Clinical Efficacy and Mechanism of tDCS for Dysphagia in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Rosenbek Penetration-Aspiration Scale (PAS):
研究概览
简要总结
This study aims to verify transcranial direct current stimulation(tDCS) efficacy for Parkinson's disease (PD)-related dysphagia and its mechanism. Subjects are randomly split into two groups: control (sham tDCS + conventional dysphagia treatment) and experimental (real tDCS + conventional treatment).
Assessments will be conducted at baseline, after the completion of intervention, and at the 3-month follow-up. Swallowing function will be evaluated via gold-standard videofluoroscopic swallowing study (VFSS) and scales. Resting-state functional magnetic resonance imaging (rs-fMRI) or functional near-infrared spectroscopy (fNIRS) will be measures for tracking changes in abnormal brain regions/networks.
Correlations between swallowing recovery and brain function changes, plus group imaging differences, will reveal tDCS's neurophysiological mechanism.
详细描述
This study aims to verify the efficacy of tDCS in treating dysphagia in PD and explore its mechanism. Subjects are randomly divided into two groups: the control group receives sham tDCS as well as the conventional dysphagia treatment, while the experimental group undergoes real tDCS combined with conventional dysphagia treatment.
All subjects will be evaluated before treatment, after treatment, and 3 months later (follow-up). Swallowing function in both groups will be assessed using the gold standard VFSS and swallowing scales. Additionally, techniques including amplitude of low frequency fluctuation (ALFF) and functional connectivity (FC) in rs-fMRI or fNIRS will be used to observe changes in abnormal brain regions and brain network connectivity before and after treatment in both groups.
This study will also explore the correlation between swallowing function recovery and the alteration of brain function, compare the imaging differences between the two groups, and thereby reveal the neurophysiological mechanism underlying tDCS in the treatment of PD-related dysphagia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the Chinese Diagnostic Criteria for Parkinson's Disease (2016) or MDS Diagnostic Criteria for Multiple System Atrophy or Progressive Supranuclear Palsy;
- •VFSS examination indicates dysphagia;
- •Mini-Mental State Examination (MMSE) score >23;
- •Willing to cooperate with the study and sign the informed consent form;
排除标准
- •Comorbid with other diseases that cause dysphagia;
- •Comorbid with pneumonia, or severe cardiac/renal insufficiency;
- •Having metal implants in the body
- •With cognitive impairment or inability to cooperate.
研究组 & 干预措施
real tDCS group
tDCS Treatment Protocol The anode of the electrode pad will be placed on the swallowing sensorimotor cortex (S1/M1). The cathode will be placed on the contralateral supraorbital margin. The S1/M1 areas of the left and right hemispheres will be stimulated alternately, with a current intensity of 1.6mA. The treatment will be given once daily, 20 minutes per session, 5 times a week, for 2 consecutive weeks, totaling 10 sessions (5 sessions for each hemisphere).
Conventional Dysphagia Treatment
- Training for perioral muscles, tongue sensory and motor functions, including ice cotton swab stimulation, gustatory stimulation, tongue muscle movement training, etc.;
- Airway protection training, including Mendelsohn maneuver, supraglottic swallow training, etc.;
干预措施: tDCS (Device)
real tDCS group
tDCS Treatment Protocol The anode of the electrode pad will be placed on the swallowing sensorimotor cortex (S1/M1). The cathode will be placed on the contralateral supraorbital margin. The S1/M1 areas of the left and right hemispheres will be stimulated alternately, with a current intensity of 1.6mA. The treatment will be given once daily, 20 minutes per session, 5 times a week, for 2 consecutive weeks, totaling 10 sessions (5 sessions for each hemisphere).
Conventional Dysphagia Treatment
- Training for perioral muscles, tongue sensory and motor functions, including ice cotton swab stimulation, gustatory stimulation, tongue muscle movement training, etc.;
- Airway protection training, including Mendelsohn maneuver, supraglottic swallow training, etc.;
干预措施: Conventional Dysphagia Treatment (Behavioral)
sham tDCS group
Sham tDCS Treatment Protocol The electrode positions and treatment frequency of sham tDCS will be the same as those of real tDCS. The current is 0.05 mA. The treatment will be given once daily, 20 minutes per session, 5 times a week, for 2 consecutive weeks, totaling 10 sessions (5 sessions for each hemisphere).
Conventional Dysphagia Treatment
- Training for perioral muscles, tongue sensory and motor functions, including ice cotton swab stimulation, gustatory stimulation, tongue muscle movement training, etc.;
- Airway protection training, including Mendelsohn maneuver, supraglottic swallow training, etc.;
干预措施: Conventional Dysphagia Treatment (Behavioral)
sham tDCS group
Sham tDCS Treatment Protocol The electrode positions and treatment frequency of sham tDCS will be the same as those of real tDCS. The current is 0.05 mA. The treatment will be given once daily, 20 minutes per session, 5 times a week, for 2 consecutive weeks, totaling 10 sessions (5 sessions for each hemisphere).
Conventional Dysphagia Treatment
- Training for perioral muscles, tongue sensory and motor functions, including ice cotton swab stimulation, gustatory stimulation, tongue muscle movement training, etc.;
- Airway protection training, including Mendelsohn maneuver, supraglottic swallow training, etc.;
干预措施: sham tDCS (Device)
结局指标
主要结局
Rosenbek Penetration-Aspiration Scale (PAS):
时间窗: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up
Scored 1-8, with higher scores indicating poorer swallowing safety. 1. Level 1: The bolus does not enter the airway; it remains entirely within the oral cavity or pharynx and is propelled normally. 2. Level 2: The bolus enters the supraglottic area (e.g., vallecula) but does not touch the vocal cords, and is completely cleared (e.g., via swallowing or coughing). 3. Level 3: The bolus enters the supraglottic area without touching the vocal cords, but residue remains (not fully cleared). 4. Level 4: The bolus touches the vocal cords but does not enter the subglottic airway, and is completely cleared. 5. Level 5: The bolus touches the vocal cords without entering the subglottic airway, but residue remains. 6. Level 6: The bolus enters the subglottic airway (into the trachea) but is completely cleared by the patient (e.g., via coughing). 7. Level 7: The bolus enters the subglottic airway; the patient exhibits protective responses (e.g., coughing) but cannot fully clear it, leaving
Videofluoroscopic Dysphagia Scale (VDS)
时间窗: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up
14 items in total, including 7 items for oral-phase swallowing function and 7 for pharyngeal-phase function, used to assess overall swallowing function;
oral residue
时间窗: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up
Post-swallow residue was scored 0-3, with higher scores indicating more food residue and lower swallowing efficiency
Amplitude of Low Frequency Fluctuation (ALFF)
时间窗: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up
ALFF focuses on the low-frequency components of these HbO/HbR time series. It is defined as the average amplitude of hemodynamic signal fluctuations within a specific low-frequency range (typically 0.01-0.1 Hz, though the exact band may vary by study). This range is chosen because it captures slow, spontaneous oscillations in cerebral blood flow and oxygenation, which are hypothesized to reflect synchronized neural activity across brain regions (e.g., default mode network, sensorimotor networks). Mathematically, ALFF quantifies the "strength" of these low-frequency oscillations: a higher ALFF value indicates more prominent or intense fluctuations in the target frequency band, suggesting greater spontaneous hemodynamic (and thus neural) activity in that brain region.
Functional Connectivity (FC)
时间窗: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up
Functional Connectivity (FC) refers to the statistical association or synchronization between spontaneous hemodynamic signals from different cortical regions, reflecting the coordinated activity of spatially distinct brain areas. It quantifies how closely the neural activity (inferred from blood oxygenation changes) in one brain region correlates with that in another, providing insights into the integration of brain networks.
vellaculae residue
时间窗: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up
The residue amount was rated on a scale from 0 to 3: 0 indicates that no residue was visible, 1 indicates mild residue(the level of contrasted material constituted less than 25% of the height of the structure), 2 indicates moderate residue (the level of contrasted material constituted between 25 and 50%of the height of the structure), and 3 indicates severe residue(the level was higher than 50% of the height of the structure).
pyriform sinuses residue
时间窗: at baseline, after the completion of 10 days of intervention, at the 3-month follow-up
The residue amount was rated on a scale from 0 to 3: 0 indicates that no residue was visible, 1 indicates mild residue(the level of contrasted material constituted less than 25% of the height of the structure), 2 indicates moderate residue (the level of contrasted material constituted between 25 and 50%of the height of the structure), and 3 indicates severe residue(the level was higher than 50% of the height of the structure).
次要结局
- temporal indicators(at baseline, after the completion of 10 days of intervention, at the 3-month follow-up)
- spatial indicators(at baseline, after the completion of 10 days of intervention, at the 3-month follow-up)
- Swallowing Disorder Questionnaire (SDQ)(at baseline, after the completion of 10 days of intervention, at the 3-month follow-up)
- Functional Oral Intake Scale (FOIS)(at baseline, after the completion of 10 days of intervention, at the 3-month follow-up)
研究者
Wang Ping
senior therapist
Second Affiliated Hospital, School of Medicine, Zhejiang University