- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01076933
Transcranial Magnetic Stimulation for Borderline Personality Disorder (SiMaT-B)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
University Hospital Toulouse
-
Toulouse, University Hospital Toulouse, France, 31059
- Lionel Cailhol
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: rTMS
rTMS sessions
|
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)
|
sham rTMS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tower of London
Time Frame: Inclusion, 15th day, 30th day and 3rd month
|
Inclusion, 15th day, 30th day and 3rd month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Balloon Analog Risk Task
Time Frame: Inclusion, 15th day, 30th day and 3rd month
|
Inclusion, 15th day, 30th day and 3rd month
|
Micro-World Test
Time Frame: Inclusion, 15th day and 3rd month
|
Inclusion, 15th day and 3rd month
|
Borderline Personality Disorder Severity Index
Time Frame: Pre-inclusion, 30th day and 3rd month
|
Pre-inclusion, 30th day and 3rd month
|
Symptom Check List - 90
Time Frame: Inclusion, 15th day, 30th day and 3rd month
|
Inclusion, 15th day, 30th day and 3rd month
|
Barratt Impulsivity Scale
Time Frame: Inclusion and 3rd month
|
Inclusion and 3rd month
|
Global Assessment Scale
Time Frame: Inclusion and 3rd month
|
Inclusion and 3rd month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lionel Cailhol, MD, University Hospital Toulouse - 31059 Toulouse - France
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08 153 02
- AOL 2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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