Deep Brain Stimulation on Dual-task Gait Performance in PD

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05314322
• Other study ID #: 2022-02-016A
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2022
• Source: National Yang Ming University
• Contact: Yea-Ru Yang, PhD
• Phone: +886-2-2876-7279
• Email: yryang[@]nycu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• Deep brain stimulation with high frequency
Deep brain stimulation implanted at the patients' Substantia Nigra
• Deep brain stimulation with low frequency
Deep brain stimulation implanted at the patients' Substantia Nigra

Locations

Country	Name	City	State
Taiwan	Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dual-task gait performance: Stride length	Using the OPTO gait system to evaluate stride length	Three days after frequency adjustment
Primary	Dual-task gait performance: Double limb support time	Using the OPTO gait system to evaluate double limb support time	Three days after frequency adjustment
Primary	Executive function - Inhibition control	Using the Stroop test to evaluate inhibition control	Three days after frequency adjustment
Primary	Executive function - Shifting attention	Using the Trail Making Test to evaluate shifting attention	Three days after frequency adjustment
Primary	Executive function - Working memory	Using the Digit span test to evaluate working memory	Three days after frequency adjustment
Primary	Cognitive function	Using the Montreal Cognitive Assessment (MoCA) to evaluate cognitive function	Every 6-month up to 2 years
Primary	Non-motor symptoms	Using the Non-motor Symptoms Scale (NMSS) to non-motor symptoms	Every 6-month up to 2 years
Secondary	Usual gait performance: Stride length	Using the OPTO gait system to evaluate stride length	Three days after frequency adjustment
Secondary	Usual gait performance: Double limb support time	Using the OPTO gait system to evaluate double limb support time	Three days after frequency adjustment
Secondary	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
Secondary	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
Secondary	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
Secondary	Functional activity: Gait and balance performance	Using the Timed up and go test to evaluate functional activity	Every 6-month up to 2 years
Secondary	Functional activity: Lower limb function	Using the 30s Chair Stand Test to evaluate functional activity	Every 6-month up to 2 years
Secondary	Balance performance	Using the Mini-BEST test to evaluate balance performance	Every 6-month up to 2 years
Secondary	Motor symptoms	Using the Unified Parkinson's Disease Rating Scale (UPDRS) part 3 to evaluate motor symptoms	Every 6-month up to 2 years
Secondary	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