Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder
This study is enrolling participants by invitation only.
Sponsor:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01602497
First received: May 16, 2012
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
This study is going to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on Borderline Personality Disorder patients symptoms.
| Condition | Intervention |
|---|---|
|
Borderline Personality Disorder |
Device: rTMS Device: sham rTMS |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Sham-controlled Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder Patients |
Resource links provided by NLM:
Further study details as provided by Tehran University of Medical Sciences:
Primary Outcome Measures:
- Patients' reports [ Time Frame: Change from baseline to two weeks ] [ Designated as safety issue: Yes ]changes in subjective measures from baseline to tenth day of treatment
Secondary Outcome Measures:
- patient's report [ Time Frame: Change from baseline to 1 month ] [ Designated as safety issue: Yes ]change in subjective measures from baseline to 1 month after treatment
- Patient's report [ Time Frame: Change from baseline to 3 month ] [ Designated as safety issue: Yes ]change in subjective measures form baseline to 3 month after treatment
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: rTMS intervention group
The rTMS intervention group undergo ten session of real TMS therapy.
|
Device: rTMS
Patients undergone 10 session of high-frequency rTMS therapy over their left DLPFC
Other Name: repetitive transcranial magnetic stimulation
|
|
Placebo Comparator: Sham group
Patients will undergo ten session of sham rTMS.
|
Device: sham rTMS
Patients will undergo ten session of sham rTMS.
Other Name: sham repetitive transcranial magnetic stimulation
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinically diagnosed borderline personality disorder according to DSM IV.
Exclusion Criteria:
- Epilepsy
- Any metal device
- Psychotic disorders
- Bipolar mood disorder type 1
Contacts and Locations More Information
No publications provided
| Responsible Party: | Tehran University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01602497 History of Changes |
| Other Study ID Numbers: | 90-01-30-13200 |
| Study First Received: | May 16, 2012 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Iran: Ministry of Health |
Keywords provided by Tehran University of Medical Sciences:
|
Borderline personality disorder repetitive transcranial magnetic stimulation |
Additional relevant MeSH terms:
|
Personality Disorders Borderline Personality Disorder Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013