UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009996 |
|---|---|
| Receipt number | R000011704 |
| Scientific Title | MRI Measurement of Lead Location for Suboptimal Outcomes after Deep Brain Stimulation |
| Date of disclosure of the study information | 2013/02/27 |
| Last modified on | 2022/12/09 10:19:24 |
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Basic information
Public title
MRI Measurement of Lead Location for
Suboptimal Outcomes after Deep Brain Stimulation
Acronym
MRI trouble shooting for DBS study (MRI-DBS study)
Scientific Title
MRI Measurement of Lead Location for
Suboptimal Outcomes after Deep Brain Stimulation
Scientific Title:Acronym
MRI trouble shooting for DBS study (MRI-DBS study)
Region
| Japan |
Condition
Condition
Parkinson's disease, dystonia, tremor
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of measuring lead location by brain MRI for patients with suboptimal clinical efficacy of deep brain stimulation (DBS) and to assess efficacy of repositioning or adding DBS lead(s).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The Parkinson's Disease Questionnaire (PDQ-39)
Key secondary outcomes
1.Unified Parkinoson's Disease Rating Scale (UPDRS) part I, II, IV
2.UPDRS-III (on/off stimulation, on/off medication)
3. Impedance
4.threshoulds for efficacy and side effect of DBS
5. Beck Depression Inventory (BDI)
6. Hamilton Rating Scale for Depression (HAMD)
7. Montgomery-Asberg Depression Scale (MADRS)
8. Zung Self-rating Depression Scale (SDS)
9. Apathy scale (AS)
10. Mini-Mental State Examination (MMSE)
11. Frontal Assessment Battery (FAB)
12.Japanese version of Montreal Cognitive Assessment (MoCA-J)
13.Keio version Wisconsin card sorting test (KWCST)
14. other complications
Base
Study type
Interventional
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 | Maneuver |
Interventions/Control_1
MRI
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Include either 1 or 2:
1. Patients with suboptimal clinical efficacy after DBS therapy.
2. Patients who cannot increase DBS settings due to stimulation induced side effects.
Key exclusion criteria
Exclusion criteria are following.
1. Pregnant women and, nursing mothers
2. Patients who have cardiac pacemaker.
3. Patients who cannot understand the concept of this study or who cannot obtain written consent.
4. Patients who are assumed not to be appropriate candidate for this study by investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Shimo |
Organization
Juntendo University
Division name
Department of Research and Therapeutics for Movement Disorders
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-0033
TEL
+81-3-3813-3111-
yshimo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Genko Oyama |
Organization
Juntendo University
Division name
Department of Neurology
Zip code
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
+81-3-3813-3111
Homepage URL
g_oyama@jutendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
順天堂大学附属順天堂医院（東京）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 27 | 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
| 2013 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 07 | Day |
Last modified on
| 2022 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011704
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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