Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:04 AM
Study NCT ID:
NCT07306104
Status:
RECRUITING
Last Update Posted:
2025-12-29
First Post:
2025-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Long-term Daily Stimulation of the Brain With Pulsed Electromagnetic Fields on Parkinsons Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking only applies to the intervention groups. The control group and reference group are Open Label.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'EMG', 'timeFrame': 'From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.', 'description': 'Electromyographic recordings of forearm and thigh muscles during motor assessments (sit-to-stand, isometric contractions, postural tremor assessment, handwriting). Applied for explorative analyses, thus exact outcomes are not yet specified. However, agonist drive and co-contraction ratio may be assessed.'}, {'measure': 'Hand writing', 'timeFrame': 'From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.', 'description': 'Hand writing test performed with ink pen on paper on top of tablet (digitalizing handwriting). Performed as an explorative assessment.'}], 'primaryOutcomes': [{'measure': 'Sit-to-stand', 'timeFrame': 'From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.', 'description': 'Completion time of 5 repetition sit-tot-stand test at maximal speed performed on force plate.'}], 'secondaryOutcomes': [{'measure': 'Tremor intensity', 'timeFrame': 'From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.', 'description': 'Postural tremor intensity assessed by accelerometer'}, {'measure': 'Rate of force development', 'timeFrame': 'From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.', 'description': 'Isometric rate of force development assessed by handgrip and knee extension'}, {'measure': "Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)", 'timeFrame': 'From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.', 'description': 'The MDS-UPDRS will be reported as total score (0-260, higher scores indicate greater disease severity) and motor score (part III, 0-132, higher scores indicate greater disease severity).'}, {'measure': 'Cerebrospinal fluid biomarkers', 'timeFrame': 'From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. Assessment in the intervention groups only.', 'description': 'Concentration of growth factors, cytokines and cytoskeletal proteins with special emphasis on erythropoietin (EPO), vascular endothelial growth factor (VEGF), brain-derived neutrophic factor (BDNF), glia cell derived neutrophilic factor (GDNF), Glucagon Like Peptide 1 (GLP1), interleukins and neurofilament light chain (NfL).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['T-PEMF'], 'conditions': ['PARKINSON DISEASE (Disorder)']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn to what extent daily stimulation of the brain with transcranial pulsed electromagnetic fields (T-PEMF) works to treat persons with Parkinson\'s Disease. The main questions it aims to answer are:\n\n* How does 6 months of daily treatment (30 minutes/day) with T-PEMF affects neuro-mechanical and molecular biological factors compared with placebo treatment in persons with Parkinson\'s disease?\n* How does 12 months of daily treatment (30 minutes/day) with T-PEMF affects neuro-mechanical and molecular biological factors in persons with Parkinson\'s disease an does 12 months of T-PEMF alters the need for medication intake?\n\nThe neuro-mechanical outcomes are compared with the "natural" progression of the disease as well as with a healthy reference group. Furthermore, it will be examined whether 12 months of T-PEMF treatment alters the need for medication intake.\n\nParticipants in the intervention group will:\n\n* receive one 30 min treatment session daily for 12 months\n* receive either T-PEMF or sham treatment for the first 6 months\n* receive active T-PEMF treatment the last 6 months\n* visit for tests before treatment initiation, after 6 months of treatment and after 12 months of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Intervention Groups\n\nInclusion Criteria:\n\n* Diagnosed with idiopathic Parkinson's disease\n* The participant must be able to understand, accept, and complete the planned procedures\n* Parkinson's symptoms in the medicated state must correspond to Hoehn \\& Yahr stage 1 or 2\n* Mini Mental-State Examination score \\> 22\n\nExclusion Criteria:\n\n* Cancer in the brain, neck, or head area\n* Presence of active medical implants\n* Epilepsy\n* Alcoholism\n* Substance abuse\n* Open wound on the scalp\n* Severe psychopathological disorders\n* Pregnancy\n* Changes in pharmacological anti-Parkinson medication within the last 6 weeks prior to the start of T-PEMF treatment\n* Anticoagulant treatment with Marevan, Marcoumar, Pradaxa, Eliquis, Xarelto, Lixiana, Novostan, Fragmin, or Innohep\n* Neurological disease other than Parkinson's disease\n* Previous stroke\n* Reduced motor function caused by conditions other than Parkinson's disease\n\nControl Group with Parkinson's Disease\n\nInclusion Criteria:\n\n* Diagnosed with idiopathic Parkinson's disease\n* The patient must be able to understand, accept, and complete the planned procedures\n* Parkinson's symptoms in the medicated state must correspond to Hoehn \\& Yahr stage 1 or 2\n* Mini Mental-State Examination score \\> 22\n\nExclusion Criteria:\n\n* Neurological disease other than Parkinson's disease\n* Reduced motor function caused by conditions other than Parkinson's disease\n\nHealthy Reference Group:\n\nInclusion Criteria:\n\n-The patient must be able to understand, accept, and complete the planned procedures\n\nExclusion Criteria:\n\n* Neurological disease\n* Reduced motor function caused by condition"}, 'identificationModule': {'nctId': 'NCT07306104', 'briefTitle': 'The Effect of Long-term Daily Stimulation of the Brain With Pulsed Electromagnetic Fields on Parkinsons Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': "The Effect of Long-term Treatment of Parkinson's Disease With T-PEMF", 'orgStudyIdInfo': {'id': 'SDURio #12.562'}, 'secondaryIdInfos': [{'id': '2501906', 'type': 'OTHER', 'domain': 'The Danish Medical Research Ethics Committees'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group 1: Full T-PEMF', 'description': "Persons with Parkinson's disease receiving 30 min daily active T-PEMF for 12 months. The first 6 months are blinded, the last 6 months are not.", 'interventionNames': ['Device: Transcranial pulsed electromagnetic fields (T-PEMF)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Intervention group 2: sham + T-PEMF', 'description': "Persons with Parkinson's disease receiving 30 min daily sham T-PEMF for 6 months followed by 6 moths of 30 min daily active T-PEMF. The first 6 month is blinded, the last 6 months are not.", 'interventionNames': ['Device: Transcranial pulsed electromagnetic fields (T-PEMF)', 'Device: Sham (No Treatment)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "Persons with Parkinson's disease receiving no experimental treatment. The group is used to monitor natural course of the disease."}, {'type': 'NO_INTERVENTION', 'label': 'Healthy reference group', 'description': 'Health age-matched persons assessed once to obtain age-matched normal intervals of performance.'}], 'interventions': [{'name': 'Transcranial pulsed electromagnetic fields (T-PEMF)', 'type': 'DEVICE', 'description': '30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)', 'armGroupLabels': ['Intervention group 1: Full T-PEMF', 'Intervention group 2: sham + T-PEMF']}, {'name': 'Sham (No Treatment)', 'type': 'DEVICE', 'description': '30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs', 'armGroupLabels': ['Intervention group 2: sham + T-PEMF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Christian Winterberg, MD', 'role': 'CONTACT', 'email': 'christian.winterberg@rsyd.dk', 'phone': '+45 65411833'}, {'name': 'Christian Winterberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '5230', 'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Anne Sofie Bøgh Malling, Ph.d.', 'role': 'CONTACT', 'email': 'amalling@health.sdu.dk', 'phone': '+45 28903733'}, {'name': 'Jens Bojsen-Møller, Ass. proffessor', 'role': 'CONTACT', 'email': 'jbojsen@health.sdu.dk'}, {'name': 'Anne Sofie B Malling, Ph.d.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mikkel C Juhl, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Morten Meyer, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bente R Jensen, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jens Bojsen-Møller, Ass. Professor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Anne Sofie Bøgh Malling, Ph.d.', 'role': 'CONTACT', 'email': 'amalling@health.sdu.dk', 'phone': '+45 28903733'}, {'name': 'Bente Rona Jensen, Professor', 'role': 'CONTACT', 'email': 'brjensen@health.sdu.dk'}], 'overallOfficials': [{'name': 'Anne Sofie Bøgh Malling, Ph.d.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Bente & Erik Schøller Larsens Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}