Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-29 @ 2:26 AM
Study NCT ID:
NCT06036368
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2023-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020329', 'term': 'Essential 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2023-08-18', 'studyFirstSubmitQcDate': '2023-09-06', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory efficacy', 'timeFrame': 'Baseline to end of treatment at 6 weeks', 'description': "The Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score (both total score and subscores) (applicable only for subjects with PD)(0-260, lower score = better)"}, {'measure': 'Exploratory efficacy', 'timeFrame': 'Baseline to end of treatment at 6 weeks', 'description': 'Essential tremor rating assessment scale (TETRAS) score (applicable only for subjects with ET, 0-64, lower scores = better))'}, {'measure': 'Exploratory efficacy', 'timeFrame': 'Baseline to end of treatment at 6 weeks', 'description': 'Bradykinesis and rigidity measured by Five Times Sit to Stand Test (FTSTS) (applicable only for subjects with PD, time in seconds, lower = better))'}, {'measure': 'Exploratory efficacy', 'timeFrame': 'Baseline to end of treatment at 6 weeks', 'description': 'Bradykinesis and rigidity measured objectively using the 10 meter Walking Speed Test (WST) (time in seconds, lower = better)(applicable only for subjects with PD)'}, {'measure': 'Exploratory efficacy', 'timeFrame': 'Baseline to end of treatment at 6 weeks', 'description': "Effect on patient's daily activities measured by Bain and Findley Activities of Daily Living (BF-ADL) (25-100, lower score = better)"}, {'measure': 'Exploratory efficacy', 'timeFrame': 'Baseline to end of treatment at 6 weeks', 'description': 'Degree of disability measured by modified Rankin Scale (mRS) (0-6, lower score= better)'}, {'measure': 'Exploratory efficacy', 'timeFrame': 'Baseline to end of treatment at 6 weeks', 'description': 'Quality of life measured by European Quality of Life-5 Dimensions questionnaire (EQ-5D-5L)(0.532-1.000, higher score = better)'}, {'measure': 'Exploratory efficacy', 'timeFrame': 'Baseline to end of treatment at 6 weeks', 'description': "Disease-specific quality of life measured by Parkinson's Disease Questionnaire (PDQ -39)(0-100, lower score = better)"}, {'measure': 'Exploratory efficacy', 'timeFrame': 'Baseline to end of treatment at 6 weeks', 'description': "Patient's satisfaction using Treatment Satisfaction Visual Analog scale (TS-VAS)(0-100, higher score = better)"}], 'primaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': 'Baseline to end of treatment at 6 weeks', 'description': 'Incidence of treatment emergent adverse events'}], 'secondaryOutcomes': [{'measure': 'Response of the condition on the therapy', 'timeFrame': 'Baseline to end of treatment at 6 weeks', 'description': 'Change in Patient Global Impression of Improvement scale (Scores 1-7, lower number = better)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease (PD) and Essential Tremor (ET)", 'Peroneal Electrical Transcutaneous NeuroModulation'], 'conditions': ["Parkinson's Disease", 'Essential Tremor']}, 'descriptionModule': {'briefSummary': "This is a 6-week exploratory clinical study, designed to test whether treatment with peroneal electrical trans-cutaneous stimulation can have a beneficial effects on symptoms associated with Parkinson's diseases and essential tremor.", 'detailedDescription': "This is a 6-week, open-label, single site clinical study designed to test whether treatment with peroneal electrical trans-cutaneous stimulation (eTNM) can have a beneficial effects on symptoms associated with Parkinson's diseases (PD) and essential tremor (ET). Eligible patients will be treated with eTNM at home for 6 weeks. Primary endpoint in this study is tolerability and safety, secondary and exploratory endpoints are various scale designed to capture improvements in the most bothersome symptoms of PD or ET."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age\n* Competent and willing to provide written, informed consent to participate in the study\n* Stable dose of any chronic medications, if applicable, for 30 days prior to study entry\n* Willing to comply with study protocol requirements\n* Subject agrees not to participate in another study from 30 days prior the screening visit until the final study visit\n* For subjects with PD:\n\nBradykinesia in "on" period based on clinical assessment Rigidity in "on" period based on clinical assessment Hand/arm exhibiting tremor (resting and/or intentional and/or postural) ≥ grade 1 as assessed by the MDS-UPDRS tremor score in "on" period\n\n• For subjects with ET: Visible hand/arm and/or foot/leg tremor (resting and/or intentional and/or postural) ≥ grade 1 as assessed by the TETRAS\n\nExclusion Criteria:\n\n* Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator\n* Suspected or diagnosed epilepsy or other seizure disorder\n* Severe degree of disability or dependence in daily activities \\>grade 3 as measured by modified Rankin Scale (mRS)\n* Presence of clinical signs or diagnosis of dementia\n* Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site\n* Presence of clinical signs of peripheral neuropathy on lower limbs\n* Presence of chorea and/or dyskinesia\n* Clinical symptoms or diagnosis of major depressive disorder\n* Presence of any other neurodegenerative disease. These may include multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer\'s disease.\n* Botulinum toxin injection within 6 months prior to study enrollment\n* Participation in another interventional clinical trial in the last 30 days, which may confound the results of this study, unless approved by the Sponsor\n* Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control (these are methods with a failure quotient of \\<1% year such as hormonal implants, injectable contraceptives, oral contraceptives of combination type, intra-uterine pessaries restricted to hormone contraceptive coil, sexual abstinence or vasectomy of the partner). The pregnancy test in urine at both Visits 1 and 2 needs to be negative in women of childbearing potential.\n* Subjects unable to communicate effectively with the investigator and staff\n* Life expectancy less than 6 months\n* Subject with active malignant disease\n* Subject with alcohol (more than 100 mg ethanol per day) or drug abuse during the recruitment and during the trial course\n* Subject who, in the opinion of the physician, may interfere with optimal participation in the clinical trial or may pose a risk to the subject\n* Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol'}, 'identificationModule': {'nctId': 'NCT06036368', 'briefTitle': "Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor", 'organization': {'class': 'INDUSTRY', 'fullName': 'Stimvia s.r.o.'}, 'officialTitle': "6-weeks, Open-label, Single-Site Study to Evaluate Safety, Tolerability and Efficacy of the Home-based Peroneal Electrical Transcutaneous NeuroModulation (Peroneal eTNM®) Treatment Via Nerve Stimulator URIS ITM in Treatment of Symptoms Related to Movement Disorders in Subjects With Parkinson's Disease (PD) and Essential Tremor (ET)", 'orgStudyIdInfo': {'id': 'TS004-PD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peroneal eTNM arm', 'description': 'All patients will receive treatment with peroneal eTNM', 'interventionNames': ['Device: Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)']}], 'interventions': [{'name': 'Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)', 'type': 'DEVICE', 'description': 'This is a non-invasive intervention, which utilizes direct trancutaneous, electrical stimulation of the peroneal nerve', 'armGroupLabels': ['Peroneal eTNM arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70200', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Cerebrovaskulární poradna s.r.o.', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}], 'overallOfficials': [{'name': 'David Skoloudik, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cerebrovaskulární poradna s.r.o., Ostrava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stimvia s.r.o.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}