SchizophreniaNCT01427088
rTMS-induced Cumulative Pattern of sBDNF in Chronic Schizophrenia
A study testing CR Technology, TAMAS for repetitive TMS in people with Schizophrenia, run by Jeonbuk Provincial Maeumsarang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- CR Technology, TAMAS for repetitive TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- left or both-handedness
- anticonvulsant use
- lorazepam equivalent over 3 mg
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jeonbuk Provincial Maeumsarang Hospital
Wanju, Jeollabuk-do, 565844
About this study
Official title: Short-Term Response of Serum Brain-Derived Neurotrophic Factor to Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Schizophrenia
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- CR Technology, TAMAS for repetitive TMS
- Keywords
- rTMS-induced cumulative pattern of sBDNF
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CR Technology, TAMAS for repetitive TMSDevice
repetitive TMS, lef DLPFC, 20Hz, 100% of MEP, 2weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CR Technology, TAMAS for repetitive TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline of serum BDNF concentration
Measured: baseline-1 week-2 week-4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeonbuk Provincial Maeumsarang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HWANG TAEYOUNG, Jeonbuk Provincial Maeumsarang Hospital
- Investigators
- TAEYOUNG HWANG, M.D., M.P.H., Principal investigator, Jeonbuk Provincial Maeumsarang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427088
- Sponsor's protocol ID
- rTMS-sBDNF-SPR-2011
- Status last verified
- Feb 2015
- First submitted
- 28 Aug 2011
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Response of Serum Brain-Derived Neurotrophic Factor to Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Schizophrenia
- ClinicalTrials.gov ID
- NCT01427088
- Acronym / sponsor ID
- rTMS-sBDNF-SPR-2011
- Conditions
- Schizophrenia
- Keywords
- rTMS-induced cumulative pattern of sBDNF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jeonbuk Provincial Maeumsarang HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| repetitive TMS | Experimental | Device: CR Technology, TAMAS for repetitive TMSrepetitive TMS is a quantified stimulation method of specifie area of brain, for which CR Technology, TAMAS for repetitive TMS was used. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- left or both-handedness
- anticonvulsant use
- lorazepam equivalent over 3 mg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CR Technology, TAMAS for repetitive TMSrepetitive TMS, lef DLPFC, 20Hz, 100% of MEP, 2weeks | Device | repetitive TMS |
Primary outcome
change from baseline of serum BDNF concentration
Time frame: baseline-1 week-2 week-4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TAEYOUNG HWANG, M.D., M.P.H. principal investigator
Jeonbuk Provincial Maeumsarang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CR Technology, TAMAS for repetitive TMS in people with Schizophrenia, run by Jeonbuk Provincial Maeumsarang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline of serum BDNF concentration (time frame: baseline-1 week-2 week-4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.