rTMS-induced Cumulative Pattern of sBDNF in Chronic Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CR Technology, TAMAS for repetitive TMS
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia focused on measuring rTMS-induced cumulative pattern of sBDNF
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
Sites / Locations
- Jeonbuk Provincial Maeumsarang Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
repetitive TMS
Arm Description
repetitive TMS is a quantified stimulation method of specifie area of brain, for which CR Technology, TAMAS for repetitive TMS was used.
Outcomes
Primary Outcome Measures
change from baseline of serum BDNF concentration
Secondary Outcome Measures
Full Information
NCT ID
NCT01427088
First Posted
August 28, 2011
Last Updated
February 15, 2015
Sponsor
Jeonbuk Provincial Maeumsarang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01427088
Brief Title
rTMS-induced Cumulative Pattern of sBDNF in Chronic Schizophrenia
Official Title
Short-Term Response of Serum Brain-Derived Neurotrophic Factor to Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jeonbuk Provincial Maeumsarang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
rTMS-induced cumulative pattern of sBDNF
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
repetitive TMS
Arm Type
Experimental
Arm Description
repetitive TMS is a quantified stimulation method of specifie area of brain, for which CR Technology, TAMAS for repetitive TMS was used.
Intervention Type
Device
Intervention Name(s)
CR Technology, TAMAS for repetitive TMS
Intervention Description
repetitive TMS, lef DLPFC, 20Hz, 100% of MEP, 2weeks
Primary Outcome Measure Information:
Title
change from baseline of serum BDNF concentration
Time Frame
baseline-1 week-2 week-4 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TAEYOUNG HWANG, M.D., M.P.H.
Organizational Affiliation
Jeonbuk Provincial Maeumsarang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jeonbuk Provincial Maeumsarang Hospital
City
Wanju
State/Province
Jeonbuk
ZIP/Postal Code
565844
Country
Korea, Republic of
12. IPD Sharing Statement
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rTMS-induced Cumulative Pattern of sBDNF in Chronic Schizophrenia
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