UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019481 |
|---|---|
| Receipt number | R000021518 |
| Scientific Title | An exploratory study for the development of novel individually optimized treatment using transcranial magnetic stimulation (TMS) for patients with mood disorders |
| Date of disclosure of the study information | 2015/10/23 |
| Last modified on | 2022/10/28 09:50:05 |
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Basic information
Public title
An exploratory study for the development of novel individually optimized treatment using transcranial magnetic stimulation (TMS) for patients with mood disorders
Acronym
The development of novel treatment using transcranial magnetic stimulation for patients with mood disorders
Scientific Title
An exploratory study for the development of novel individually optimized treatment using transcranial magnetic stimulation (TMS) for patients with mood disorders
Scientific Title:Acronym
The development of novel treatment using transcranial magnetic stimulation for patients with mood disorders
Region
| Japan |
Condition
Condition
Mood disorders (major depressive disorder and bipolar disorder) and healthy volunteers
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify changes in brain activity following TMS interventions against patients with mood disorder and to explore novel methodological approaches that effectively improve treatment effect
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using psychological assessments and neuroimaging techniques, we evaluate psychological and neural changes in depression-related symptoms, immediately after the intervention, one week later, one month later, and again six months later.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
For depressive patients, repetitive TMS will be applied with the following parameters below.
Target location: left dorsolateral prefrontal cortex localized by a spatial navigation system
Stimulation frequency: ~10Hz
Stimulation intensity: ~120% of individual's resting motor threshold
Number of pulses: 2000-3000 pulses/day
Number of total sessions: 20-30 sessions
Interventions/Control_2
For healthy-control individuals, causally examine regionally interconnected brain regions by single-pulse TMS during a session (rather than after multiple sessions).
Interventions/Control_3
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
For patients/clients
1) Aged 20-80 years old
2) Being diagnosed as major depressive disorder or bipolar disorder (Type I, Type II) according to DSM-IV-TR or DSM-5
3) Current diagnosis of major depressive episode
4) Present treatment-resistance (scores with 14 points or above out of 17 items on the Hamilton Rating Scale for Depression even after >=4 weeks of treatment with sufficient amount of more than1 anti-depressant) or low treatment-tolerance (insufficient administration due to side-effects while taking more than 1 anti-depressant)
5) Satisfactory informed consent obtained from participant him/herself
For healthy control
1) Aged 20-80 years old
2) No history of any psychiatric disorders
3) Not having current serious medical illness
4) Satisfactory informed consent obtained from the participant him/herself
Key exclusion criteria
Rejection criteria common to both patients and healthy controls
1) Decisionally impaired individuals who has diminished capacity to understand the aim of the research
2) Physically impaired individuals who are not able to complete the experiments
3) Subjects who are contraindicated for the use of TMS and MRI
Having an implanted heart pace-maker
Having implanted cerebral (arteries) clips
Having implanted neural/nerve stimulators
Having implanted pumps
Having work experience in a metal industry or possibility of metal residues remaining in the body
Having metal-tattoos (including tattooed eye-lining)
Being pregnant, or having possibility of being pregnant
4) Subjects who are contraindicated for the use of TMS
Personal history of seizure disorder such as epileptic disorder
5) Any individuals judged as inappropriate for the experiment by the principal investigator or a collaborating researcher
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yasumasa |
| Middle name | |
| Last name | Okamoto |
Organization
Graduate school of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Psychiatry and Neurosciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minamiku, Hiroshima, 734-8553, Japan
TEL
082-257-5205
oy@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Go |
| Middle name | |
| Last name | Okada |
Organization
IGraduate school of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Psychiatry and Neurosciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minamiku, Hiroshima, 734-8553, Japan
TEL
082-257-5814
Homepage URL
goookada@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Psychiatry and Neurosciences, Graduate school of Biomedical and Health Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3 Kasumi, Minamiku, Hiroshima
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.ac.jp
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
| 2015 | Year | 10 | Month | 23 | 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
| 2015 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 23 | Day |
Last modified on
| 2022 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021518
