NCT06505460Recruiting
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 11 Jul 2024
- Start date
- 30 Apr 2024
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- China Medical University Hospital
- Diseases
- Parkinson disease
- NCT number
- NCT06505460
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 30 Apr 2024 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Congestive heart failure (Functional III or above) or advanced cancer with distant metastasis.
- DBS exclusion criteria: overt dementia or major depression.
Other
- PD at Hoehn and Yahr Stage 5.
Who the study is looking for
- 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).
Age in the registry: 20 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China Medical University Hospital/Neuro Depart Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.