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

May 10, 2017 updated by: University Hospital, Toulouse

Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Borderline Personality Disorder (BPD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • University Hospital Toulouse
      • Toulouse, University Hospital Toulouse, France, 31059
        • Lionel Cailhol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS
rTMS sessions
Procedure: repetitive Transcranial Stimulation Magnetic (rTMS)
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.
Sham Comparator: control
sham rTMS (control)
Procedure: sham rTMS
sham rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tower of London
Time Frame: Inclusion, 15th day, 30th day and 3rd month
Inclusion, 15th day, 30th day and 3rd month

Secondary Outcome Measures

Outcome Measure
Time Frame
Balloon Analog Risk Task
Time Frame: Inclusion, 15th day, 30th day and 3rd month
Inclusion, 15th day, 30th day and 3rd month
Micro-World Test
Time Frame: Inclusion, 15th day and 3rd month
Inclusion, 15th day and 3rd month
Borderline Personality Disorder Severity Index
Time Frame: Pre-inclusion, 30th day and 3rd month
Pre-inclusion, 30th day and 3rd month
Symptom Check List - 90
Time Frame: Inclusion, 15th day, 30th day and 3rd month
Inclusion, 15th day, 30th day and 3rd month
Barratt Impulsivity Scale
Time Frame: Inclusion and 3rd month
Inclusion and 3rd month
Global Assessment Scale
Time Frame: Inclusion and 3rd month
Inclusion and 3rd month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Lionel Cailhol, MD, University Hospital Toulouse - 31059 Toulouse - France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

January 6, 2010

First Submitted That Met QC Criteria

February 25, 2010

First Posted (Estimate)

February 26, 2010

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08 153 02
  • AOL 2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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