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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
History of Changes
  Purpose

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 Intervention
Borderline Personality Disorder
 Procedure: repetitive Transcranial Stimulation Magnetic (rTMS)
Procedure: sham rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Borderline Personality Disorder (BPD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Tower of London [ Time Frame: Inclusion, 15th day, 30th day and 3rd month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 13
Study Start Date: January 2010
Study Completion Date: April 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01076933     History of Changes
Other Study ID Numbers: 08 153 02, AOL 2008
Study First Received: January 6, 2010
Last Updated: June 25, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013