Actively Recruiting

Phase Not Applicable
Age: 20Years - 90Years
All Genders
Healthy Volunteers
NCT06505460

Exploring the Possible Beneficial Impact of Non-invasive and Invasive Neuromodulation on Freezing of Gait in Parkinson's Disease During Different Ambulatory Complexities: An Electrophysiological and fMRI Study

Led by China Medical University Hospital · Updated on 2024-08-21

20

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

Sponsors

C

China Medical University Hospital

Lead Sponsor

M

Ministry of Science and Technology, Taiwan

Collaborating Sponsor

AI-Summary

What this Trial Is About

Freezing of gait (FOG) stands out as a devastating symptom of Parkinson's disease (PD), where patients may become momentarily glued to the ground, rendering them incapable of walking efficiently. The pathogenesis of FOG remains uncertain but is likely attributed to functional perturbations in superficial cortical and deep locomotion regions. FOG tends to manifest more prominently during complex walking, such as turning, than during simple straight forward walking, and the reasons for this phenomenon remain unclear. Unfortunately, effective methods for overcoming this ambulatory issue has yet to be identified, and quantifying paroxysmal gait spells proves challenging with clinical rating alone; thus, a scientific tool is warranted. In this 3-year proposal, the investigators plan to address these challenges comprehensively.

CONDITIONS

Official Title

Exploring the Possible Beneficial Impact of Non-invasive and Invasive Neuromodulation on Freezing of Gait in Parkinson's Disease During Different Ambulatory Complexities: An Electrophysiological and fMRI Study

Who Can Participate

Age: 20Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients meet the diagnosis of Parkinson's disease based on established consensus criteria
  • Age above 20 years old and below 90 years
  • For MRgFUS patients: at least one cardinal symptom (akinesia, tremor, rigidity) with intensity of at least 2/4
  • Parkinsonian symptoms not satisfactorily controlled by optimal medication including L-dopa
  • Stable Parkinson's medication for at least 30 days
  • DBS patients must have Parkinson's disease for more than 5 years
  • DBS patients must show at least 33% improvement in UPDRS motor score after levodopa
  • DBS patients must have motor complications such as wearing off, on-off episodes, levodopa-related dyskinesia, or intractable tremor
Not Eligible

You will not qualify if you...

  • Congestive heart failure Functional Class III or above
  • Advanced cancer with distant metastasis
  • Parkinson's disease at Hoehn and Yahr Stage 5
  • For DBS patients: overt dementia or major depression

AI-Screening

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Trial Site Locations

Total: 1 location

1

China Medical University Hospital/Neuro Depart

Taichung, Taiwan, 40447

Actively Recruiting

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Research Team

C

Chon-Haw Tsai, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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