexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

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
• 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

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Psiquiatria Ramon de la Fuente	Mexico Distrito Federal

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente	Universidad Nacional Autonoma de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No