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TMS in Borderline Personality Disorder Patients

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Left rTMS 5 Hz
Right r TMS 1 Hz
Sponsored by
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline Personality Disorder, Transcranial Magnetic Stimulation, Repetitive

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto Nacional de Psiquiatria Ramon de la Fuente

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Left rTMS 5 Hz

Right r TMS 1 Hz

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from Baseline in Barratt impulsiveness scale
The Barratt Impulsiveness Scale is a questionnaire designed to assess the personality/behavioral construct of impulsiveness.
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
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.
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.
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.

Full Information

First Posted
October 15, 2014
Last Updated
February 22, 2016
Sponsor
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Collaborators
Universidad Nacional Autonoma de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT02273674
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Collaborators
Universidad Nacional Autonoma de Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Borderline Personality Disorder, Transcranial Magnetic Stimulation, Repetitive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Left rTMS 5 Hz
Arm Type
Experimental
Arm Description
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
Arm Title
Right r TMS 1 Hz
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Left rTMS 5 Hz
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Right r TMS 1 Hz
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline in BORDERLINE EVALUATION OF SEVERITY OVER TIME (BEST)
Description
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
Secondary Outcome Measure Information:
Title
Change from Baseline in Barratt impulsiveness scale
Description
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
Title
Change from Baseline in Hamilton Depression rating scale
Description
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
Title
Change from Baseline in Wisconsin card sorting test (WCST)
Description
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
Title
Change from Baseline in Stop Signal Task (SST)
Description
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
Title
Change from Baseline in Reading the Mind in the Eyes Test
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian V Reyes, M.D.
Organizational Affiliation
Instituto Nacional de Psiquiatria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Psiquiatria Ramon de la Fuente
City
Mexico Distrito Federal
ZIP/Postal Code
14370
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
24309885
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.
Results Reference
background
PubMed Identifier
28614492
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.
Results Reference
derived

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TMS in Borderline Personality Disorder Patients

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