UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013272 |
|---|---|
| Receipt number | 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 14:59:20 |
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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
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
hidehiko@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015471
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