Actively Recruiting
Exploring Non-invasive and Invasive Neuromodulation Effects on Freezing of Gait in Parkinson's Disease Using Electrophysiology and fMRI
Led by China Medical University Hospital · Updated on 2024-08-21
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
China Medical University Hospital
Lead Sponsor
M
Ministry of Science and Technology, Taiwan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Freezing of gait (FOG) is a severe symptom experienced by people with Parkinson's disease (PD), causing brief moments where walking becomes difficult or impossible. The exact cause of FOG is not fully understood but may involve disturbances in brain areas responsible for movement. This condition often appears more during complex movements like turning rather than straightforward walking. Researchers aim to better understand and measure these walking difficulties using new scientific tools over a three-year study period. The study involves developing an artificial intelligence algorithm to detect and measure FOG episodes using video and foot pressure data collected during walking tests. Researchers will also use brain activity recordings with a 64-channel EEG and motor imagery fMRI to study the brain's role in FOG during different walking conditions. Additionally, the study will evaluate the effects of treatments including transcranial direct current stimulation (tDCS), magnetic resonance-guided focused ultrasound (MRgFUS), and Deep Brain Stimulation (DBS) on gait and FOG symptoms. The tDCS treatment involves daily stimulation sessions of 2.0 mA for up to 20 minutes over five days. Participants will be monitored through various assessments including EEG and electromyography recordings, brain imaging, and clinical rating scales such as the Unified Parkinson's Disease Rating Scale (UPDRS) and questionnaires focused on gait and freezing symptoms. These measurements will be taken before treatment and at several time points after treatment, up to four weeks. The study uses a randomized, quadruple-blind design to compare real and sham tDCS stimulation. The total study duration extends up to several weeks, with ongoing safety and effectiveness monitoring to better understand and potentially improve management of FOG in PD patients.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with Parkinson's disease based on established consensus criteria
- Age between 20 and 90 years old
- For MRgFUS patients: At least one cardinal symptom (akinesia, tremor, rigidity) with intensity ≥ 2/4
- Parkinsonian symptoms not well controlled by optimal medication including L-dopa
- Stable Parkinson's medication for at least 30 days
- For DBS patients: Parkinson's disease duration over 5 years
- Positive response to levodopa with ≥33% improvement in UPDRS motor score
- Presence of motor complications such as wearing off, on-off fluctuations, levodopa-related dyskinesia, or medically intractable tremor
You will not qualify if you...
- Congestive heart failure (Functional class III or higher) or advanced metastatic cancer
- Parkinson's disease at Hoehn and Yahr Stage 5
- For DBS patients: presence of overt dementia or major depression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive a consecutive 5-day course of transcranial direct current stimulation (tDCS), either true or sham stimulation, to assess its impact on freezing of gait in Parkinson's disease.
5 daily visits (in-person) for tDCS sessions
Duration - 4 weeks
Participants undergo assessments including electroencephalogram, electromyography, functional magnetic resonance imaging, and clinical evaluations at multiple time points after treatment to monitor changes.
3 visits at 2 days, 2 weeks, and 4 weeks post-treatment
Trial Site Locations
Total: 1 location
1
China Medical University Hospital/Neuro Depart
Taichung, Taiwan, 40447
Actively Recruiting
Research Team
C
Chon-Haw Tsai, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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