Trial of Effect of High-frequency Transcranial Magnetic S... | NCT01602497

Studies
Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder

NCT01602497

Sponsor

Tehran University of Medical Sciences

Status

Unknown status

Last Update Posted

May 21, 2012Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Borderline Personality Disorder

Interventions

rTMS
sham rTMS

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Jul 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

May 16, 2012

First Submission Date that Met QC Criteria

May 18, 2012

First Posted Date

May 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2012

Last Update Posted Date

May 21, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rTMS intervention group	Active Comparator	The rTMS intervention group undergo ten session of real TMS therapy.	Device: rTMS
Sham group	Placebo Comparator	Patients will undergo ten session of sham rTMS.	Device: sham rTMS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rTMS	Device	Patients undergone 10 session of high-frequency rTMS therapy over their left DLPFC	rTMS intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patients' reports	changes in subjective measures from baseline to tenth day of treatment	Change from baseline to two weeks

Secondary Outcomes

Measure	Description	Time Frame
patient's report	change in subjective measures from baseline to 1 month after treatment	Change from baseline to 1 month
Patient's report	change in subjective measures form baseline to 3 month after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohammad Arbabi, M.D.	Tehran University of Medical Sciences	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001883	Borderline Personality Disorder

Ancestor Terms

ID	Term
D010554	Personality Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050781	Transcranial Magnetic Stimulation

Ancestor Terms

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided