Deep Brain Stimulation on Dual-task Gait Performance in PD
- Conditions
- Parkinson Disease
- Interventions
- Procedure: Deep brain stimulation with high frequencyProcedure: Deep brain stimulation with low frequency
- Registration Number
- NCT05314322
- Lead Sponsor
- National Yang Ming Chiao Tung University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
- Other neurological disorders
- Any major systemic, psychiatric, visual, and musculoskeletal disturbances or other causes of walking inability
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description High frequency group Deep brain stimulation with high frequency Deep brain stimulation's parameter: Frequency adjusted to 130Hz, with other parameters fixed Low frequency group Deep brain stimulation with low frequency Deep brain stimulation's parameter: Frequency adjusted to 60Hz, with other parameters fixed
- Primary Outcome Measures
Name Time Method Dual-task gait performance: Double limb support time Three days after frequency adjustment Using the OPTO gait system to evaluate double limb support time
Executive function - Inhibition control Three days after frequency adjustment Using the Stroop test to evaluate inhibition control
Dual-task gait performance: Stride length Three days after frequency adjustment Using the OPTO gait system to evaluate stride length
Non-motor symptoms Every 6-month up to 2 years Using the Non-motor Symptoms Scale (NMSS) to non-motor symptoms
Executive function - Shifting attention Three days after frequency adjustment Using the Trail Making Test to evaluate shifting attention
Executive function - Working memory Three days after frequency adjustment Using the Digit span test to evaluate working memory
Cognitive function Every 6-month up to 2 years Using the Montreal Cognitive Assessment (MoCA) to evaluate cognitive function
- Secondary Outcome Measures
Name Time Method Brain activity: Supplementary Motor Cortex Three days after frequency adjustment 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 Three days after frequency adjustment Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Premotor Cortex with the formula: Hb diff=HbO-HbR
Functional activity: Lower limb function Every 6-month up to 2 years Using the 30s Chair Stand Test to evaluate functional activity
Usual gait performance: Double limb support time Three days after frequency adjustment Using the OPTO gait system to evaluate double limb support time
Functional activity: Gait and balance performance Every 6-month up to 2 years Using the Timed up and go test to evaluate functional activity
Balance performance Every 6-month up to 2 years Using the Mini-BEST test to evaluate balance performance
Motor symptoms Every 6-month up to 2 years Using the Unified Parkinson's Disease Rating Scale (UPDRS) part 3 to evaluate motor symptoms
Brain activity: Prefrontal Cortex Three days after frequency adjustment Using Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Prefrontal Cortex with the formula: Hb diff=HbO-HbR
Parkinson's Disease patients' Quality of life Every 6-month up to 2 years Using the Parkinson's Disease Questionnaire (PDQ-39) evaluate quality of life
Usual gait performance: Stride length Three days after frequency adjustment Using the OPTO gait system to evaluate stride length
Trial Locations
- Locations (1)
Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
🇨🇳Taipei, Taiwan