Deep Brain Stimulation on Dual-task Gait Performance in PD

Sponsor
National Yang Ming University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05314322
Collaborator
(none)
24
1
2
40
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Deep brain stimulation with high frequency
  • Procedure: Deep brain stimulation with low frequency
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Jul 31, 2025
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Dual-task gait performance: Stride length [Three days after frequency adjustment]

    Using the OPTO gait system to evaluate stride length

  2. Dual-task gait performance: Double limb support time [Three days after frequency adjustment]

    Using the OPTO gait system to evaluate double limb support time

  3. Executive function - Inhibition control [Three days after frequency adjustment]

    Using the Stroop test to evaluate inhibition control

  4. Executive function - Shifting attention [Three days after frequency adjustment]

    Using the Trail Making Test to evaluate shifting attention

  5. Executive function - Working memory [Three days after frequency adjustment]

    Using the Digit span test to evaluate working memory

  6. Cognitive function [Every 6-month up to 2 years]

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

  7. Non-motor symptoms [Every 6-month up to 2 years]

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

Secondary Outcome Measures

  1. Usual gait performance: Stride length [Three days after frequency adjustment]

    Using the OPTO gait system to evaluate stride length

  2. Usual gait performance: Double limb support time [Three days after frequency adjustment]

    Using the OPTO gait system to evaluate double limb support time

  3. Brain activity: Prefrontal Cortex [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

  4. Brain activity: Supplementary Motor Cortex [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

  5. Brain activity: Premotor Cortex [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

  6. Functional activity: Gait and balance performance [Every 6-month up to 2 years]

    Using the Timed up and go test to evaluate functional activity

  7. Functional activity: Lower limb function [Every 6-month up to 2 years]

    Using the 30s Chair Stand Test to evaluate functional activity

  8. Balance performance [Every 6-month up to 2 years]

    Using the Mini-BEST test to evaluate balance performance

  9. Motor symptoms [Every 6-month up to 2 years]

    Using the Unified Parkinson's Disease Rating Scale (UPDRS) part 3 to evaluate motor symptoms

  10. Parkinson's Disease patients' Quality of life [Every 6-month up to 2 years]

    Using the Parkinson's Disease Questionnaire (PDQ-39) evaluate quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University Taipei Taiwan 112

Sponsors and Collaborators

  • National Yang Ming University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yea-Ru Yang, Professor, National Yang Ming University
ClinicalTrials.gov Identifier:
NCT05314322
Other Study ID Numbers:
  • 2022-02-016A
First Posted:
Apr 6, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yea-Ru Yang, Professor, National Yang Ming University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022