Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Borderline Personality Disorder (BPD)

Resource links provided by NLM:


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 ]

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

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   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on April 25, 2017