Clinical trial NCT05314322: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep brain stimulation
Dual-task walking
Executive function
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Dual-task gait performance: Stride length
timeFrame: Three days after frequency adjustment
measure: Dual-task gait performance: Double limb support time
timeFrame: Three days after frequency adjustment
measure: Executive function - Inhibition control
timeFrame: Three days after frequency adjustment
measure: Executive function - Shifting attention
timeFrame: Three days after frequency adjustment
measure: Executive function - Working memory
timeFrame: Three days after frequency adjustment
measure: Cognitive function
timeFrame: Every 6-month up to 2 years
measure: Non-motor symptoms
timeFrame: Every 6-month up to 2 years
Secondary outcomes:
measure: Usual gait performance: Stride length
timeFrame: Three days after frequency adjustment
measure: Usual gait performance: Double limb support time
timeFrame: Three days after frequency adjustment
measure: Brain activity: Prefrontal Cortex
timeFrame: Three days after frequency adjustment
measure: Brain activity: Supplementary Motor Cortex
timeFrame: Three days after frequency adjustment
measure: Brain activity: Premotor Cortex
timeFrame: Three days after frequency adjustment
measure: Functional activity: Gait and balance performance
timeFrame: Every 6-month up to 2 years
measure: Functional activity: Lower limb function
timeFrame: Every 6-month up to 2 years
measure: Balance performance
timeFrame: Every 6-month up to 2 years
measure: Motor symptoms
timeFrame: Every 6-month up to 2 years
measure: Parkinson's Disease patients' Quality of life
timeFrame: Every 6-month up to 2 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Study officials:
References: