Deep Brain Stimulation on Dual-task Gait Performance in PD

NCT05314322 | Unknown

• 1 other identifier: 2022-02-016A
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Deep brain stimulation; Dual-task walking; Executive function

Outcome Measures

Primary Outcomes (7)

• Dual-task gait performance: Stride length

  Using the OPTO gait system to evaluate stride length

  Three days after frequency adjustment

• Dual-task gait performance: Double limb support time

  Using the OPTO gait system to evaluate double limb support time

  Three days after frequency adjustment

• Executive function - Inhibition control

  Using the Stroop test to evaluate inhibition control

  Three days after frequency adjustment

• Executive function - Shifting attention

  Using the Trail Making Test to evaluate shifting attention

  Three days after frequency adjustment

• Executive function - Working memory

  Using the Digit span test to evaluate working memory

  Three days after frequency adjustment

• Cognitive function

  Using the Montreal Cognitive Assessment (MoCA) to evaluate cognitive function

  Every 6-month up to 2 years

• Non-motor symptoms

  Using the Non-motor Symptoms Scale (NMSS) to non-motor symptoms

  Every 6-month up to 2 years

Secondary Outcomes (10)

• Usual gait performance: Stride length

  Three days after frequency adjustment

• Usual gait performance: Double limb support time

  Three days after frequency adjustment

• Brain activity: Prefrontal Cortex

  Three days after frequency adjustment

• Brain activity: Supplementary Motor Cortex

  Three days after frequency adjustment

• Brain activity: Premotor Cortex

  Three days after frequency adjustment

Study Arms (2)

High frequency group

EXPERIMENTAL

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

Procedure: Deep brain stimulation with high frequency

Low frequency group

EXPERIMENTAL

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

Procedure: Deep brain stimulation with low frequency

Interventions

Deep brain stimulation with high frequency PROCEDURE

Deep brain stimulation implanted at the patients' Substantia Nigra

High frequency group

Deep brain stimulation with low frequency PROCEDURE

Deep brain stimulation implanted at the patients' Substantia Nigra

Low frequency group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other neurological disorders
• Any major systemic, psychiatric, visual, and musculoskeletal disturbances or other causes of walking inability

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

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

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Yea-Ru Yang, PhD

CONTACT

+886-2-2876-7279; yryang@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 6, 2022
• Study Start: April 1, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

TW (1)