Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-31 @ 3:53 AM
Study NCT ID:
NCT06977269
Status:
RECRUITING
Last Update Posted:
2025-06-18
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Low Motoneuron Stimulation Via Transcranial Magnetic Stimulation in Spinal Muscular Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}], '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': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013129', 'term': 'Spinal Puncture'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-15', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-16', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in the Motor Function Measure Scale', 'timeFrame': 'The first assessment will be conducted before the initial TMS session, and the second will be performed one to two days after the final TMS session.', 'description': 'Motor Function Measure (MFM) scale measurement before and after TMS sessions'}, {'measure': 'Change from Baseline of the Revised Upper Limb Module', 'timeFrame': 'The first assessment will be conducted before the initial TMS session, and the second will be performed one to two days after the final TMS session.', 'description': 'Revised Upper Limb Module (RULM) scale measurement before and after TMS sessions'}, {'measure': 'Change from Baseline of the Hammersmith Functional Motor Scale - Expanded', 'timeFrame': 'The first assessment will be conducted before the initial TMS session, and the second will be performed one to two days after the final TMS session.', 'description': 'Hammersmith Functional Motor Scale - Expanded (HFMSE) measurement before and after TMS sessions'}, {'measure': 'Change from Baseline in the 6-Minute Walk Test', 'timeFrame': 'The first assessment will be conducted before the initial TMS session, and the second will be performed one to two days after the final TMS session.', 'description': '6-Minute Walk Test (6MWT) measurement before and after TMS sessions'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal muscular atrophy', 'Survival Motor Neuron protein (SMN)', 'Neurofilament (NF)', 'transcranial magnetic stimulation (TMS)'], 'conditions': ['Spinal Muscular Atrophy (SMA)']}, 'descriptionModule': {'briefSummary': 'There is a general physiological rule that any organ or system needs some minimal amount of activity to prevent its atrophy or degeneration. Although the relevance of that rule to exercises in neuromuscular patients and for SMA in particular is not definitely proven, clinical observations seem to support this assumption. Also there are several experimental studies which provide additional support for utility of exercise for SMA.\n\nHowever, making regular exercises may be very challenging with SMA not only due to physical limitations, but due to psychological either.\n\nWhile being considered as safe and well tolerated intervention, TMS is able to mimic effects of real physical exercises, at least at the level of low motoneuron, it also provides several advantages. For example, possibility to exercise non-collaborative infants, minimization of psychological motivation impact in adults and/or ability to involve very weak muscle groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has a diagnosis of 5q-autosomal recessive SMA confirmed by DNA test.\n* Informed consent.\n* A minimum score of 1 for Entry Item "A" of the Revised Upper Limb Module (RULM) scale for SMA: "Can use hands to hold pencil or pick up a coin/token or drive a powered chair, use phone key pad"\n\nExclusion Criteria:\n\n* Subject has severe joint contractures that would affect ability to perform study measures, determined by the study physician.\n* Subject has a deconditioned respiratory system, per the discretion of the physician investigator.\n* Subject has behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator.'}, 'identificationModule': {'nctId': 'NCT06977269', 'acronym': 'STIM-SMA', 'briefTitle': 'Safety and Tolerability of Low Motoneuron Stimulation Via Transcranial Magnetic Stimulation in Spinal Muscular Atrophy', 'organization': {'class': 'OTHER', 'fullName': 'Charitable Foundation Children with Spinal Muscular Atrophy'}, 'officialTitle': 'Safety and Tolerability of Low Motoneuron Stimulation Via Transcranial Magnetic Stimulation in Spinal Muscular Atrophy', 'orgStudyIdInfo': {'id': 'CSMA-INPN-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TMS arm', 'description': 'Stimulation (HF-rTMS) of the primary motor cortex, M1 area of the limbs, at a frequency above 5 Hz and an intensity of 90-100% of the resting motor threshold (RMT), over 10 sessions, up to 2400 stimuli per session.', 'interventionNames': ['Device: High-frequency repetitive transcranial magnetic stimulation', 'Diagnostic Test: lumbar puncture']}], 'interventions': [{'name': 'High-frequency repetitive transcranial magnetic stimulation', 'type': 'DEVICE', 'otherNames': ['HF-rTMS'], 'description': 'High-frequency repetitive transcranial magnetic stimulation targeting the primary motor cortex (M1) of the limbs, delivered at a frequency above 5 Hz and an intensity of 90-100% of the resting motor threshold, across 10 sessions with up to 2400 stimuli per session, is a standard intervention used in various neurological disorders. However, its effects have not been studied in patients with spinal muscular atrophy (SMA).', 'armGroupLabels': ['TMS arm']}, {'name': 'lumbar puncture', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cerebrospinal fluid sampling to measure SMN protein and neurofilament concentrations before and after the TMS intervention.', 'armGroupLabels': ['TMS arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61068', 'city': 'Kharkiv', 'state': 'Kharkivs’ka Oblast’', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Olena Pisotska Medical Director, MD, PhD', 'role': 'CONTACT', 'email': 'inpn@ukr.net', 'phone': '380577384194'}], 'facility': 'P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}], 'centralContacts': [{'name': 'Vitaliy M Matyushenko', 'role': 'CONTACT', 'email': 'csma.ua@gmail.com', 'phone': '380503640673'}, {'name': 'Andriy V Shatillo, MD, PhD', 'role': 'CONTACT', 'email': 'shatil@ukr.net', 'phone': '380978111884'}], 'overallOfficials': [{'name': 'Olena V Pisotska, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine'}, {'name': 'Andriy V Shatillo, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'only IPD used in the results publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charitable Foundation Children with Spinal Muscular Atrophy', 'class': 'OTHER'}, 'collaborators': [{'name': 'P.V. Voloshyn Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}