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Transcranial Magnetic Stimulation for Borderline Personality Disorder (SiMaT-B)

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
repetitive Transcranial Stimulation Magnetic (rTMS)
sham rTMS
Sponsored by
University Hospital, Toulouse
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, Neuropsychological Test, Randomised Control Trial

Eligibility Criteria

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

Inclusion Criteria:

  • 20 to 45 years old
  • Borderline Personality Disorder (Diagnostic Interview for Borderline Personality Disorder > 8)
  • psychiatric follow-up
  • righthander
  • informed consent
  • affiliated to medical insurance

Exclusion Criteria:

  • bipolar disorder
  • substance use disorder
  • Major Depressive Disorder or Stress Post Traumatic Disorder
  • history of epilepsy
  • neurosurgery
  • cardiac pacemaker
  • lefthander
  • involuntary admission
  • participation in an other research
  • legal guardianship
  • poor mastery of french.

Sites / Locations

  • Lionel Cailhol

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

rTMS

control

Arm Description

rTMS sessions

sham rTMS (control)

Outcomes

Primary Outcome Measures

Tower of London

Secondary Outcome Measures

Balloon Analog Risk Task
Micro-World Test
Borderline Personality Disorder Severity Index
Symptom Check List - 90
Barratt Impulsivity Scale
Global Assessment Scale

Full Information

First Posted
January 6, 2010
Last Updated
May 10, 2017
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT01076933
Brief Title
Transcranial Magnetic Stimulation for Borderline Personality Disorder
Acronym
SiMaT-B
Official Title
Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Borderline Personality Disorder (BPD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary purpose : to assess the effect on neuropsychological tasks related to planning of 10 daily sessions of right dorsolateral prefrontal cortex with High-frequency repetitive transcranial magnetic stimulation (rTMS) on borderline personality disorder (BPD) patients. Hypothesis : BPD patients receiving 10 sessions of rTMS will have greater improvement in the average number of move to achieve tasks of the Tower of London, than those receiving sham rTMS.

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, Neuropsychological Test, Randomised Control Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS
Arm Type
Experimental
Arm Description
rTMS sessions
Arm Title
control
Arm Type
Sham Comparator
Arm Description
sham rTMS (control)
Intervention Type
Procedure
Intervention Name(s)
repetitive Transcranial Stimulation Magnetic (rTMS)
Intervention Description
The motor threshold was determined in each subject once, before treatment. This was defined as the lowest stimulation intensity capable of inducing a visible movement at least five times out of 10 stimulations. The position of the right dorsolateral prefrontal cortex was defined as 5 cm anterior (in a parasagittal line) to the motor cortex. The stimulus intensity was 80% of the patient's motor threshold intensity. Treatments were given for 20 minutes per day over 10 working days.
Intervention Type
Procedure
Intervention Name(s)
sham rTMS
Intervention Description
sham rTMS
Primary Outcome Measure Information:
Title
Tower of London
Time Frame
Inclusion, 15th day, 30th day and 3rd month
Secondary Outcome Measure Information:
Title
Balloon Analog Risk Task
Time Frame
Inclusion, 15th day, 30th day and 3rd month
Title
Micro-World Test
Time Frame
Inclusion, 15th day and 3rd month
Title
Borderline Personality Disorder Severity Index
Time Frame
Pre-inclusion, 30th day and 3rd month
Title
Symptom Check List - 90
Time Frame
Inclusion, 15th day, 30th day and 3rd month
Title
Barratt Impulsivity Scale
Time Frame
Inclusion and 3rd month
Title
Global Assessment Scale
Time Frame
Inclusion and 3rd month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 20 to 45 years old Borderline Personality Disorder (Diagnostic Interview for Borderline Personality Disorder > 8) psychiatric follow-up righthander informed consent affiliated to medical insurance Exclusion Criteria: bipolar disorder substance use disorder Major Depressive Disorder or Stress Post Traumatic Disorder history of epilepsy neurosurgery cardiac pacemaker lefthander involuntary admission participation in an other research legal guardianship poor mastery of french.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lionel Cailhol, MD
Organizational Affiliation
University Hospital Toulouse - 31059 Toulouse - France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lionel Cailhol
City
Toulouse
State/Province
University Hospital Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24503285
Citation
Cailhol L, Roussignol B, Klein R, Bousquet B, Simonetta-Moreau M, Schmitt L, Thalamas C, Tap G, Birmes P. Borderline personality disorder and rTMS: a pilot trial. Psychiatry Res. 2014 Apr 30;216(1):155-7. doi: 10.1016/j.psychres.2014.01.030. Epub 2014 Jan 30.
Results Reference
result

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Transcranial Magnetic Stimulation for Borderline Personality Disorder

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