rTMS-induced Cumulative Pattern of sBDNF in Chronic Schiz... | NCT01427088

Studies
rTMS-induced Cumulative Pattern of sBDNF in Chronic Schizophrenia

NCT01427088

Sponsor

Jeonbuk Provincial Maeumsarang Hospital

Status

Completed

Last Update Posted

Feb 18, 2015Estimated

Enrollment

21Actual

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

CR Technology, TAMAS for repetitive TMS

Countries

South Korea

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

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Aug 28, 2011

First Submission Date that Met QC Criteria

Aug 30, 2011

First Posted Date

Sep 1, 2011Estimated

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

Feb 15, 2015

Last Update Posted Date

Feb 18, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

HWANG TAEYOUNG, Director, Insan Research Center for Psychiatry, Jeonbuk Provincial Maeumsarang HospitalPrincipal Investigator

Lead Sponsor

Jeonbuk Provincial Maeumsarang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 aims at investigating the neuroplastic potential and the possible factors affecting rehabilitation in chronic schizophrenia patients on stable medication, by investigating the cumulative pattern of serum BDNF representing the neuroplasticity in the brain, through quantitative stimulus such as rTMS.

Detailed Description

Subjects who have been enrolled for this study will take baseline evaluation for sociodemographic data and serum level of BDNF, plasma Prolaction, and magnesium, etc. And then, weekday regular stimulation through rTMS will be applied on DLPFC of brain. After the completion of stimulation for 2 weeks, the change or response of serum BDNF will be analyzed and compared.

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

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
repetitive TMS	Experimental	repetitive TMS is a quantified stimulation method of specifie area of brain, for which CR Technology, TAMAS for repetitive TMS was used.	Device: CR Technology, TAMAS for repetitive TMS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CR Technology, TAMAS for repetitive TMS	Device	repetitive TMS, lef DLPFC, 20Hz, 100% of MEP, 2weeks	repetitive TMS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change from baseline of serum BDNF concentration		baseline-1 week-2 week-4 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

duration of illness over 10 years
on stable medication, antipsychotics
no change on medication within at least 2 weeks
Diagnosis of Schizophrenia according to DSM-IV-TR

Exclusion Criteria:

left or both-handedness
anticonvulsant use
lorazepam equivalent over 3 mg

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
TAEYOUNG HWANG, M.D., M.P.H.	Jeonbuk Provincial Maeumsarang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jeonbuk Provincial Maeumsarang Hospital		Wanju	Jeollabuk-do	565844	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided