Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-01 @ 8:45 PM
Study NCT ID:
NCT06834269
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2025-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NfL reduction', 'timeFrame': '12 months', 'description': 'The potential reduction of NfL during treatment is monitored by blood samples collected at baseline, and then , every 3 months during the treatment'}], 'secondaryOutcomes': [{'measure': 'Monthly Progression Rate (MPR)', 'timeFrame': '15 months', 'description': 'MPR is derived from the 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 twelve months during the treatment. The ALSFRS-R is 12-items scale ranking from 0 (worse) to 48 (better) points.'}, {'measure': 'New Potential Theranostic Biomarkers Assay', 'timeFrame': '12 months', 'description': 'Investigation of potential theranostic biomarkers in blood samples (YKL-40, TDP43) and urine samples (p75ECD), collected at baseline and evrey three months during the treatment'}, {'measure': 'Effect on resting motor threshold (RMT) and active motor threshold (AMT)', 'timeFrame': '12 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': '12 months', 'description': 'Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amyothrophic Lateral Sclerosis', 'ALS', 'tSMS', 'transcranial magnetic stimulation', 'NF-L', 'YKL-40', 'p75ECD', 'Biomarkers', 'transcranial static magnetic stimulation', 'TDP43'], 'conditions': ['Amyotrophic Lateral Sclerosis (ALS)']}, 'descriptionModule': {'briefSummary': 'The objective of the present study is to assess the efficacy of tSMS in ALS patients. This will be achieved by monitoring:\n\n* levels of NF-L and other potential innovative biomarkers,\n* clinical progression, trough ALSFRS-R. After at least three-month follow-up, participants will be recruited to undergo biemispheric tSMS for two daily sessions of 120 minutes each, at home, for 12 months. Together with clinical status, which will be evalueted each three months, blood and urine samples will be collected before the start of the tSMS administration (M0) and during the treatment (M3, M6, M9, M12), to detect potential theranostic biomarkers. In a subgroup of patients, ad additional blood and urine sample will be collected 3 months before M0 (M-3).\n\nMoreover, cortical excitability will be tested through transcranial magnetic stimulation (TMS) before and after the tSMS stimulation period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18\n* diagnosis of possible, probable or definite 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 at the preliminary evaluation (M-3), assessed in the previous month (FVC ≥ 75% and ALSFRS-R items 10,11,12 \\> 4)\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* unable to perform spirometry due to severe bulbar involvement\n* contraindications to magnetic fields exposure\n* pregnancy or breastfeeding\n* history of epilepsy or seizures\n* use of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines.\n* cognitive impairment\n* lack of informed consent'}, 'identificationModule': {'nctId': 'NCT06834269', 'briefTitle': 'Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis.', 'organization': {'class': 'OTHER', 'fullName': 'Campus Bio-Medico University'}, 'officialTitle': 'Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis (ALS).', 'orgStudyIdInfo': {'id': 'StaticALS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pwALS', 'description': 'All participants will undergo tSMS administration at home, in two daily sessions of 120 minutes each.', 'interventionNames': ['Device: Transcranial magnetic stimulation (tSMS)']}], 'interventions': [{'name': 'Transcranial magnetic stimulation (tSMS)', 'type': 'DEVICE', 'description': 'Transcranial static magnetic stimulation (tSMS) will be delivered simultaneously to both hemispheres, at the motor cortex (M1), via magnets housed in a helmet.', 'armGroupLabels': ['pwALS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00128', 'city': 'Roma', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Di Lazzaro', 'role': 'CONTACT', 'email': 'v.dilazzaro@policlinicocampus.it', 'phone': '06 22541 1220'}], 'facility': 'Fondazione Policlinico Campus Bio-Medico', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Vincenzo Di Lazzaro', 'role': 'CONTACT', 'email': 'v.dilazzaro@policlinicocampus.it', 'phone': '06 22541 1220'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}