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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01076933
Other study ID # 08 153 02
Secondary ID AOL 2008
Status Completed
Phase N/A
First received January 6, 2010
Last updated May 10, 2017
Start date January 2010
Est. completion date April 2012

Study information

Verified date May 2017
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date April 2012
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility 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 Design


Intervention

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 rTMS
sham rTMS

Locations

Country Name City State
France Lionel Cailhol Toulouse University Hospital Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Cailhol L, Roussignol B, Klein R, Bousquet B, Simonetta-Moreau M, Schmitt L, Thalamas C, Tap G, Birmes P. Borderline personality disorder and rTMS: a pilot trial. Psychiatry Res. 2014 Apr 30;216(1):155-7. doi: 10.1016/j.psychres.2014.01.030. Epub 2014 Jan — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Tower of London Inclusion, 15th day, 30th day and 3rd month
Secondary Balloon Analog Risk Task Inclusion, 15th day, 30th day and 3rd month
Secondary Micro-World Test Inclusion, 15th day and 3rd month
Secondary Borderline Personality Disorder Severity Index Pre-inclusion, 30th day and 3rd month
Secondary Symptom Check List - 90 Inclusion, 15th day, 30th day and 3rd month
Secondary Barratt Impulsivity Scale Inclusion and 3rd month
Secondary Global Assessment Scale Inclusion and 3rd month
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