UMIN-CTR Clinical Trial

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

Parkinson's disease

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

Email

g_oyama@juntendo.ac.jp

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

Email

g_oyama@juntendo.ac.jp

Institute

Juntendo University Hospital

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Kao Corporation

Name of secondary funder(s)

None

Organization

Juntendo University Hospital Institutional Review Board

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo, 113-8431, JAPAN

Tel

03-5802-1584

Email

N/A

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

順天堂大学医学部附属順天堂医院(東京都)
Juntendo University Hospital(Tokyo)

Date of disclosure of the study information

2017

Year

12

Month

19

Day

URL releasing protocol

https://authors.elsevier.com/sd/article/S1353-8020(23)00849-0

Publication of results

Published

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

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 related 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