Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-23 @ 3:02 PM
Study NCT ID:
NCT04393467
Status:
UNKNOWN
Last Update Posted:
2020-10-19
First Post:
2020-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-14', 'studyFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2020-05-16', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease progression', 'timeFrame': '9 months', 'description': 'Comparison between the ALSFRS-R (Revised Amyotrophic Lateral Sclerosis Functional Rating Scale) decline over the period of at least three months before the treatment and the period of six months during the treatment. The ALSFRS-R is 12-items scale ranking from 0 (worse) to 48 (better) points.'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': '6 months', 'description': 'Incidence of adverse events during the stimulation period'}, {'measure': 'Compliance', 'timeFrame': '6 months', 'description': 'Number of stimulation sessions actually completed by each patient'}, {'measure': 'Effect on resting motor threshold (RMT) and active motor threshold (AMT)', 'timeFrame': '6 months', 'description': 'Change in TMS-derived cortical excitability parameters (RMT and AMT) before and after stimulation period.'}, {'measure': 'Effect on motor evoked potentials (MEP) size', 'timeFrame': '6 months', 'description': 'Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amyotrophic Lateral Sclerosis', 'ALS', 'transcranial magnetic stimulation', 'static magnetic field', 'tSMS'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'referencesModule': {'references': [{'pmid': '39185360', 'type': 'DERIVED', 'citation': 'Di Lazzaro V, Ranieri F, Doretti A, Boscarino M, Maderna L, Colombo E, Soranna D, Zambon A, Ticozzi N, Musumeci G, Capone F, Silani V. Transcranial static magnetic stimulation for amyotrophic lateral sclerosis: a bicentric, randomised, double-blind placebo-controlled phase 2 trial. Lancet Reg Health Eur. 2024 Jul 30;45:101019. doi: 10.1016/j.lanepe.2024.101019. eCollection 2024 Oct.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate safety and efficacy of tSMS in ALS patients and to obtain preliminary data about the effects of tSMS on cortical excitability.\n\nTo this purpose, 40 ALS patients will be recruited and randomized to real or sham tSMS. After at least 3 months follow-up, they will undergo tSMS, daily for 120 min, at home, for 6 consecutive months.\n\nClinical status will be tested before, during and after the stimulation period. Moreover, cortical excitability will be tested by transcranial magnetic stimulation (TMS) before and after the stimulation period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 75 years\n* diagnosis of ALS according to revised El Escorial criteria and Awaji-Shima criteria\n* disease duration \\< 24 months\n* ALSFRS-R \\> 30 at the recruitment\n* ALSFRS-R decline \\> 1 in the at least 3-months period before the intervention\n* normal respiratory functionality (FVC \\> 80% and ALSFRS-R items 10,11,12 \\> 4) at the recruitment\n* treatment with riluzole 50 mg x 2/die\n\nExclusion Criteria:\n\n* inclusion in other clinical trials\n* presence of tracheotomy or/and PEG (percutaneous endoscopic gastrostomy)\n* contraindications to magnetic fields exposure\n* pregnancy or breast-feeding\n* history of epilepsy or seizures\n* assumption of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines.\n* cognitive impairment\n* lack of informed consent'}, 'identificationModule': {'nctId': 'NCT04393467', 'briefTitle': 'Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).', 'organization': {'class': 'OTHER', 'fullName': 'Campus Bio-Medico University'}, 'officialTitle': 'Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).', 'orgStudyIdInfo': {'id': 'STIMALS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'real tSMS', 'description': 'tSMS will be delivered by a magnet applied to M1, bilaterally (120 min daily, for 6 months). Magnet will be kept in position by a plastic helmet.', 'interventionNames': ['Device: tSMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham tSMS', 'description': 'A non-magnetic steel cylinder, with same size, weight and appearance of the magnet, will be used for sham stimulation.', 'interventionNames': ['Device: sham tSMS']}], 'interventions': [{'name': 'tSMS', 'type': 'DEVICE', 'description': 'tSMS delivered on bilateral motor cortex', 'armGroupLabels': ['real tSMS']}, {'name': 'sham tSMS', 'type': 'DEVICE', 'description': 'sham tSMS delivered on bilateral motor cortex by a non-magnetic steel cylinder, with same size, weight and appearance of the magnet used for real tSMS', 'armGroupLabels': ['sham tSMS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Silani, MD', 'role': 'CONTACT', 'email': 'vincenzo.silani@unimi.it', 'phone': '+39 02619111'}], 'facility': 'Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '00128', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Di Lazzaro, MD', 'role': 'CONTACT', 'email': 'v.dilazzaro@unicampus.it', 'phone': '+39 06 22541 1320'}, {'name': 'Fioravante Capone, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marilisa Boscarino, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Neurology Unit, Campus Biomedico University', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Campus Bio-Medico University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor of Neurology', 'investigatorFullName': 'Di Lazzaro Vincenzo', 'investigatorAffiliation': 'Campus Bio-Medico University'}}}}