Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-01-01 @ 9:39 PM
Study NCT ID:
NCT07153692
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy and Mechanism of tDCS for Dysphagia in PD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-30', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-30', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Unified Parkinson's Disease Rating Scale-III (UPDRS-III)", 'timeFrame': 'at baseline, after the completion of 10 days of intervention, at the 3-month follow-up', 'description': '14 items, scored up to 56; higher scores indicate more severe motor dysfunction.'}, {'measure': 'Swallowing Quality of Life Questionnaire (SWAL-QOL)', 'timeFrame': 'at baseline, after the completion of 10 days of intervention, at the 3-month follow-up', 'description': 'The SWAL-QOL is a patient-reported outcome tool designed to assess the impact of oropharyngeal dysphagia on health-related quality of life. It Comprises 44 items. it evaluates both subjective experiences (e.g., psychological burden) and clinical symptoms (e.g., choking, food sticking) through self-reported responses.'}, {'measure': "Non-Motor Symptoms Scale (NMSS) for Parkinson's Disease", 'timeFrame': 'at baseline, after the completion of 10 days of intervention, at the 3-month follow-up', 'description': '30 items, scored up to 210; higher scores indicate more severe non-motor symptoms.'}], 'primaryOutcomes': [{'measure': 'Rosenbek Penetration-Aspiration Scale (PAS):', 'timeFrame': 'at baseline, after the completion of 10 days of intervention, at the 3-month follow-up', 'description': 'Scored 1-8, with higher scores indicating poorer swallowing safety.\n\n1. Level 1: The bolus does not enter the airway; it remains entirely within the oral cavity or pharynx and is propelled normally.\n2. 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).\n3. Level 3: The bolus enters the supraglottic area without touching the vocal cords, but residue remains (not fully cleared).\n4. Level 4: The bolus touches the vocal cords but does not enter the subglottic airway, and is completely cleared.\n5. Level 5: The bolus touches the vocal cords without entering the subglottic airway, but residue remains.\n6. Level 6: The bolus enters the subglottic airway (into the trachea) but is completely cleared by the patient (e.g., via coughing).\n7. Level 7: The bolus enters the subglottic airway; the patient exhibits protective responses (e.g., coughing) but cannot fully clear it, leaving'}, {'measure': 'Videofluoroscopic Dysphagia Scale (VDS)', 'timeFrame': 'at baseline, after the completion of 10 days of intervention, at the 3-month follow-up', 'description': '14 items in total, including 7 items for oral-phase swallowing function and 7 for pharyngeal-phase function, used to assess overall swallowing function;'}, {'measure': 'oral residue', 'timeFrame': 'at baseline, after the completion of 10 days of intervention, at the 3-month follow-up', 'description': 'Post-swallow residue was scored 0-3, with higher scores indicating more food residue and lower swallowing efficiency'}, {'measure': 'Amplitude of Low Frequency Fluctuation (ALFF)', 'timeFrame': 'at baseline, after the completion of 10 days of intervention, at the 3-month follow-up', 'description': '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).\n\nMathematically, 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.'}, {'measure': 'Functional Connectivity (FC)', 'timeFrame': 'at baseline, after the completion of 10 days of intervention, at the 3-month follow-up', 'description': '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.'}, {'measure': 'vellaculae residue', 'timeFrame': 'at baseline, after the completion of 10 days of intervention, at the 3-month follow-up', 'description': '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).'}, {'measure': 'pyriform sinuses residue', 'timeFrame': 'at baseline, after the completion of 10 days of intervention, at the 3-month follow-up', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'temporal indicators', 'timeFrame': 'at baseline, after the completion of 10 days of intervention, at the 3-month follow-up', 'description': 'TT, PTT, LVCrt, and so on.'}, {'measure': 'spatial indicators', 'timeFrame': 'at baseline, after the completion of 10 days of intervention, at the 3-month follow-up', 'description': 'hyoid bone advancement, hyoid bone elevation, PCR'}, {'measure': 'Swallowing Disorder Questionnaire (SDQ)', 'timeFrame': 'at baseline, after the completion of 10 days of intervention, at the 3-month follow-up', 'description': 'A swallowing function screening scale with 15 items, scored up to 44.5; higher scores indicate more severe dysphagia.'}, {'measure': 'Functional Oral Intake Scale (FOIS)', 'timeFrame': 'at baseline, after the completion of 10 days of intervention, at the 3-month follow-up', 'description': '7 levels in total, with Level 1 indicating the most severe feeding impairment and Level 7 indicating normal function.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Atypical Parkinsonian Syndromes', 'dysphagia', 'tDCS', 'VFSS'], 'conditions': ["Parkinson's Disease and Parkinsonism", 'Dysphagia']}, 'referencesModule': {'references': [{'pmid': '28699630', 'type': 'RESULT', 'citation': 'Ding X, Gao J, Xie C, Xiong B, Wu S, Cen Z, Lou Y, Lou D, Xie F, Luo W. Prevalence and clinical correlation of dysphagia in Parkinson disease: a study on Chinese patients. Eur J Clin Nutr. 2018 Jan;72(1):82-86. doi: 10.1038/ejcn.2017.100. Epub 2017 Jul 12.'}, {'pmid': '36115199', 'type': 'RESULT', 'citation': "Henry KA, Singh R, Zhang N, Lyons MK, McNett K, Neal MT, Mehta SH. Effect of STN/GPi DBS on swallowing function in Parkinson's disease as assessed by Video fluoroscopy: A retrospective study. Parkinsonism Relat Disord. 2022 Oct;103:136-140. doi: 10.1016/j.parkreldis.2022.08.017. Epub 2022 Sep 11."}, {'pmid': '34826007', 'type': 'RESULT', 'citation': "Wang P, Wang B, Chen X, Xiong B, Xie F, Wu S, Tang Y, Chen S, Ding X, Liu P, Luo W. Six-Year Follow-Up of Dysphagia in Patients with Parkinson's Disease. Dysphagia. 2022 Oct;37(5):1271-1278. doi: 10.1007/s00455-021-10387-0. Epub 2021 Nov 26."}, {'pmid': '34890260', 'type': 'RESULT', 'citation': 'Gandhi P, Steele CM. Effectiveness of Interventions for Dysphagia in Parkinson Disease: A Systematic Review. Am J Speech Lang Pathol. 2022 Jan 18;31(1):463-485. doi: 10.1044/2021_AJSLP-21-00145. Epub 2021 Dec 10.'}, {'pmid': '38487086', 'type': 'RESULT', 'citation': "Dashtelei AA, Nitsche MA, Salehinejad MA, Habibi AH, Bakhtyiari J, Khatoonabadi AR. Adjunctive transcranial direct current stimulation to improve swallowing functions in Parkinson's disease. EXCLI J. 2024 Jan 18;23:95-107. doi: 10.17179/excli2023-6496. eCollection 2024."}]}, 'descriptionModule': {'briefSummary': "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).\n\nAssessments 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.\n\nCorrelations between swallowing recovery and brain function changes, plus group imaging differences, will reveal tDCS's neurophysiological mechanism.", 'detailedDescription': '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.\n\nAll 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meet the Chinese Diagnostic Criteria for Parkinson's Disease (2016) or MDS Diagnostic Criteria for Multiple System Atrophy or Progressive Supranuclear Palsy;\n* VFSS examination indicates dysphagia;\n* Mini-Mental State Examination (MMSE) score \\>23;\n* Willing to cooperate with the study and sign the informed consent form;\n\nExclusion Criteria:\n\n* Comorbid with other diseases that cause dysphagia;\n* Comorbid with pneumonia, or severe cardiac/renal insufficiency;\n* Having metal implants in the body\n* With cognitive impairment or inability to cooperate."}, 'identificationModule': {'nctId': 'NCT07153692', 'briefTitle': 'Clinical Efficacy and Mechanism of tDCS for Dysphagia in PD', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': "Clinical Efficacy and Mechanism of tDCS for Dysphagia in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': '（2024）lunshenyan（1309）'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'real tDCS group', 'description': '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).\n\nConventional Dysphagia Treatment\n\n1. Training for perioral muscles, tongue sensory and motor functions, including ice cotton swab stimulation, gustatory stimulation, tongue muscle movement training, etc.;\n2. Airway protection training, including Mendelsohn maneuver, supraglottic swallow training, etc.;', 'interventionNames': ['Device: tDCS', 'Behavioral: Conventional Dysphagia Treatment']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham tDCS group', 'description': '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).\n\nConventional Dysphagia Treatment\n\n1. Training for perioral muscles, tongue sensory and motor functions, including ice cotton swab stimulation, gustatory stimulation, tongue muscle movement training, etc.;\n2. Airway protection training, including Mendelsohn maneuver, supraglottic swallow training, etc.;', 'interventionNames': ['Behavioral: Conventional Dysphagia Treatment', 'Device: sham tDCS']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'description': 'The IS200 intelligent electrical stimulator, manufactured in Chengdu, Sichuan, will be used. The electrode pads are 4cm × 6cm in size. The anode of the electrode pad will be placed on the swallowing sensorimotor cortex (S1/M1). The specific positioning will follow the international 10-20 electroencephalographic system: the left S1/M1 area is located at the midpoint of the line connecting C3 and T3 in the left hemisphere; the right S1/M1 area is located at the midpoint of the line connecting C4 and T4 in the right hemisphere. 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).', 'armGroupLabels': ['real tDCS group']}, {'name': 'Conventional Dysphagia Treatment', 'type': 'BEHAVIORAL', 'description': '1. Training for perioral muscles, tongue sensory and motor functions, including ice cotton swab stimulation, gustatory stimulation, tongue muscle movement training, etc.;\n2. Airway protection training, including Mendelsohn maneuver, supraglottic swallow training, etc.;', 'armGroupLabels': ['real tDCS group', 'sham tDCS group']}, {'name': 'sham tDCS', 'type': 'DEVICE', 'description': 'According to previous literature, the electrode positions and treatment frequency of sham tDCS will be the same as those of real tDCS. The current will be adjusted to 0.05mA.', 'armGroupLabels': ['sham tDCS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ping Wang, MS', 'role': 'CONTACT', 'email': '441350830@qq.com', 'phone': '15158113194'}, {'name': 'Bo Wang, MD', 'role': 'CONTACT', 'email': 'wangke1121@zju.edu.cn'}], 'facility': 'Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Ping Wang, MS', 'role': 'CONTACT', 'email': 'wangping6288@zju.edu.cn', 'phone': '15158113194'}, {'name': 'Bo Wang, MD', 'role': 'CONTACT', 'email': 'wangke1121@zju.edu.cn'}], 'overallOfficials': [{'name': 'Ping Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Zhejiang University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The IPD sharing plan includes making the statistical results of the data publicly available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wang Ping', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'senior therapist', 'investigatorFullName': 'Wang Ping', 'investigatorAffiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}}}}