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Deep Brain Stimulation on Dual-task Gait Performance in PD

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05314322
Enrollment
24
Registered
2022-04-06
Start date
2022-04-01
Completion date
2025-07-31
Last updated
2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Deep brain stimulation, Dual-task walking, Executive function

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.

Interventions

PROCEDUREDeep brain stimulation with high frequency

Deep brain stimulation implanted at the patients' Substantia Nigra

PROCEDUREDeep brain stimulation with low frequency

Deep brain stimulation implanted at the patients' Substantia Nigra

Sponsors

National Yang Ming Chiao Tung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dual-task gait performance: Stride lengthThree days after frequency adjustmentUsing the OPTO gait system to evaluate stride length
Dual-task gait performance: Double limb support timeThree days after frequency adjustmentUsing the OPTO gait system to evaluate double limb support time
Executive function - Inhibition controlThree days after frequency adjustmentUsing the Stroop test to evaluate inhibition control
Executive function - Shifting attentionThree days after frequency adjustmentUsing the Trail Making Test to evaluate shifting attention
Executive function - Working memoryThree days after frequency adjustmentUsing the Digit span test to evaluate working memory
Cognitive functionEvery 6-month up to 2 yearsUsing the Montreal Cognitive Assessment (MoCA) to evaluate cognitive function
Non-motor symptomsEvery 6-month up to 2 yearsUsing the Non-motor Symptoms Scale (NMSS) to non-motor symptoms

Secondary

MeasureTime frameDescription
Balance performanceEvery 6-month up to 2 yearsUsing the Mini-BEST test to evaluate balance performance
Usual gait performance: Stride lengthThree days after frequency adjustmentUsing the OPTO gait system to evaluate stride length
Parkinson's Disease patients' Quality of lifeEvery 6-month up to 2 yearsUsing the Parkinson's Disease Questionnaire (PDQ-39) evaluate quality of life
Motor symptomsEvery 6-month up to 2 yearsUsing the Unified Parkinson's Disease Rating Scale (UPDRS) part 3 to evaluate motor symptoms
Usual gait performance: Double limb support timeThree days after frequency adjustmentUsing the OPTO gait system to evaluate double limb support time
Brain activity: Prefrontal CortexThree days after frequency adjustmentUsing Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Prefrontal Cortex with the formula: Hb diff=HbO-HbR
Brain activity: Supplementary Motor CortexThree days after frequency adjustmentUsing Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Supplementary Motor Area with the formula: Hb diff=HbO-HbR
Brain activity: Premotor CortexThree days after frequency adjustmentUsing Functional near-infrared spectroscopy (fNIRS) to evaluate brain activity of Premotor Cortex with the formula: Hb diff=HbO-HbR
Functional activity: Gait and balance performanceEvery 6-month up to 2 yearsUsing the Timed up and go test to evaluate functional activity
Functional activity: Lower limb functionEvery 6-month up to 2 yearsUsing the 30s Chair Stand Test to evaluate functional activity

Countries

Taiwan

Contacts

Primary ContactYea-Ru Yang, PhD
yryang@nycu.edu.tw+886-2-2876-7279

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026