Borderline Personality DisorderNCT01602497
Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder
A study testing rTMS in people with Borderline Personality Disorder, run by Tehran University of Medical Sciences.
Trial summary
This study is going to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on Borderline Personality Disorder patients symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed borderline personality disorder according to DSM IV.
Who cannot join
- Epilepsy
- Any metal device
- Psychotic disorders
- Bipolar mood disorder type 1
About this study
Official title: A Sham-controlled Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder Patients
This study is going to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on Borderline Personality Disorder patients symptoms.
Read the detailed description
There is a great body of literature about the positive effects of rTMS therapy on various psychiatric disorders. In this study we are going to evaluate the effects of high-frequency rTMS over the left dorsolateral prefrontal cortex (DLPFC)region in borderline personality disorder (BPD) patients. patients will be assessed by subjective measures for BPD.
- Conditions
- Borderline Personality Disorder
- Being tested
- rTMS, sham rTMS
- Keywords
- Borderline personality disorder, repetitive transcranial magnetic stimulation
- 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.
rTMSDevice
Also called repetitive transcranial magnetic stimulation
Patients undergone 10 session of high-frequency rTMS therapy over their left DLPFC
sham rTMSDevice
Also called sham repetitive transcranial magnetic stimulation
Patients will undergo ten session of sham rTMS.
| Study group | Role | What they receive |
|---|---|---|
| rTMS intervention group | Active comparator | The rTMS intervention group undergo ten session of real TMS therapy. Receives: Device: rTMS |
| Sham group | Placebo comparator | Patients will undergo ten session of sham rTMS. Receives: Device: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' reports
changes in subjective measures from baseline to tenth day of treatment
Measured: Change from baseline to two weeks
Secondary outcomes (2)
patient's report
change in subjective measures from baseline to 1 month after treatment
Measured: Change from baseline to 1 month
Patient's report
change in subjective measures form baseline to 3 month after treatment
Measured: Change from baseline to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Arbabi, M.D., Study director, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602497
- Sponsor's protocol ID
- 90-01-30-13200
- Status last verified
- May 2012
- First submitted
- 16 May 2012
- Last updated
- 21 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sham-controlled Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder Patients
- ClinicalTrials.gov ID
- NCT01602497
- Acronym / sponsor ID
- 90-01-30-13200
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline personality disorder, repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 21 May 2012 (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.
This study is going to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on Borderline Personality Disorder patients symptoms.
Detailed description
There is a great body of literature about the positive effects of rTMS therapy on various psychiatric disorders. In this study we are going to evaluate the effects of high-frequency rTMS over the left dorsolateral prefrontal cortex (DLPFC)region in borderline personality disorder (BPD) patients. patients will be assessed by subjective measures for BPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS intervention group | Active comparator | Device: rTMSThe rTMS intervention group undergo ten session of real TMS therapy. |
| Sham group | Placebo comparator | Device: sham rTMSPatients will undergo ten session of sham rTMS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically diagnosed borderline personality disorder according to DSM IV.
Key exclusion criteria (4 listed)
- Epilepsy
- Any metal device
- Psychotic disorders
- Bipolar mood disorder type 1
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 |
|---|---|---|
| rTMSAlso: repetitive transcranial magnetic stimulationPatients undergone 10 session of high-frequency rTMS therapy over their left DLPFC | Device | rTMS intervention group |
| sham rTMSAlso: sham repetitive transcranial magnetic stimulationPatients will undergo ten session of sham rTMS. | Device | Sham group |
Primary outcome
Patients' reports
Time frame: Change from baseline to two weeks
changes in subjective measures from baseline to tenth day of treatment
2 secondary outcomes
patient's report
Time frame: Change from baseline to 1 month
Patient's report
Time frame: Change from baseline to 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.
Related trials for Borderline Personality Disorder
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Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
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Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
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MDMA in Borderline Personality Disorder
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Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
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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.
Mohammad Arbabi, M.D. study director
Tehran University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Borderline Personality Disorder, run by Tehran University of Medical Sciences.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Patients' reports (time frame: Change from baseline to two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2012.