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

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ClinicalTrials.gov Identifier: NCT01076933
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Borderline Personality Disorder Procedure: repetitive Transcranial Stimulation Magnetic (rTMS) Procedure: sham rTMS

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Borderline Personality Disorder (BPD)
Study Start Date : January 2010
Primary Completion Date : March 2011
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Tower of London [ Time Frame: Inclusion, 15th day, 30th day and 3rd month ]

Secondary Outcome Measures :
  1. Balloon Analog Risk Task [ Time Frame: Inclusion, 15th day, 30th day and 3rd month ]
  2. Micro-World Test [ Time Frame: Inclusion, 15th day and 3rd month ]
  3. Borderline Personality Disorder Severity Index [ Time Frame: Pre-inclusion, 30th day and 3rd month ]
  4. Symptom Check List - 90 [ Time Frame: Inclusion, 15th day, 30th day and 3rd month ]
  5. Barratt Impulsivity Scale [ Time Frame: Inclusion and 3rd month ]
  6. Global Assessment Scale [ Time Frame: Inclusion and 3rd month ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076933


Locations
France
Lionel Cailhol
Toulouse, University Hospital Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Lionel Cailhol, MD University Hospital Toulouse - 31059 Toulouse - France
More Information

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01076933     History of Changes
Other Study ID Numbers: 08 153 02
AOL 2008
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by University Hospital, Toulouse:
Borderline Personality Disorder
Transcranial Magnetic Stimulation
Neuropsychological Test
Randomised Control Trial

Additional relevant MeSH terms:
Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders