NCT01076933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

January 6, 2010

Last Update Submit

May 10, 2017

Conditions

Borderline Personality Disorder

Keywords

Borderline Personality DisorderTranscranial Magnetic StimulationNeuropsychological TestRandomised Control Trial

Outcome Measures

Primary Outcomes (1)

  • Tower of London

    Inclusion, 15th day, 30th day and 3rd month

Secondary Outcomes (6)

  • Balloon Analog Risk Task

    Inclusion, 15th day, 30th day and 3rd month

  • Micro-World Test

    Inclusion, 15th day and 3rd month

  • Borderline Personality Disorder Severity Index

    Pre-inclusion, 30th day and 3rd month

  • Symptom Check List - 90

    Inclusion, 15th day, 30th day and 3rd month

  • Barratt Impulsivity Scale

    Inclusion and 3rd month

  • +1 more secondary outcomes

Study Arms (2)

rTMS

EXPERIMENTAL

rTMS sessions

Procedure: repetitive Transcranial Stimulation Magnetic (rTMS)

control

SHAM COMPARATOR

sham rTMS (control)

Procedure: sham rTMS

Interventions

repetitive Transcranial Stimulation Magnetic (rTMS)PROCEDURE

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.

rTMS
sham rTMSPROCEDURE

sham rTMS

control

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 45 years old
  • Borderline Personality Disorder (Diagnostic Interview for Borderline Personality Disorder \> 8)
  • psychiatric follow-up
  • righthander
  • informed consent
  • affiliated to medical insurance

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lionel Cailhol

Toulouse, University Hospital Toulouse, 31059, France

Location

Related 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 30.

    PMID: 24503285RESULT

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Lionel Cailhol, MD

    University Hospital Toulouse - 31059 Toulouse - France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2010

First Posted

February 26, 2010

Study Start

January 1, 2010

Primary Completion

March 1, 2011

Study Completion

April 1, 2012

Last Updated

May 11, 2017

Record last verified: 2017-05

Locations

FR(1)