- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01602497
Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder
May 18, 2012 updated by: Tehran University of Medical Sciences
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinically diagnosed borderline personality disorder according to DSM IV.
Exclusion Criteria:
- Epilepsy
- Any metal device
- Psychotic disorders
- Bipolar mood disorder type 1
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: rTMS intervention group
The rTMS intervention group undergo ten session of real TMS therapy.
|
Patients undergone 10 session of high-frequency rTMS therapy over their left DLPFC
Other Names:
|
PLACEBO_COMPARATOR: Sham group
Patients will undergo ten session of sham rTMS.
|
Patients will undergo ten session of sham rTMS.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients' reports
Time Frame: Change from baseline to two weeks
|
changes in subjective measures from baseline to tenth day of treatment
|
Change from baseline to two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient's report
Time Frame: Change from baseline to 1 month
|
change in subjective measures from baseline to 1 month after treatment
|
Change from baseline to 1 month
|
Patient's report
Time Frame: Change from baseline to 3 month
|
change in subjective measures form baseline to 3 month after treatment
|
Change from baseline to 3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Mohammad Arbabi, M.D., Tehran University of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (ANTICIPATED)
July 1, 2012
Study Completion (ANTICIPATED)
December 1, 2012
Study Registration Dates
First Submitted
May 16, 2012
First Submitted That Met QC Criteria
May 18, 2012
First Posted (ESTIMATE)
May 21, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
May 21, 2012
Last Update Submitted That Met QC Criteria
May 18, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90-01-30-13200
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Borderline Personality Disorder
-
University Hospital, Basel, SwitzerlandLeading House for the Latin American Region (Seed Money Grant SMG 1730)WithdrawnBorderline Personality Disorder (BPD)
-
Health Service Executive, IrelandCompletedPersonality Disorder, Borderline
-
University of EdinburghRecruitingEmotionally Unstable Personality Disorder, Borderline TypeUnited Kingdom
-
Silvia Elisa Hurtado SantiagoCompletedPersonality Disorder, BorderlineSpain
-
Health Service Executive, IrelandCompletedPersonality Disorder, Borderline
-
Hospital Universitari Vall d'Hebron Research InstituteUnknownBorderline Personality Disorder.Spain
-
Universitat Jaume IHospital de la RiberaRecruitingBorderline Personality Disorder (BPD)Spain
-
University of OldenburgProf. René Hurlemann; Jella Voelter, M.Sc.RecruitingBorderline Personality Disorder (BPD)Germany
-
NHS Greater Glasgow and ClydeUnknownBorderline Personality Disorder (BPD) | Antisocial Personality Disorder (ASPD)United Kingdom
-
Rutgers, The State University of New JerseyActive, not recruitingBorderline Personality Disorder in AdolescenceUnited States
Clinical Trials on rTMS
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Chang Gung Memorial HospitalMinistry of Science and Technology, TaiwanRecruiting
-
Chang Gung Memorial HospitalRecruiting
-
Changping LaboratoryBeijing HuiLongGuan HospitalRecruitingMajor Depressive Disorder | Severe Depression | Moderate DepressionChina
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
Centre hospitalier de Ville-Evrard, FranceRecruitingTo Evaluate the Effectiveness of Open rTMSFrance
-
Stanford UniversityRecruitingMajor Depressive DisorderUnited States
-
Bayside HealthCompletedAutistic Disorder | Asperger's DisorderAustralia
-
Prof. Dominique de Quervain, MDRecruiting
-
Changping LaboratoryWuhan Mental Health CentreRecruitingMajor Depressive Disorder | Severe Depression | Moderate DepressionChina