A 3D gait analysis after deep brain stimulation in Parkinson's disease

UMIN ID: UMIN000030460

Registered date:19/12/2017

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 2017/12/19
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The setting of deep brain stimulation is set to 0 mA as a placebo control.
To change 31 patterns of deep brain stimulation settings

Outcome(s)

• Primary Outcome: Number of steps and time on 6m walking and Time up and go test after the steering of deep brain stimulation
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female

Exclude 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

Related Information

• Primary Sponsor: Juntendo University Hospital
• Secondary Sponsor: Kao Corporation
• Source(s) of Monetary Support: Kao Corporation,None