Status:
RECRUITING
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
Lead Sponsor:
China Medical University Hospital
Collaborating Sponsors:
Ministry of Science and Technology, Taiwan
Conditions:
Transcranial Direct Current Stimulation
Eligibility:
All Genders
20-90 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
First, the investigators aim to develop an artificial intelligence algorithm for the identification and quantification of FOG episodes using Red-Green-Blue (RGB) and walkway pressure data. PD patients...
Eligibility Criteria
Inclusion
- Patients meet the diagnosis of PD based on the established consensus criteria
- Age above 20 years old and below 90 years
- For MRgFUS patients: a. At least one of the 3 cardinal symptoms (akinesia, tremor, rigidity) reaches an intensity of at least 2/4. b. Parkinsonian symptoms cannot be satisfactorily controlled by optimal pharmacological treatment including L-dopa and other antiparkinsonian drugs. c. stable medication for PD ≥ 30 days.
- DBS patients must meet Taiwan Health Insurance criteria: PD duration exceeding 5 years, positive response to levodopa (≥33% UPDRS motor score improvement), and presence of motor complications (e.g., wearing off, on-off, levodopa-related dyskinesia, or medically intractable tremor).
Exclusion
- Congestive heart failure (Functional III or above) or advanced cancer with distant metastasis.
- PD at Hoehn and Yahr Stage 5.
- DBS exclusion criteria: overt dementia or major depression.
Key Trial Info
Start Date :
April 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06505460
Start Date
April 30 2024
End Date
July 31 2027
Last Update
August 21 2024
Active Locations (1)
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1
China Medical University Hospital/Neuro Depart
Taichung, Taiwan, 40447