Borderline Personality DisorderSiMaT-BNCT01076933
Transcranial Magnetic Stimulation for Borderline Personality Disorder
A study testing repetitive Transcranial Stimulation Magnetic (rTMS) in people with Borderline Personality Disorder, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- repetitive Transcranial Stimulation Magnetic (rTMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- bipolar disorder
- substance use disorder
- Major Depressive Disorder or Stress Post Traumatic Disorder
- history of epilepsy
- neurosurgery
- cardiac pacemaker
Show all 11Show fewer
- lefthander
- involuntary admission
- participation in an other research
- legal guardianship
- poor mastery of french.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- repetitive Transcranial Stimulation Magnetic (rTMS), sham rTMS
- Keywords
- Borderline Personality Disorder, Transcranial Magnetic Stimulation, Neuropsychological Test, Randomised Control Trial
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Stimulation Magnetic (rTMS)Procedure or surgery
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 rTMSProcedure or surgery
sham rTMS
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Experimental | rTMS sessions Receives: Procedure: repetitive Transcranial Stimulation Magnetic (rTMS) |
| control | Sham comparator | sham rTMS (control) Receives: Procedure: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tower of London
Measured: Inclusion, 15th day, 30th day and 3rd month
Secondary outcomes (6)
Balloon Analog Risk Task
Measured: Inclusion, 15th day, 30th day and 3rd month
Micro-World Test
Measured: Inclusion, 15th day and 3rd month
Borderline Personality Disorder Severity Index
Measured: Pre-inclusion, 30th day and 3rd month
Symptom Check List - 90
Measured: Inclusion, 15th day, 30th day and 3rd month
Barratt Impulsivity Scale
Measured: Inclusion and 3rd month
Global Assessment Scale
Measured: Inclusion and 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lionel Cailhol, MD, Principal investigator, University Hospital Toulouse - 31059 Toulouse - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076933
- Sponsor's protocol ID
- 08 153 02
- Other IDs
- AOL 2008
- Acronym
- SiMaT-B
- Status last verified
- May 2017
- First submitted
- 6 Jan 2010
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24503285
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Borderline Personality Disorder (BPD)
- ClinicalTrials.gov ID
- NCT01076933
- Acronym / sponsor ID
- SiMaT-B / 08 153 02
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline Personality Disorder, Transcranial Magnetic Stimulation, Neuropsychological Test, Randomised Control Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS | Experimental | Procedure: repetitive Transcranial Stimulation Magnetic (rTMS)rTMS sessions |
| control | Sham comparator | Procedure: sham rTMSsham rTMS (control) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 20 to 45 years old
- Borderline Personality Disorder (Diagnostic Interview for Borderline Personality Disorder > 8)
- psychiatric follow-up
- righthander
- informed consent
Key exclusion criteria (11 listed)
- bipolar disorder
- substance use disorder
- Major Depressive Disorder or Stress Post Traumatic Disorder
- history of epilepsy
- neurosurgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | rTMS |
| sham rTMSsham rTMS | Procedure or surgery | control |
Primary outcome
Tower of London
Time frame: Inclusion, 15th day, 30th day and 3rd month
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Results publication: PubMed 24503285Cailhol 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lionel Cailhol, MD principal investigator
University Hospital Toulouse - 31059 Toulouse - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Stimulation Magnetic (rTMS) in people with Borderline Personality Disorder, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tower of London (time frame: Inclusion, 15th day, 30th day and 3rd month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01076933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.