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
Transcranial direct current stimulation: A consecutive 5-days course of tDCS will be delivered. In treatment group, true stimulation will be administrated and sham stimulation will be delivered in control group.
Study 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
Sex
ALL
Min age
20 Years
Max age
90 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Electroencephalogram recording before and after the tDCS session — baseline / 2 days, 2 and 4 weeks after the end of the tDCS session Gait recording by 64 channels EEG device. Four different frequency bands ( theta, alpha, beta, and gamma) will be investigated. Variables in gait analysis: 1.Gait initiation, 2.Level walking, 3.Gait termination.
Electromyography recording before and after the tDCS session — baseline / 2 days, 2 and 4 weeks after the end of the tDCS session The 4 pairs of leg EMG recording during 50 meters walking. The EMG signals will be filtered with a band pass ranging from 0.05 to 70 Hz. Variables in gait analysis: 1.Gait initiation, 2.Level walking, 3.Gait termination.
Functional magnetic resonance images examination before and after the tDCS session — baseline / 2 days after the end of the tDCS session fMRI scan will be performed on a 3.0T MR imager to detect the brain BOLD signal change in FOG. When fMRI was conducted, four different video tapes will be presented to the subjects#1.normal walking, 2.normal turning, 3.FOG during forward straight walking and 4.FOG during turning.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III before and after the tDCS session UPDRS contains four parts, the third part of which is reported in this outcome. — baseline / 2 days, 2 and 4 weeks after the end of the tDCS session UPDRS contains four parts, the third part of which is reported in this outcome. Part III is clinician-scored monitored motor evaluation (14 questions, ranges from 0=normal to 4= Severe). The scoring of Part III varies between 0-56. The higher score indicates the worse motor function. Negative change from baseline values indicate improvement.
Trial sites (1)
Facility
City
Region
Status
China Medical University Hospital/Neuro Depart
Taichung
Taiwan
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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