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
Recruiting · NCT06505460 · Interventional (participants receive a specific treatment) · Lead sponsor: China Medical University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- China Medical University Hospital/Neuro Depart - Taichung, Taiwan