Deep Brain Stimulation on Dual-task Gait Performance in PD

March 29, 2022 updated by: Yea-Ru Yang, National Yang Ming University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High frequency group
Deep brain stimulation's parameter: Frequency adjusted to 130Hz, with other parameters fixed
Procedure: Deep brain stimulation with high frequency
Deep brain stimulation implanted at the patients' Substantia Nigra
EXPERIMENTAL: Low frequency group
Deep brain stimulation's parameter: Frequency adjusted to 60Hz, with other parameters fixed
Procedure: Deep brain stimulation with low frequency
Deep brain stimulation implanted at the patients' Substantia Nigra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dual-task gait performance: Stride length
Time Frame: Three days after frequency adjustment
Using the OPTO gait system to evaluate stride length
Three days after frequency adjustment
Dual-task gait performance: Double limb support time
Time Frame: Three days after frequency adjustment
Using the OPTO gait system to evaluate double limb support time
Three days after frequency adjustment
Executive function - Inhibition control
Time Frame: Three days after frequency adjustment
Using the Stroop test to evaluate inhibition control
Three days after frequency adjustment
Executive function - Shifting attention
Time Frame: Three days after frequency adjustment
Using the Trail Making Test to evaluate shifting attention
Three days after frequency adjustment
Executive function - Working memory
Time Frame: Three days after frequency adjustment
Using the Digit span test to evaluate working memory
Three days after frequency adjustment
Cognitive function
Time Frame: Every 6-month up to 2 years
Using the Montreal Cognitive Assessment (MoCA) to evaluate cognitive function
Every 6-month up to 2 years
Non-motor symptoms
Time Frame: Every 6-month up to 2 years
Using the Non-motor Symptoms Scale (NMSS) to non-motor symptoms
Every 6-month up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usual gait performance: Stride length
Time Frame: Three days after frequency adjustment
Using the OPTO gait system to evaluate stride length
Three days after frequency adjustment
Usual gait performance: Double limb support time
Time Frame: Three days after frequency adjustment
Using the OPTO gait system to evaluate double limb support time
Three days after frequency adjustment
Brain activity: Prefrontal Cortex
Time Frame: Three days after frequency adjustment
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
Brain activity: Supplementary Motor Cortex
Time Frame: Three days after frequency adjustment
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
Brain activity: Premotor Cortex
Time Frame: Three days after frequency adjustment
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
Functional activity: Gait and balance performance
Time Frame: Every 6-month up to 2 years
Using the Timed up and go test to evaluate functional activity
Every 6-month up to 2 years
Functional activity: Lower limb function
Time Frame: Every 6-month up to 2 years
Using the 30s Chair Stand Test to evaluate functional activity
Every 6-month up to 2 years
Balance performance
Time Frame: Every 6-month up to 2 years
Using the Mini-BEST test to evaluate balance performance
Every 6-month up to 2 years
Motor symptoms
Time Frame: Every 6-month up to 2 years
Using the Unified Parkinson's Disease Rating Scale (UPDRS) part 3 to evaluate motor symptoms
Every 6-month up to 2 years
Parkinson's Disease patients' Quality of life
Time Frame: Every 6-month up to 2 years
Using the Parkinson's Disease Questionnaire (PDQ-39) evaluate quality of life
Every 6-month up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2022

Primary Completion (ANTICIPATED)

July 31, 2025

Study Completion (ANTICIPATED)

July 31, 2025

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (ACTUAL)

April 6, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-02-016A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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