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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
NCT06505460 · China Medical University Hospital
In plain English
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About this study
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 experiencing FOG will undergo a standardized walking protocol on the PKMAS System, acquiring simultaneous data from two angles of video recording and foot pressure. Labeled videos of FOG incidents will be inputted into an algorithm, Adaptive Fusion Algorithm for Spam Detection (AFSD), utilizing raw RGB data, optical flow data (DualTVL), and their combination for temporal segmentation.
Second, the investigators intend to pinpoint sources of FOG in PD patients through electrophysiological methods during unconstrained walking, employing a high-density 64-channel electroencephalographic ambulatory recording and motor imagery fMRI to delve into the pathophysiology of FOG under different ambulatory conditions. Effective connectivity among higher neural regions, including the basal ganglia, cerebellum, and cortical regions, will be explored. The resulting connectivity map will be overlaid with electric recording data to examine neurovascular coupling or uncoupling.
Third, the investigators plan to conduct non-invasive interventions (transcranial direct current stimulation: tDCS, magnetic resonance-guided focused ultrasound: MRgFUS) and Deep Brain Stimulation (DBS) to assess their impact on gait and FOG in PD patients. Motor imagery fMRI and electrophysiological investigations will be performed before and after treatment using the mentioned methods. Our multi-modal approach aims to unravel the complexities of FOG in PD patients, providing valuable insights and potentially benefiting those enduring the challenges posed by this debilitating symptom.
Eligibility criteria
Inclusion Criteria:
1. Patients meet the diagnosis of PD based on the established consensus criteria
2. Age above 20 years old and below 90 years
3. 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.
4. 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 Criteria:
1. Congestive heart failure (Functional III or above) or advanced cancer with distant metastasis.
2. PD at Hoehn and Yahr Stage 5.
3. DBS exclusion criteria: overt dementia or major depression.
Study design
Enrollment target: 20 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-04-30
Estimated completion: 2027-07-31
Last updated: 2024-08-21
Interventions
Device: Transcranial direct current stimulation
Primary outcomes
- • Electroencephalogram recording before and after the tDCS session (baseline / 2 days, 2 and 4 weeks after the end of the tDCS session)
- • Electromyography recording before and after the tDCS session (baseline / 2 days, 2 and 4 weeks after the end of the tDCS session)
- • Functional magnetic resonance images examination before and after the tDCS session (baseline / 2 days after the end of the tDCS session)
Sponsor
China Medical University Hospital · other
With: Ministry of Science and Technology, Taiwan
Contacts & investigators
ContactChon-Haw Tsai, PHD · contact · 008079@tool.caaumed.org.tw · 8864-22052121
All locations (1)
China Medical University Hospital/Neuro DepartRecruiting
Taichung, Taiwan