Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT05456451
Status:
UNKNOWN
Last Update Posted:
2022-07-13
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D014202', 'term': 'Tremor'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'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': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The participants wit Parkinson disease, who has Hohen Yahr grade 2-3 will be included in the study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-10-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-11', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-11', 'lastUpdatePostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tremor', 'timeFrame': '1 day', 'description': "The tremor of the patients participating in the study will be evaluated with the smartphone application. After opening the phone application (G-Sensor), which is used to measure tremor, the patients will be asked to hold the phone in each hand at rest for 30 seconds and the tremor will be recorded. In this application, the maximum amplitude and frequency of the tremor in the 3D plane are calculated automatically. This application provides the opportunity to evaluate tremor numerically in patients with tremor, and there are studies where it has been used before in Parkinson's disease."}, {'measure': 'autonomic nervous system', 'timeFrame': '1 day', 'description': 'The effect of vagus nerve stimulation on autonomic nervous system activity is evaluated using heart rate variability by using Polar device.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vagus nerve stimulation', 'tremor', 'parkinson disease', 'upper extremity'], 'conditions': ['Parkinson Disease', 'Upper Extremity Dysfunction', 'Tremor']}, 'descriptionModule': {'briefSummary': "Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. The potential mechanisms of VSS in the improvement seen in PD are explained by increased cholinergic transmission, decreased neuroinflammation, and enhanced NE release.\n\nIn this study, it was aimed to investigate the effects of non-invasive vagus nerve stimulation to be applied to patients with Parkinson's disease on tremor and vagus nerve activity in patients.\n\nThe tremor and autonomic activations of the participants will be evaluated at pre and post treatment.", 'detailedDescription': 'Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. The potential mechanisms of VSS in the improvement seen in PD are explained by increased cholinergic transmission, decreased neuroinflammation, and enhanced NE release.\n\n5 patients who meet the inclusion criteria will be included in this prospectively planned study. As a vagus stimulation protocol, noninvasive auricular stimulation and stimulation frequency of 10 Hz, pulse width of 300 µs, biphasic application for 20 minutes will be applied to each patient 3 times on different days. Stimulations will be performed 3 times on 3 different days as the right ear, left ear and bilateral ear.\n\nThe tremor of the patients participating in the study will be evaluated with the smartphone application. After opening the phone application (G-Sensor), which is used to measure tremor, the patients will be asked to hold the phone in each hand at rest for 30 seconds and the tremor will be recorded. In this application, the maximum amplitude and frequency of the tremor in the 3D plane are calculated automatically.\n\nThe effect of vagus nerve stimulation on autonomic nervous system activity is evaluated using heart rate variability with Polar device.\n\nThe participants will be evaluated pre and post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being between the ages of 40-65.\n* Diagnosed with Parkinson's Disease by a specialist neurologist.\n* Hoehn-Yahr stage 2-3.\n* Having bilateral resting tremor of the hands.\n* Being agreed to participate in the study.\n\nExclusion Criteria:\n\n* Bilateral or unilateral previous injury to the vagus nerve (eg injury during carotid endarterectomy).\n* Severe depression (Beck Depression Scale \\> 29)\n* Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug.\n* Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from following the protocol timeline.\n* Pregnancy or planning to become pregnant or breast-feed during the study period.\n* Botox injections or any other upper extremity rehabilitation within 6 months prior to treatment."}, 'identificationModule': {'nctId': 'NCT05456451', 'briefTitle': "Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': "Investigation of the Effectiveness of Noninvasive Vagus Stimulation on Upper Extremity Functions in Parkinson's Disease", 'orgStudyIdInfo': {'id': '3616'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parkinson group(pre and post treatment)', 'description': '5 participants will be evaluated for tremor and autonomic dysfunction at pre and post treatment', 'interventionNames': ['Device: noninvasive vagus nerve srimulation']}], 'interventions': [{'name': 'noninvasive vagus nerve srimulation', 'type': 'DEVICE', 'description': "Non-invasive Vagus nerve stimulation (VNS) stimulates the vagus nerve through the ear via a headset. VNS is a non-pharmacological intervention with the potential to improve walking, cognition, fatigue, and autonomic functions in the treatment of Parkinson's disease.", 'armGroupLabels': ['Parkinson group(pre and post treatment)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34303', 'city': 'Istanbul', 'state': 'Kucukcekmece', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Merve Damla Korkmaz, M.D.', 'role': 'CONTACT', 'email': 'mervedml@gmail.com', 'phone': '+90(212) 404 15 00'}, {'name': 'A. Kivanc Menekseoglu, M.D.', 'role': 'CONTACT', 'email': 'kivancmenekseoglu@gmail.com'}], 'facility': 'Kanuni Sultan Suleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Merve Damla Korkmaz, M.D.', 'role': 'CONTACT', 'email': 'mervedml@gmail.com', 'phone': '+90(212) 404 15 00'}, {'name': 'A. Kivanc Menekseoglu, M.D.', 'role': 'CONTACT', 'email': 'kivancmenekseoglu@gmail.com', 'phone': '+90(212) 404 15 00'}], 'overallOfficials': [{'name': 'E. Efe Is, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}, {'name': 'Ceyhun Basoglu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Acibadem Atakent University Hospital'}, {'name': 'Mustafa Corum, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Physical Medicine and Rehabilitation Training and Research Hospital'}, {'name': 'Ali Veysel Ozden, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bahçeşehir University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'not decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sisli Hamidiye Etfal Training and Research Hospital', 'class': 'OTHER'}, {'name': 'Acibadem Atakent University Hospital', 'class': 'OTHER'}, {'name': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Merve Damla Korkmaz', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}