This study aims to evaluate effect of high frequency trans-cranial magnetic stimulation in the management of borderline personality disorder. the major exclusion criteria is the presence of Axis 1 disorders in patients. Patients will randomly be divided into sham and study groups. Patients undergone 10 session of high-frequency rTMS therapy over their left DLPFC. Subjects in sham group will receive the same protocol using a sham probe. All the subjects will be evaluated about psychological status and mood and affect using appropriate questionnaire before the TMS, after the last session, one and three months after the last sessions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012112611582N1
Registration date:2013-12-21, 1392/09/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-21, 1392/09/30
Registrant information
Name
Mohammad Arbabi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 9151
Email address
arbabi_m@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-10-10, 1391/07/19
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder Patients
Public title
Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic in research committe, Tehran University of Medical Sciences
Street address
4th floor, Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2011-04-19, 1390/01/30
Ethics committee reference number
90-01-30-13200
Health conditions studied
1
Description of health condition studied
Emotionally unstable personality disorder
ICD-10 code
F60.3
ICD-10 code description
Emotionally unstable personality disorder
Primary outcomes
1
Description
Borderline Personality Disorder Severity
Timepoint
Before the TMS- After the last session- One and three months after the last sessions
Method of measurement
Borderline Personality Disorder Severity Index
Secondary outcomes
1
Description
Depression
Timepoint
Before TMS - after the last session- One and three months after the last session
Method of measurement
Beck depression Inventory
2
Description
Anxiety
Timepoint
Before TMS - after the last session- One and three months after the last session
Method of measurement
Beck Anxiety inventory
3
Description
Impulsivity
Timepoint
Before TMS - after the last session- One and three months after the last session
Method of measurement
Barratt impulsivity index
Intervention groups
1
Description
High frequency transcranial magnetic stimulation
Category
Treatment - Devices
2
Description
Sham transcranial magnetic stimulation
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouzbeh Hospital
Full name of responsible person
Dr. Mohammad Arbabi
Street address
South Karegar Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mr. Ahmadi
Street address
Keshavarz Blvd, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Arbabi
Position
Associate Professor - Psychiatrist
Other areas of specialty/work
Street address
Rouzbeh hospital, South Karegar Street
City
Tehran
Postal code
Phone
+98 21 5541 9151
Fax
Email
marbabid@gmail.com, arbabi_m@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Arbabi
Position
Associate Professor- Psychiatrist
Other areas of specialty/work
Street address
Rouzbeh Hospital, South Karegar Street
City
Tehran
Postal code
Phone
+98 21 5541 9151
Fax
Email
marbabid@gmail.com, arbabi_m@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Arbabi
Position
Associate professor of Psychiatry
Other areas of specialty/work
Street address
South Karegar Street
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)