Deep Brain Stimulation on Dual-task Gait Performance in PD

NCT ID: NCT05314322

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-07-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High frequency group

Deep brain stimulation's parameter: Frequency adjusted to 130Hz, with other parameters fixed

Group Type: EXPERIMENTAL

Deep brain stimulation with high frequency

Intervention Type: PROCEDURE

Deep brain stimulation implanted at the patients' Substantia Nigra

Low frequency group

Deep brain stimulation's parameter: Frequency adjusted to 60Hz, with other parameters fixed

Group Type: EXPERIMENTAL

Deep brain stimulation with low frequency

Intervention Type: PROCEDURE

Deep brain stimulation implanted at the patients' Substantia Nigra

Interventions

Deep brain stimulation with high frequency

Deep brain stimulation implanted at the patients' Substantia Nigra

Intervention Type: PROCEDURE

Deep brain stimulation with low frequency

Deep brain stimulation implanted at the patients' Substantia Nigra

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Yea-Ru Yang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Yea-Ru Yang, PhD

Role: CONTACT

yryang@nycu.edu.tw

+886-2-2876-7279

Other Identifiers

2022-02-016A

Identifier Type: -

Identifier Source: org_study_id