Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT04468932
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2020-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013494', 'term': 'Supranuclear Palsy, Progressive'}], 'ancestors': [{'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': 'D009886', 'term': 'Ophthalmoplegia'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The subjects will be blinded to the order of intervention, but the PI will not be blinded in order to perform the TMS intervention. The outcome evaluators will be blinded to the intervention, however.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The investigators will use a single-blind crossover design with a 4 week TMS washout period. The subjects will serve as their own controls, thus limiting confounding variables such as medication or cognitive effect.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-04-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'objective posturography', 'timeFrame': 'assessed on 4 days during the 8 week study period', 'description': 'The primary endpoint is center of pressure shifts with tilt and with translation, and body sway in quiet stance.'}], 'secondaryOutcomes': [{'measure': 'fNIRS', 'timeFrame': 'assessed on 4 days during the 8 week study period', 'description': 'functional near infrared spectroscopy of premotor and motor areas during balance testing'}, {'measure': 'speech analysis', 'timeFrame': 'assessed on 4 days during the 8 week study period', 'description': 'speech sample assessment conducted by investigator'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['repetitive transcranial magnetic stimulation'], 'conditions': ['Palsy Supranuclear', 'Supranuclear Palsy, Progressive']}, 'descriptionModule': {'briefSummary': 'The objective of this proposal is to investigate the effect of non-invasive repetitive cerebellar transcranial magnetic stimulation (rTMS) on motor control in progressive supranuclear (PSP). The central hypothesis is that augmenting cerebellar inhibition via cerebellar rTMS will decrease postural instability in patients with PSP. We will use functional near infrared spectroscopy (fNIRS) to examine changes in motor and premotor cortical activity after cerebellar rTMS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* probable or possible PSP by the revised MDS PSP Criteria (Hoglinger 2017)\n* age 40-85 at time of screening\n* ability to understand and cooperate with simple instructions in English\n* ability to read at 6th grade reading level in English\n* ability to stand unassisted for at least 30 seconds and to be able walk independently with a walker\n* ability to refrain from new physical and speech therapy programs for the duration of the study\n* ability to remain on stable doses of any cholinergic, dopaminergic, serotonergic sedative or NMDA receptor antagonists for the duration of the study\n* females of child-bearing age must perform a urine pregnancy test and be on reliable birth control during the course of the study\n\nExclusion Criteria:\n\n* other significant neurological or vestibular disorders\n* presence of electrically, magnetically or mechanically activated implants or history of injurious metal exposure in eyes, head, or body'}, 'identificationModule': {'nctId': 'NCT04468932', 'briefTitle': 'Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Cerebellar Transcranial Magnetic Stimulation for Motor Control in Progressive Supranuclear Palsy', 'orgStudyIdInfo': {'id': 'STUDY0020341'}, 'secondaryIdInfos': [{'id': 'KL2TR002370', 'link': 'https://reporter.nih.gov/quickSearch/KL2TR002370', 'type': 'NIH'}, {'id': 'P2CHD086844', 'link': 'https://reporter.nih.gov/quickSearch/P2CHD086844', 'type': 'NIH'}, {'id': 'K23NS121402', 'link': 'https://reporter.nih.gov/quickSearch/K23NS121402', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active TMS first', 'description': 'After completing their baseline assessment, participants randomized to this arm will initially take part in a 2-week TMS intervention. After the midpoint assessment and subsequent a 1-month washout, these participants will then complete a 2-week sham TMS period prior to their final assessment.', 'interventionNames': ['Device: Repetitive transcranial magnetic stimulation (rTMS)']}, {'type': 'EXPERIMENTAL', 'label': 'Sham treatment first', 'description': 'After completing their baseline assessment, participants randomized to this arm will initially take part in a 2-week sham TMS period. After the midpoint assessment and subsequent a 1-month washout, these participants will then complete a 2-week TMS intervention prior to their final assessment.', 'interventionNames': ['Device: Repetitive transcranial magnetic stimulation (rTMS)']}], 'interventions': [{'name': 'Repetitive transcranial magnetic stimulation (rTMS)', 'type': 'DEVICE', 'description': 'Aim 1: To determine the clinical effects of rTMS targeting the cerebellum on postural instability in PSP. The hypothesis to be tested is that TMS augmentation of cerebellar inhibition will improve cerebellum-dependent balance symptoms of PSP for a period of time sufficient to improve rehabilitation outcomes. The investigators will measure a battery of objective posturography metrics and other measures of motor control, including sway and center of pressure changes to backward tilt and forward translation.\n\nAim 2: We will use functional near infrared spectroscopy (fNIRS) to examine changes in motor and premotor cortical activity after cerebellar rTMS. The hypothesis to be tested is that premotor and motor cortical activity will decrease after cerebellar rTMS compared to sham TMS, reflecting improved cerebellar inhibition of the motor cortex after the intervention.', 'armGroupLabels': ['Active TMS first', 'Sham treatment first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Graham Harker', 'role': 'CONTACT', 'email': 'balance@ohsu.edu', 'phone': '5034182601'}], 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Graham Harker', 'role': 'CONTACT', 'email': 'balance@ohsu.edu', 'phone': '5034182601'}], 'overallOfficials': [{'name': 'Marian L Dale, MD, MCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center of Neuromodulation for Rehabilitation', 'class': 'OTHER'}, {'name': 'Collins Medical Trust', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Department of Health and Human Services', 'class': 'FED'}, {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}, {'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Neurology, School of Medicine; Director, OHSU CurePSP Center of Care', 'investigatorFullName': 'Marian L Dale, MD', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}