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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01076933
First received: January 6, 2010
Last updated: June 25, 2012
Last verified: June 2012

January 6, 2010
June 25, 2012
January 2010
March 2011   (final data collection date for primary outcome measure)
Tower of London [ Time Frame: Inclusion, 15th day, 30th day and 3rd month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01076933 on ClinicalTrials.gov Archive Site
  • Balloon Analog Risk Task [ Time Frame: Inclusion, 15th day, 30th day and 3rd month ] [ Designated as safety issue: No ]
  • Micro-World Test [ Time Frame: Inclusion, 15th day and 3rd month ] [ Designated as safety issue: No ]
  • Borderline Personality Disorder Severity Index [ Time Frame: Pre-inclusion, 30th day and 3rd month ] [ Designated as safety issue: No ]
  • Symptom Check List - 90 [ Time Frame: Inclusion, 15th day, 30th day and 3rd month ] [ Designated as safety issue: No ]
  • Barratt Impulsivity Scale [ Time Frame: Inclusion and 3rd month ] [ Designated as safety issue: No ]
  • Global Assessment Scale [ Time Frame: Inclusion and 3rd month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Transcranial Magnetic Stimulation for Borderline Personality Disorder
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Borderline Personality Disorder
  • 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.
  • Procedure: sham rTMS
    sham rTMS
  • Experimental: rTMS
    rTMS sessions
    Intervention: Procedure: repetitive Transcranial Stimulation Magnetic (rTMS)
  • Sham Comparator: control
    sham rTMS (control)
    Intervention: Procedure: sham rTMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
April 2012
March 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01076933
08 153 02, AOL 2008
No
University Hospital, Toulouse
University Hospital, Toulouse
Not Provided
Principal Investigator: Lionel Cailhol, MD University Hospital Toulouse - 31059 Toulouse - France
University Hospital, Toulouse
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP