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 Number: NCT06505460
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Transcranial Direct Current Stimulation
Interventions: DEVICE: Transcranial direct current stimulation
Sponsor: China Medical University Hospital
Collaborators: Ministry of Science and Technology, Taiwan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-30
Completion Date: 2027-07-31
Locations: China Medical University Hospital/Neuro Depart, Taichung, 40447, Taiwan

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.

Primary Outcome Measures: Electroencephalogram recording before and after 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., baseline / 2 days, 2 and 4 weeks after the end of the tDCS session|Electromyography recording before and after 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., baseline / 2 days, 2 and 4 weeks after the end of the tDCS session|Functional magnetic resonance images examination before and after 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., baseline / 2 days after the end of the tDCS session|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., 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., baseline / 2 days, 2 and 4 weeks after the end of the tDCS session
Secondary Outcome Measures: Change in New freezing of gait questionnaire (NFOG-Q) before and after the tDCS session, NFOG-Q contains three parts: in the first part, a video clip will be shown to the participants with PD and help to classify whether an individual is a freezer or non-freezer. The second and third part of the questionnaire is designed for freezers only. Par II (items 2-6, scores range between 0-19) assesses the severity of FOG according to the frequency and duration of the freezing episodes. Part III (items 7-9, scores range between 0-9) evaluates the impact of freezing on daily activities. The higher score indicates the worse freezing of gait. Negative change from baseline values indicate improvement., baseline / 2 days, 2 and 4 weeks after the end of the tDCS session|Change in Gait and Falls Questionnaire (GFQ) before and after the tDCS session, Gait and Falls Questionnaire assesses freezing of gait severity in patients with Parkinson's Disease (16 questions, ranges from 0=normal to 4= Severe). The scoring varies between 0-64. The higher score indicates the worse motor function. Negative change from baseline values indicate improvement., baseline / 2 days, 2 and 4 weeks after the end of the tDCS session
Other Outcome Measures: Change in Tinetti's Mobility Index total score before and after the tDCS session, The Tinetti's Mobility Index contains two parts, Part I is Balance tests (9 questions, scores range between 0-16) and Part II is Gait tests (7 questions, scores range between 0-12). The scoring of this scale varies between 0 and 28 (\< 19 high fall risk, 19-24 medium fall risk, 25-28 low fall risk). Positive change from baseline values indicate improvement., baseline / 4 weeks after the end of the tDCS session|Change in Berg Balance Scale before and after the tDCS session, Berg Balance Scale is clinician-scored monitored motor evaluation (14 questions, ranges from 0=normal to 4= Severe). The scoring varies between 0-56. The higher score indicates the worse motor function. Negative change from baseline values indicate improvement., baseline / 4 weeks after the end of the tDCS session|Change inParkinson's Disease Questionnaire 39 (PDQ-39) before and after the tDCS session, PDQ-39 is composed of 39 questions, divided into 8 parts: mobility, activities of daily living (ADLs), emotional wellbeing, stigma, social support, cognition, communication and physical discomfort. It assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living. All questions range from 0 to 4 (0=never, 4=always). The scoring of this scale varies between 0-156. Negative change from baseline values indicate better quality of life rating., baseline / 4 weeks after the end of the tDCS session|Non-Motor Symptoms Questionnaire (NMSQ), Non-Motor Symptoms Scale for Parkinson's Disease is composed of 30 questions, divided into 9 parts: Cardiovascular including falls, Sleep/fatigue, Mood/cognition, Perceptual problems/hallucinations, Attention/memory, Gastrointestinal tract, Urinary, Sexual function and Miscellaneous. The scoring method is frequency x severity (higher scores = more disability, lower scores = less disability). Negative change from baseline values indicate improvement., baseline / 4 weeks after the end of the tDCS session