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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013272
Receipt No. R000015471
Scientific Title A semi-crossover open trial of combined therapy of fMRI neurofeedback and repetitive transcranial magnetic stimulation (rTMS) for affective disorders.
Date of disclosure of the study information 2014/02/25
Last modified on 2014/09/25

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Basic information
Public title A semi-crossover open trial of combined therapy of fMRI neurofeedback and repetitive transcranial magnetic stimulation (rTMS) for affective disorders.
Acronym A semi-crossover open trial of combined therapy of fMRI neurofeedback and repetitive transcranial magnetic stimulation (rTMS) for affective disorders.
Scientific Title A semi-crossover open trial of combined therapy of fMRI neurofeedback and repetitive transcranial magnetic stimulation (rTMS) for affective disorders.
Scientific Title:Acronym A semi-crossover open trial of combined therapy of fMRI neurofeedback and repetitive transcranial magnetic stimulation (rTMS) for affective disorders.
Region
Japan

Condition
Condition Major depressive disorder (Monopolar depression) and bipolar disorder(Bipolar I disorder and bipolar II disorder)
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A main purpose of this clinical trial is to evaluate safety and efficacy, including antidepressant effect and prefrontal cognitive enhancement, of fMRI neurofeedback and rTMS applied to major depressive episode. Moreover, alterations induced by neurofeedback or rTMS are longitudinally investigated using fMRI.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes 1) Hamilton Depression Rating Scale (Ham-D) 17items and 24items
2) Beck Depression Inventry II (BDI-II)
3) Self-rating Depression Scale (SDS)
4) rTMS side effects questionnaire, which was translated in Japanese from original version of Center for Noninvasive Brain Stimulation, Harvard Medical School.: evaluated every rTMS session
Key secondary outcomes 5) State-Trait Anxiety Inventory (STAI)
6) Bipolar Spectrum Diganostic Scale (BSDS)
7) Neuropsychological Tests (Emotional "Face-word" Stroop Task, Four-armed Bandit Task)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 fMRI neurofeedback
Connectivity-based neurofeedback using a 3T fMRI apparatus
Interventions/Control_2 Navigation-guided high-frequency rTMS
TMS coil: air-cooled figure-of-eight coil
site: left dorsolateral prefrontal cortex (lt.DLPFC)
frequency: 10Hz (4sec. train, 26sec. interval)
intensity: 90-100% resting motor threshold (RMT)
number of pulses: 2000pulses/session
time of session: 25 minutes
number of sessions: 5 to 20 sessions (1 to 4 weeks)
Interventions/Control_3 Combined trial of two interventions listed above
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria 1. DSM-IV-TR diagnosis of major depressive disorder or bipolar disorder(BPI or II)
2. Current diagnosis of major depressive episode
3. Normal visual acuity
4. Aged 20-75 years-old, outpatients, self-sustained ADL
5. Capability of informed consent
Key exclusion criteria 1. Implanted cardiac pacemaker
2. Surgical aneurysm clips
3. Neurostimulator
4. Implanted pumps
5. Metal fragments in body/eyes
6. Tattoos or permanent eyeliner (if ink contains metallic specks)
7. Treatment history of ECT
8. Diagnosis of neurological disorders (including epilepsy), substance dependence, or
significant cardiac disease
9. History of neurological disorders (including epilepsy), substance dependence, or head injury with loss of consciousness
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidehiko Takahashi
Organization Kyoto University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 54, Kawaramachi-shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL 075-751-3386
Email hidehiko@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidehiko Takahashi
Organization Kyoto University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 54, Kawaramachi-shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL 075-751-3386
Homepage URL
Email hidehiko@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Advanced Telecommunications Research Institute International(ATR)
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2014 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 14 Day
Last follow-up date
2014 Year 09 Month 25 Day
Date of closure to data entry
2014 Year 09 Month 25 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 25 Day
Last modified on
2014 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015471

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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