NCT01427088

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

2 months

First QC Date

August 28, 2011

Last Update Submit

February 15, 2015

Conditions

Schizophrenia

Keywords

rTMS-induced cumulative pattern of sBDNF

Outcome Measures

Primary Outcomes (1)

  • change from baseline of serum BDNF concentration

    baseline-1 week-2 week-4 week

Study Arms (1)

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

CR Technology, TAMAS for repetitive TMSDEVICE

repetitive TMS, lef DLPFC, 20Hz, 100% of MEP, 2weeks

repetitive TMS

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeonbuk Provincial Maeumsarang Hospital

Wanju, Jeollabuk-do, 565844, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • TAEYOUNG HWANG, M.D., M.P.H.

    Jeonbuk Provincial Maeumsarang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Insan Research Center for Psychiatry

Study Record Dates

First Submitted

August 28, 2011

First Posted

September 1, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2011

Study Completion

November 1, 2011

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

KR(1)