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

Tracking Information

First Received Date ^ICMJE

January 6, 2010

Last Updated Date

June 25, 2012

Start Date ^ICMJE

January 2010

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01076933 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Transcranial Magnetic Stimulation for Borderline Personality Disorder

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Borderline Personality Disorder

Intervention ^ICMJE

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

Study Arm (s)

Experimental: rTMS
rTMS sessions

Intervention: Procedure: repetitive Transcranial Stimulation Magnetic (rTMS)
Sham Comparator: control
sham rTMS (control)

Intervention: Procedure: sham rTMS

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2012

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01076933

Other Study ID Numbers ^ICMJE

08 153 02, AOL 2008

Has Data Monitoring Committee

Responsible Party

University Hospital, Toulouse

Study Sponsor ^ICMJE

University Hospital, Toulouse

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lionel Cailhol, MD

University Hospital Toulouse - 31059 Toulouse - France

Information Provided By

University Hospital, Toulouse

Verification Date

June 2012

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

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