UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013533 |
|---|---|
| Receipt number | R000015818 |
| Scientific Title | Remodeling of neural networks in the treatment of geriatric depression using deep transcranial magnetic stimulation (DTMS): a preliminary study |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2015/03/28 15:40:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Remodeling of neural networks in the treatment of geriatric depression using deep transcranial magnetic stimulation (DTMS): a preliminary study
Acronym
Remodeling of neural networks in the treatment of geriatric depression using deep transcranial magnetic stimulation (DTMS): a preliminary study
Scientific Title
Remodeling of neural networks in the treatment of geriatric depression using deep transcranial magnetic stimulation (DTMS): a preliminary study
Scientific Title:Acronym
Remodeling of neural networks in the treatment of geriatric depression using deep transcranial magnetic stimulation (DTMS): a preliminary study
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of deep transcranial magnetic stimulation (DTMS) in the treatment of geriatric patients with treatment-resistant depression
Basic objectives2
Others
Basic objectives -Others
To investigate the remodeling of neural networks in the treatment of geriatric patients with treatment-resistant depression and a correlation with treatment response to DTMS
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
HDRS 17
Key secondary outcomes
CGI, MMSE, stroop test, verbal fluency, trail making test, logical memory (WMS)
fMRI, fNIRS, high-density EEG
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
DTMS is administered using deep TMS (DTMS). Stimulation parameter is set at 120% MT with 18 Hz for 2 sec, with intervals of 20 sec (2700 pulses, 75 sessions, 27.5 min).
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
DSM-V diagnosis of major depressive disorder
Aged 65-85 y/o
HDRS 17 score greater than 18
Insufficient clinical benefit to 1-4 adequate medication trials in the current episode
Key exclusion criteria
Bipolar disorder, OCD, and PTSD
Previous treatment with VNS and DBS
Pregnancy
Personal or close family history of seizure disorder
Neurologic disorder, organic brain disease
Substance or alcohol dependence
Ferromagnetic material in body or close to head
Severe metabolic disease, endocrine disease
Active suicide idea
Taking medications known to lower seizure threshold
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Kito |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL
+81-422-47-5511
kito@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Kito |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
Mitaka, Tokyo 181-8611, Japan
TEL
+81-422-47-5511
Homepage URL
kito@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
杏林大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 01 | 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 | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 27 | Day |
Last modified on
| 2015 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015818
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
