Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT04010994
Status:
UNKNOWN
Last Update Posted:
2019-10-03
First Post:
2019-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-02', 'studyFirstSubmitDate': '2019-07-03', 'studyFirstSubmitQcDate': '2019-07-04', 'lastUpdatePostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual field size', 'timeFrame': '3 months', 'description': 'Static perimetry and high resolution perimetry will be used to measure the visual field sizes'}], 'secondaryOutcomes': [{'measure': 'EEG connectivities in the visual system', 'timeFrame': '3 months', 'description': 'EEG recordings will be done using 128 channels, power spectra will be determined'}, {'measure': 'Level of vascular regulation/dysregulation in the eye', 'timeFrame': '3 months', 'description': 'Dynamic vessel analysis will be used the measure blood flow in the eye'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma', 'Electrical Stimulation', 'Home Treatment']}, 'referencesModule': {'references': [{'pmid': '27355577', 'type': 'BACKGROUND', 'citation': 'Gall C, Schmidt S, Schittkowski MP, Antal A, Ambrus GG, Paulus W, Dannhauer M, Michalik R, Mante A, Bola M, Lux A, Kropf S, Brandt SA, Sabel BA. Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial. PLoS One. 2016 Jun 29;11(6):e0156134. doi: 10.1371/journal.pone.0156134. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to investigate the possibilities of visual field enhancement with electrical stimulation (ES) as a home stimulation method, in a total of 50 patients with optical neuropathy, who have already been treated with ES in the past.\n\nFurthermore, factors responsible for response variability and treatment effectiveness are also explored: (i) the role of mental stress (or stress resilience), (ii) the status of biomarkers, such as the systemic stress hormone levels and blood supply to the eye and brain (specifically vascular dysregulation) and (iii) the influence of personality, anxiety, depression and lifestyle. The study serves to further validate this ES procedure for the treatment of visual impairment. Specifically, better efficacy, better compliance, lowest response variability are expected after long-term home use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with glaucoma, disease duration at least 6 months\n* stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded)\n* presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician\n* best corrected visual acuity at least 0.4 (20/50 Snellen) or better\n\nExclusion Criteria:\n\n* autoimmune diseases in the acute stage\n* neurological and mental diseases\n* diabetic retinopathy\n* addictions\n* hypertension (maximum 160/100 mmHg)\n* retinitis pigmentosa-\n* pathological nystagmus\n* non-distant tumors or recurrent tumors\n* photosensitivity\n* pregnancy\n* electric or electronic implants (e.g. heart pacemaker)\n* metal implants in the eyes or head (with the exception of dental prosthesis or shunts)'}, 'identificationModule': {'nctId': 'NCT04010994', 'acronym': 'HomeStim', 'briefTitle': 'Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Magdeburg'}, 'officialTitle': 'Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study', 'orgStudyIdInfo': {'id': 'StimulationMagd'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'rtACS', 'description': 'repetitive transorbital ACS', 'interventionNames': ['Procedure: Transorbital electrical stimulation']}], 'interventions': [{'name': 'Transorbital electrical stimulation', 'type': 'PROCEDURE', 'description': 'Transorbital ACS using 8-12 Hz with 0,5-1,5 mA Intensity, during the first two weeks 1/day, after 2/week for 10 weeks, as a home treatment', 'armGroupLabels': ['rtACS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Institute of Medical Psychology', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'After publication', 'ipdSharing': 'YES', 'description': 'Data will be available without restriction', 'accessCriteria': 'Contact to the Principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Magdeburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Institute, Professor', 'investigatorFullName': 'Bernhard A. Sabel', 'investigatorAffiliation': 'University of Magdeburg'}}}}