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
| NCT ID | NCT06505460 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China Medical University Hospital |
| Condition | Transcranial Direct Current Stimulation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-04-30 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-04-30 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06505460 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 90 Years, studying Transcranial Direct Current Stimulation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06505460 currently recruiting?
Yes, NCT06505460 is actively recruiting participants. Contact the research team at 008079@tool.caaumed.org.tw for enrollment information.
Where is the NCT06505460 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT06505460 clinical trial?
NCT06505460 is sponsored by China Medical University Hospital. The trial plans to enroll 20 participants.