Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-01-04 @ 8:17 PM
Study NCT ID:
NCT05308667
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2022-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intermittent Theta Burst Stimulation in Addition to Constraint-Induced Movement Therapy in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-04', 'studyFirstSubmitDate': '2022-03-25', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment-Upper extremity', 'timeFrame': '30 minutes', 'description': 'The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and pain.'}, {'measure': 'Wolf-Motor Function Test', 'timeFrame': '45 minutes', 'description': 'It is a new time-based method to evaluate upper extremity performance while providing insight into joint-specific and total limb movements'}], 'secondaryOutcomes': [{'measure': 'Motor Evoked Potentials (MEPs)', 'timeFrame': '10 minutes', 'description': 'MEPs are the electrical signals recorded from the descending motor pathways or from muscles following stimulation of motor pathways within the brain.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Ischemic']}, 'referencesModule': {'references': [{'pmid': '38329642', 'type': 'DERIVED', 'citation': 'Kolbasi EN, Huseyinsinoglu BE, Ozdemir Z, Bayraktaroglu Z, Soysal A. Priming constraint-induced movement therapy with intermittent theta burst stimulation to enhance upper extremity recovery in patients with stroke: protocol for a randomized controlled study. Acta Neurol Belg. 2024 Jun;124(3):887-893. doi: 10.1007/s13760-024-02472-6. Epub 2024 Feb 8.'}]}, 'descriptionModule': {'briefSummary': 'In recent studies, it has been reported that intermittent theta-burst stimulation (iTBS) provides additional benefits when applied in adjunct to the rehabilitation in all stages of stroke (acute, subacute, or chronic). In our study, it was aimed to evaluate the effectiveness of iTBS applied in addition to modified constraint-induced movement therapy (mCIMT). By doing so, we intend to increase patient adherence to neurorehabilitation and decrease the cost of rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First time and unilateral stroke\n* 1-12 months after the incident\n* Getting 24 points or more in Mini Mental Status Examination\n* Being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary.\n* Being a low-functioning patient according to the CIMT criteria: a) At least 10 degrees of active wrist extension starting from the angle of full flexion, b) 10 degrees of extension at the metacarpophalangeal and inter-phalangeal joints of at least 2 fingers\n\nExclusion Criteria:\n\n* those who score more than 2.5 points on the Motor Activity Log-28 scale,\n* who have severe pain in the upper extremity (5 and above on the Visual Analogue Scale) and spasticity (3 and above on the Modified Ashworth Scale), which may affect the treatment, and\n* Those who do not have adequate communication skills.\n* Patients who have visual problems'}, 'identificationModule': {'nctId': 'NCT05308667', 'briefTitle': 'Effects of Intermittent Theta Burst Stimulation in Addition to Constraint-Induced Movement Therapy in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medeniyet University'}, 'officialTitle': 'Effects of Intermittent Theta Burst Stimulation in Addition to Constraint-Induced Movement Therapy in Stroke Patients', 'orgStudyIdInfo': {'id': 'IstanbulMU64'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iTBS + mCIMT group', 'interventionNames': ['Other: Rehabilitation (modified constraint-induced movement therapy)', 'Other: non-invasive brain stimulation (intermittent theta-burst stimulation)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham iTBS+ mCIMT group', 'interventionNames': ['Other: Rehabilitation (modified constraint-induced movement therapy)', 'Other: non-invasive brain stimulation (intermittent theta-burst stimulation)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mCIMT group', 'interventionNames': ['Other: Rehabilitation (modified constraint-induced movement therapy)']}], 'interventions': [{'name': 'Rehabilitation (modified constraint-induced movement therapy)', 'type': 'OTHER', 'description': 'Modified constraint-induced movement therapy (mCIMT): It is an intervention used to improve functionality and mobility in the more affected upper extremity post-stroke.', 'armGroupLabels': ['Sham iTBS+ mCIMT group', 'iTBS + mCIMT group', 'mCIMT group']}, {'name': 'non-invasive brain stimulation (intermittent theta-burst stimulation)', 'type': 'OTHER', 'description': 'Intermittent theta-burst stimulation (iTBS): It is a form of repetitive transcranial magnetic stimulation and it increases the facilitation of the motor cortex.', 'armGroupLabels': ['Sham iTBS+ mCIMT group', 'iTBS + mCIMT group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34394', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bakırköy Mazhar Osman Ruh ve Sinir Hastalıkları Hastanesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Marmara University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medeniyet University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Esma Nur KOLBAŞI', 'investigatorAffiliation': 'Istanbul Medeniyet University'}}}}