UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030460 |
|---|---|
| Receipt number | R000034748 |
| Scientific Title | A 3D gait analysis after deep brain stimulation in Parkinson's disease |
| Date of disclosure of the study information | 2017/12/19 |
| Last modified on | 2023/08/01 19:40:41 |
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Basic information
Public title
A 3D gait analysis after deep brain stimulation in Parkinson's disease
Acronym
3DGA-DBS
Scientific Title
A 3D gait analysis after deep brain stimulation in Parkinson's disease
Scientific Title:Acronym
3DGA-DBS
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess and explore the efficacy of deep brain stimulations with directional modes in Parkinson's disease using 3D gait analysis system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of steps and time on 6m walking and Time up and go test after the steering of deep brain stimulation
Key secondary outcomes
Gait parameters and side effect on 6m walking and Time up and go test using 3D gait analysis system after steering of deep brain stimulation and Unified Parkinson's disease rating scale partIII
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The setting of deep brain stimulation is set to 0 mA as a placebo control.
Interventions/Control_2
To change 31 patterns of deep brain stimulation settings
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Parkinson's disease patients who was implanted bilaterally in STN with a DBS system (Vercise PC DBS System) for at least 3 months and was determined optimized programming according to standard care for at least 4weeks. The second or third segment electrode from the bottom is selected for optimized programming contact. The direction at the directional mode (0 degree, 120 degree, 240 degree) which causes pyramidal sign was identified during screening.
-Diagnosed bilateral idiopathic Parkinson's disease
-Subjects with written informed consent by their own will
Key exclusion criteria
-Any significant psychiatric problems including unrelated clinically significant depression
-Any current drug or alcohol abuse
-Any history of recurrent or unprovoked seizures.
-Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival less than 12 months.
-Subjects with "the 3rd grade: red patient" in "the grade of fall risk" of Juntendo University Hospital
-Subjects with large body frame expected not to be assisted by researchers in the case of their fall
-Subjects who was considered inappropriate to participate in this study by the researchers
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Genko |
| Middle name | |
| Last name | Oyama |
Organization
Juntendo University Hospital
Division name
Department of Neurology
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8431, JAPAN
TEL
+81-3-3813-3111
g_oyama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Genko |
| Middle name | |
| Last name | Oyama |
Organization
Juntendo University Hospital
Division name
Department of Neurology
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8431, JAPAN
TEL
+81-3-3813-3111
Homepage URL
g_oyama@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kao Corporation
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Juntendo University Hospital Institutional Review Board
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, 113-8431, JAPAN
Tel
03-5802-1584
N/A
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
順天堂大学医学部附属順天堂医院(東京都)
Juntendo University Hospital(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
https://authors.elsevier.com/sd/article/S1353-8020(23)00849-0
Publication of results
Published
Result
URL related to results and publications
https://authors.elsevier.com/sd/article/S1353-8020(23)00849-0
Number of participants that the trial has enrolled
11
Results
Eleven patients completed the study. No significant difference were observed between gait parameters during the directional, baseline, placebo, or ring modes during the six-meter-walk test (p > 0.05). During the Time up and go test, stride length was significantly different between 0 degree and other directions (p < 0.001), but no significant differences were observed for the other gait parameters.
Results date posted
| 2023 | Year | 08 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The Patients who were diagnosed with Parkinson's disease, according to the British Brain Bank criteria (including familial Parkinson's disease), were recruited. They were implanted with the Vercise PC/Vercise Gevia Deep Brain Stimulation system for at least three months and its programming has not been changed for at least four weeks.
Participant flow
The direction of the pyramidal tract was determined in the screening visit one to three months before the gait test. We set the angle at which pyramidal tract signs appeared to 0 degree. The subjects stopped their medication 12h before the walking test, and the stimulation was turned off 30 min before the walking test. The subjects who underwent bilateral subthalamic nucleus Deep Brain Stimulation with directional leads were evaluated while walking six meters and performing the time up-and-go test. The gait parameters included walking speed, stride length, and gait cycle duration, and were recorded using the gait analysis system. The gait parameters were measured for the baseline, the placebo stimulation (0mA), the directional steering in eight horizontal angles (0 degree, 45 degrees, 90 degrees, 135 degrees, 180 degrees, 225 degrees, 270 degrees, and 315 degrees), and the conventional ring mode with 1, 2, and 3 mA. The pulse width and frequency were fixed (90 ms, 130Hz) during this study. We conducted each gait assessment immediately after changing the parameters. The order of stimulation settings was randomized. Both examiner and patients were blinded for the settings. When all assessments are completed, the subjects are set to the initial Deep Brain Stimulation setting and observed for one hour to ensure no adverse events occur. After the observation, the study ended.
Adverse events
No adverse events were observed after the study.
Outcome measures
The gait parameters included walking speed, stride length, and gait cycle duration
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 09 | Month | 21 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 19 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034748
