Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-02-25 @ 7:20 PM
Study NCT ID:
NCT02125032
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2014-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Low Voltage Pulsed Electromagnetic Fields (T-PEMF) in Patients With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2014-04-23', 'studyFirstSubmitQcDate': '2014-04-24', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Unified Parkinson´s Disease Rating Scale (UPDRS)', 'timeFrame': 'At baseline and at endpoint at week 8.', 'description': 'Comment on "Title": It is expected that the outcome measure UPDRS will report a change after 8 weeks of treatment compared to baseline.\n\nComment on "Time Frame": Data will be assessed at each group after 8 weeks, and will be presented when all included patients have received their intervention.'}]}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '30704504', 'type': 'DERIVED', 'citation': "Malling ASB, Morberg BM, Wermuth L, Gredal O, Bech P, Jensen BR. The effect of 8 weeks of treatment with transcranial pulsed electromagnetic fields on hand tremor and inter-hand coherence in persons with Parkinson's disease. J Neuroeng Rehabil. 2019 Jan 31;16(1):19. doi: 10.1186/s12984-019-0491-2."}, {'pmid': '29573167', 'type': 'DERIVED', 'citation': "Morberg BM, Malling AS, Jensen BR, Gredal O, Bech P, Wermuth L. Effects of transcranial pulsed electromagnetic field stimulation on quality of life in Parkinson's disease. Eur J Neurol. 2018 Jul;25(7):963-e74. doi: 10.1111/ene.13637. Epub 2018 Apr 17."}]}, 'descriptionModule': {'briefSummary': "The aim of this study, is to determine whether treatment using transcranial low voltage pulsed electromagnetic fields (T-PEMF) can reduce the symptoms patients with Parkinson's Disease (PD) experience. The symptoms include movement, mentality and the nervous system in general.\n\nFurthermore the purpose of this study is to clarify whether a group of patients with PD, gain a statistical improvement in their symptoms when treated with active T-PEMF, compared to a group of patients with PD who receive placebo T-PEMF ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Idiopathic Parkinson's disease H \\& Y 1-3 (Hoehn\\&Yahr)\n* MMSE \\> 22 (a screening test for dementia). (MMSE - Mini-Mental State Examination)\n* Age \\> 18 years.\n* The patient is capable understanding, accepting and complete the planned procedures.\n\nExclusion Criteria:\n\n* The patient has been using T-PEMF before.\n* Changes in anti-parkinson drug treatment within the last 6 weeks\n* Noticeable dementia or other brain injury, which may affect the ability to give consent, or complicates the assessment of the patient\n* Psychosis, or other psychopathological conditions, which requires intervention\n* The abuse of alcohol or drugs\n* Treatment with Deep Brain stimulation.\n* Pregnancy or nursing\n* Epilepsy.\n* Active implants such as pacemakers and others for example cochlear implants\n* Active medical device for example insulin pumps, baclofen pumps.\n* Participation in other trials in the intervention period\n* Current or previous history of brain tumors, leukemia, malignant melanoma, skin cancer, or head and neck cancer\n* Autoimmune disease\n* Wounds in the scalp"}, 'identificationModule': {'nctId': 'NCT02125032', 'briefTitle': "Transcranial Low Voltage Pulsed Electromagnetic Fields (T-PEMF) in Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'orgStudyIdInfo': {'id': 'T-PEMF14'}, 'secondaryIdInfos': [{'id': 'CIV-14-01-011780', 'type': 'OTHER', 'domain': 'Danish Health and Medicines Authority'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transcranial pulsed electromagnetic fields (T-PEMF)', 'description': 'One group receives 8 weeks of active T-PEMF treatment and another group receives 8 weeks of placebo T-PEMF. Both treatments to be performed 30 minutes once a day.', 'interventionNames': ['Device: Transcranial low voltage pulsed electromagnetic fields (T-PEMF)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Trancranial electromagnetic pulsed fields (T-PEMF)', 'description': '8 weeks of T-PEMF treatment placebo.', 'interventionNames': ['Device: Placebo Transcranial low voltage electromagnetic fields']}], 'interventions': [{'name': 'Transcranial low voltage pulsed electromagnetic fields (T-PEMF)', 'type': 'DEVICE', 'otherNames': ['The device name is: Re5 - Parkinson Treatment System'], 'armGroupLabels': ['Transcranial pulsed electromagnetic fields (T-PEMF)']}, {'name': 'Placebo Transcranial low voltage electromagnetic fields', 'type': 'DEVICE', 'otherNames': ['The devise name is: Re5 - Parkinson Treatment System'], 'armGroupLabels': ['Trancranial electromagnetic pulsed fields (T-PEMF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense C', 'state': 'Funen', 'country': 'Denmark', 'facility': 'OUH Odense University Hospital', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Ph.D. student', 'investigatorFullName': 'Bo Mohr Morberg', 'investigatorAffiliation': 'Odense University Hospital'}}}}