Deep Brain Stimulation on Dual-task Gait Performance in PD
Primary Purpose
Parkinson Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Deep brain stimulation with high frequency
Deep brain stimulation with low frequency
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Deep brain stimulation, Dual-task walking, Executive function
Eligibility Criteria
Inclusion Criteria:
- Idiopathic PD
- Age: 50~80 yrs old
- Hoehn and Yahr stage ≤ IV after DBS operation
- Implanted DBS system for at least 6 months
- MMSE ≥24
Exclusion Criteria:
- Other neurological disorders
- Any major systemic, psychiatric, visual, and musculoskeletal disturbances or other causes of walking inability
Sites / Locations
- Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High frequency group
Low frequency group
Arm Description
Deep brain stimulation's parameter: Frequency adjusted to 130Hz, with other parameters fixed
Deep brain stimulation's parameter: Frequency adjusted to 60Hz, with other parameters fixed
Outcomes
Primary Outcome Measures
Dual-task gait performance: Stride length
Using the OPTO gait system to evaluate stride length
Dual-task gait performance: Double limb support time
Using the OPTO gait system to evaluate double limb support time
Executive function - Inhibition control
Using the Stroop test to evaluate inhibition control
Executive function - Shifting attention
Using the Trail Making Test to evaluate shifting attention
Executive function - Working memory
Using the Digit span test to evaluate working memory
Cognitive function
Using the Montreal Cognitive Assessment (MoCA) to evaluate cognitive function
Non-motor symptoms
Using the Non-motor Symptoms Scale (NMSS) to non-motor symptoms
Secondary Outcome Measures
Usual gait performance: Stride length
Using the OPTO gait system to evaluate stride length
Usual gait performance: Double limb support time
Using the OPTO gait system to evaluate double limb support time
Brain activity: Prefrontal Cortex
Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Prefrontal Cortex with the formula: Hb diff=HbO-HbR
Brain activity: Supplementary Motor Cortex
Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Supplementary Motor Area with the formula: Hb diff=HbO-HbR
Brain activity: Premotor Cortex
Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Premotor Cortex with the formula: Hb diff=HbO-HbR
Functional activity: Gait and balance performance
Using the Timed up and go test to evaluate functional activity
Functional activity: Lower limb function
Using the 30s Chair Stand Test to evaluate functional activity
Balance performance
Using the Mini-BEST test to evaluate balance performance
Motor symptoms
Using the Unified Parkinson's Disease Rating Scale (UPDRS) part 3 to evaluate motor symptoms
Parkinson's Disease patients' Quality of life
Using the Parkinson's Disease Questionnaire (PDQ-39) evaluate quality of life
Full Information
NCT ID
NCT05314322
First Posted
March 16, 2022
Last Updated
March 29, 2022
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT05314322
Brief Title
Deep Brain Stimulation on Dual-task Gait Performance in PD
Official Title
The Impacts of Deep Brain Stimulation on Dual-task Gait Performance in Parkinson's Disease: Focusing on Long-term Outcome and the Effects of Stimulation Modes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's disease. Motor symptoms include rigidity, bradykinesia, tremor, and postural instability, these motor symptoms can cause gait dysfunction. Non-motor symptoms include depression, dysarthria, cognitive disability, and sleep disturbance. Although these symptoms can be improved through drug treatment, when the course of PD reaches the middle to late stage, it will still face the situation of weakened drug efficacy and the drug side effects increased. When medication can no longer adequately control the motor symptoms of PD, deep brain stimulation (DBS) becomes a powerful option. DBS is a surgical treatment that involves implanting one or more electrodes into specific areas of the brain, which deliver electrical stimulation to regulate or destroy abnormal neural signal patterns in the target area. The effect of DBS has been proven whether it is in improving motor-related symptoms or non-motor-related symptoms, but there are still some areas that have not been compared before and after the surgery, such as: gait variability, executive functions and dual-task walking. In addition, the parameters of electrical stimulation for DBS will also affect the clinical characteristics of patients. Due to the large difference between individual cases, the recommendation of the electrical stimulation frequency still not be established. Therefore, the influence of DBS and its parameters on the symptoms of PD is a topic worthy of discussion. Purposes: (1) To investigate the long-term effects of DBS on the symptoms of PD. (2) To investigate the effects of DBS stimulation frequencies on walking performance and executive function in individuals with PD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Deep brain stimulation, Dual-task walking, Executive function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High frequency group
Arm Type
Experimental
Arm Description
Deep brain stimulation's parameter: Frequency adjusted to 130Hz, with other parameters fixed
Arm Title
Low frequency group
Arm Type
Experimental
Arm Description
Deep brain stimulation's parameter: Frequency adjusted to 60Hz, with other parameters fixed
Intervention Type
Procedure
Intervention Name(s)
Deep brain stimulation with high frequency
Intervention Description
Deep brain stimulation implanted at the patients' Substantia Nigra
Intervention Type
Procedure
Intervention Name(s)
Deep brain stimulation with low frequency
Intervention Description
Deep brain stimulation implanted at the patients' Substantia Nigra
Primary Outcome Measure Information:
Title
Dual-task gait performance: Stride length
Description
Using the OPTO gait system to evaluate stride length
Time Frame
Three days after frequency adjustment
Title
Dual-task gait performance: Double limb support time
Description
Using the OPTO gait system to evaluate double limb support time
Time Frame
Three days after frequency adjustment
Title
Executive function - Inhibition control
Description
Using the Stroop test to evaluate inhibition control
Time Frame
Three days after frequency adjustment
Title
Executive function - Shifting attention
Description
Using the Trail Making Test to evaluate shifting attention
Time Frame
Three days after frequency adjustment
Title
Executive function - Working memory
Description
Using the Digit span test to evaluate working memory
Time Frame
Three days after frequency adjustment
Title
Cognitive function
Description
Using the Montreal Cognitive Assessment (MoCA) to evaluate cognitive function
Time Frame
Every 6-month up to 2 years
Title
Non-motor symptoms
Description
Using the Non-motor Symptoms Scale (NMSS) to non-motor symptoms
Time Frame
Every 6-month up to 2 years
Secondary Outcome Measure Information:
Title
Usual gait performance: Stride length
Description
Using the OPTO gait system to evaluate stride length
Time Frame
Three days after frequency adjustment
Title
Usual gait performance: Double limb support time
Description
Using the OPTO gait system to evaluate double limb support time
Time Frame
Three days after frequency adjustment
Title
Brain activity: Prefrontal Cortex
Description
Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Prefrontal Cortex with the formula: Hb diff=HbO-HbR
Time Frame
Three days after frequency adjustment
Title
Brain activity: Supplementary Motor Cortex
Description
Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Supplementary Motor Area with the formula: Hb diff=HbO-HbR
Time Frame
Three days after frequency adjustment
Title
Brain activity: Premotor Cortex
Description
Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Premotor Cortex with the formula: Hb diff=HbO-HbR
Time Frame
Three days after frequency adjustment
Title
Functional activity: Gait and balance performance
Description
Using the Timed up and go test to evaluate functional activity
Time Frame
Every 6-month up to 2 years
Title
Functional activity: Lower limb function
Description
Using the 30s Chair Stand Test to evaluate functional activity
Time Frame
Every 6-month up to 2 years
Title
Balance performance
Description
Using the Mini-BEST test to evaluate balance performance
Time Frame
Every 6-month up to 2 years
Title
Motor symptoms
Description
Using the Unified Parkinson's Disease Rating Scale (UPDRS) part 3 to evaluate motor symptoms
Time Frame
Every 6-month up to 2 years
Title
Parkinson's Disease patients' Quality of life
Description
Using the Parkinson's Disease Questionnaire (PDQ-39) evaluate quality of life
Time Frame
Every 6-month up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Idiopathic PD
Age: 50~80 yrs old
Hoehn and Yahr stage ≤ IV after DBS operation
Implanted DBS system for at least 6 months
MMSE ≥24
Exclusion Criteria:
Other neurological disorders
Any major systemic, psychiatric, visual, and musculoskeletal disturbances or other causes of walking inability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yea-Ru Yang, PhD
Phone
+886-2-2876-7279
Email
yryang@nycu.edu.tw
Facility Information:
Facility Name
Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Deep Brain Stimulation on Dual-task Gait Performance in PD
We'll reach out to this number within 24 hrs