Deep Brain Stimulation on Dual-task Gait Performance in PD

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Procedure: Deep brain stimulation with high frequency
* Procedure: Deep brain stimulation with low frequency


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High frequency group<br>Deep brain stimulation's parameter: Frequency adjusted to 130Hz, with other parameters fixed | Procedure: Deep brain stimulation with high frequency<br>* Deep brain stimulation implanted at the patients' Substantia Nigra<br>|
| Experimental: Low frequency group<br>Deep brain stimulation's parameter: Frequency adjusted to 60Hz, with other parameters fixed | Procedure: Deep brain stimulation with low frequency<br>* Deep brain stimulation implanted at the patients' Substantia Nigra<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual-task gait performance: Stride length | Using the OPTO gait system to evaluate stride length | Three days after frequency adjustment | 
| Dual-task gait performance: Double limb support time | Using the OPTO gait system to evaluate double limb support time | Three days after frequency adjustment | 
| Executive function - Inhibition control | Using the Stroop test to evaluate inhibition control | Three days after frequency adjustment | 
| Executive function - Shifting attention | Using the Trail Making Test to evaluate shifting attention | Three days after frequency adjustment | 
| Executive function - Working memory | Using the Digit span test to evaluate working memory | Three days after frequency adjustment | 
| Cognitive function | Using the Montreal Cognitive Assessment (MoCA) to evaluate cognitive function | Every 6-month up to 2 years | 
| Non-motor symptoms | Using the Non-motor Symptoms Scale (NMSS) to non-motor symptoms | Every 6-month up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usual gait performance: Stride length | Using the OPTO gait system to evaluate stride length | Three days after frequency adjustment | 
| Usual gait performance: Double limb support time | Using the OPTO gait system to evaluate double limb support time | Three days after frequency adjustment | 
| Brain activity: Prefrontal Cortex | Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Prefrontal Cortex with the formula: Hb diff=HbO-HbR | Three days after frequency adjustment | 
| 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 | Three days after frequency adjustment | 
| Brain activity: Premotor Cortex | Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Premotor Cortex with the formula: Hb diff=HbO-HbR | Three days after frequency adjustment | 
| Functional activity: Gait and balance performance | Using the Timed up and go test to evaluate functional activity | Every 6-month up to 2 years | 
| Functional activity: Lower limb function | Using the 30s Chair Stand Test to evaluate functional activity | Every 6-month up to 2 years | 
| Balance performance | Using the Mini-BEST test to evaluate balance performance | Every 6-month up to 2 years | 
| Motor symptoms | Using the Unified Parkinson's Disease Rating Scale (UPDRS) part 3 to evaluate motor symptoms | Every 6-month up to 2 years | 
| Parkinson's Disease patients' Quality of life | Using the Parkinson's Disease Questionnaire (PDQ-39) evaluate quality of life | Every 6-month up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep brain stimulation, Dual-task walking, Executive function