Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-21 @ 12:14 AM
Study NCT ID:
NCT04092556
Status:
UNKNOWN
Last Update Posted:
2019-09-17
First Post:
2019-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
tDCS for Multiple System Atrophy With Cerebellar Feature
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019578', 'term': 'Multiple System Atrophy'}, {'id': 'D002524', 'term': 'Cerebellar Ataxia'}], 'ancestors': [{'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001259', 'term': 'Ataxia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-16', 'studyFirstSubmitDate': '2019-09-08', 'studyFirstSubmitQcDate': '2019-09-16', 'lastUpdatePostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from International Cooperative Ataxia Rating Scale (ICARS)', 'timeFrame': 'per session: at baseline and within 30 minutes tDCS treatment completion', 'description': 'The scale is scored out of 100 with 19 items and 4 subscales of postural and gait disturbances, limb ataxia, dysarthria, and oculomotor disorders. Higher scores indicate higher levels of impairment.'}], 'secondaryOutcomes': [{'measure': 'Change from temporospatial parameters of gait', 'timeFrame': 'per session: at baseline and within 30 minutes tDCS treatment completion', 'description': 'Gait parameters measured by GAITRite system'}, {'measure': 'Change from posturography', 'timeFrame': 'per session: at baseline and within 30 minutes tDCS treatment completion', 'description': 'Posturography measured by Pedoscan system'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple System Atrophy', 'Cerebellar Ataxia', 'Transcranial Direct Current Stimulation'], 'conditions': ['Multiple System Atrophy, Cerebellar Variant (Disorder)']}, 'descriptionModule': {'briefSummary': 'The aim of study is to investigate most effective site for control the motor coordination using transcranial direct current stimulation in multiple system atrophy with cerebellar feature', 'detailedDescription': 'Participants receive transcranial direct current stimulation (tDCS) over M1, cerebellar cortex or sham stimulation for 30 minutes. The type of stimulation depends on random assignment. The participants have a 1 week of wash out period between each stimulation.\n\nThe assessment will be done by International Cooperative Ataxia Rating Scale (ICARS), GAITRITE (CIR Systems Inc., Clifton, New Jersey, USA) and PEDOSCAN (DIERS PEDO, Germany) at baseline and immediately after each treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Patients who meet the clinical criteria for probable multiple system atrophy with cerebellar features (MDS second consensus statement on the diagnosis of multiple system atrophy)\n* 2\\. Patients aged between 40 and 70\n* 3\\. Patients who do not have rigidity and bradykinesia\n* 4\\. Patients who have given voluntary consent after understanding the content of the clinical trial\n\nExclusion Criteria:\n\n* 1\\. Patients with a serious cognitive disorder, behavioral disorder, or mental illness\n* 2\\. Patients have history of seizure, stroke, encephalitis, other degenerative neurological disease\n* 3\\. Patients with a serious medical disease\n\n * Patients who concomitantly suffer from severe renal impairment, convulsions, stomach ulcers, moderate or more severe liver disease\n * Patients with un-controlled high blood pressure or diabetes\n* 4\\. Patients who have taken another investigational products within 4 weeks prior to being enrolled in this clinical trial, or patients who are pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04092556', 'briefTitle': 'tDCS for Multiple System Atrophy With Cerebellar Feature', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Exploratory Study to Evaluate the Effective Site for Control of Motor Coordination Function After Transcranial Direct Current Stimulation in Multiple Systemic Atrophy With Cerebellar Feature', 'orgStudyIdInfo': {'id': '2018-10-010-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tDCS (M1)', 'description': 'The participants will be submit to tDCS applied over the motor cortex (M1)', 'interventionNames': ['Device: transcranial direct current stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tDCS (Cerebellar cortex)', 'description': 'The participants will be submit to tDCS applied over the cerebellar cortex', 'interventionNames': ['Device: transcranial direct current stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham stimulation', 'description': 'The participants will be submit to sham stimulation', 'interventionNames': ['Device: transcranial direct current stimulation']}], 'interventions': [{'name': 'transcranial direct current stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': 'tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability.', 'armGroupLabels': ['Sham stimulation', 'tDCS (Cerebellar cortex)', 'tDCS (M1)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jinyoung Youn', 'role': 'CONTACT', 'email': 'genian@skku.edu', 'phone': '82-2-3410-0245'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jinyoung Youn', 'role': 'CONTACT', 'email': 'genian@skku.edu', 'phone': '82-2-3410-0245'}, {'name': 'Jong Hyeon Ahn', 'role': 'CONTACT', 'email': 'jonghyeon.ahn@samsung.com', 'phone': '82-2-3410-0245'}], 'overallOfficials': [{'name': 'Jinyoung Youn', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center, Department of Neurology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jinyoung Youn', 'investigatorAffiliation': 'Samsung Medical Center'}}}}