Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT04750551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-24
First Post:
2021-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment (Pilot).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2021-02-10', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)', 'timeFrame': 'Baseline, 5 minutes after intervention', 'description': 'MAS will be performed to check changes of finger flexor spasticity after one session of treatment.\n\nThe Modified Ashworth scale (MAS) scoring is categorical and ranges from 0 to 4, as follows:\n\n0: No increase in muscle tone\n\n1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion (ROM)\n2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved\n3. Considerable increase in muscle tone, passive movement difficult\n4. Affected part(s) rigid in flexion or extension'}], 'secondaryOutcomes': [{'measure': 'Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale', 'timeFrame': 'Baseline, 5 minutes after intervention', 'description': 'FMA will be assessed to test function changes of finger extensors and hand function after one session of treatment.\n\nThe upper limb motor function domain of the FMA scale will be used, and the score range for this domain is 0 to 66, with a higher score indicating better function.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Finger flexor spasticity', 'Motor Recovery', 'BreEStim'], 'conditions': ['Motor Recovery']}, 'descriptionModule': {'briefSummary': 'The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with moderate impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* has post stroke ≥ 6 months , medically stable;\n* Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);\n* MAS score ≥ 1, i.e., detectable finger flexor hypertonia;\n\nExclusion criteria include:\n\n* Patients with visual deficit/neglect; hearing or cognitive impairment;\n* Patients with history of pulmonary disease (Asthma, chronic obstruction pulmonary disease, COPD);\n* Patients that are currently adjusting tone alternating medications (e.g., baclofen), or\n* Patients received botulinum toxin injection to the arm/fingers \\<4 months, or phenol injections \\< 2 years;\n* Patients with a pacemaker;\n* Women who are pregnant.'}, 'identificationModule': {'nctId': 'NCT04750551', 'briefTitle': 'BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment (Pilot).', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'BreEStim for Post-Stroke Motor Recovery', 'orgStudyIdInfo': {'id': 'HSC-MS-20-1286 (Experiment 1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BreEStim', 'description': 'BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.', 'interventionNames': ['Device: BreEStim']}, {'type': 'EXPERIMENTAL', 'label': 'EStim', 'description': 'EStim is transcutaneous electrical nerve stimulation.', 'interventionNames': ['Device: EStim']}], 'interventions': [{'name': 'BreEStim', 'type': 'DEVICE', 'description': 'BreEStim will applied for 10 to 20 minutes.', 'armGroupLabels': ['BreEStim']}, {'name': 'EStim', 'type': 'DEVICE', 'description': 'EStim will applied for 10 to 20 minutes.', 'armGroupLabels': ['EStim']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Sheng Li, MD, PhD', 'role': 'CONTACT', 'email': 'sheng.li@uth.tmc.edu', 'phone': '713-500-5874'}, {'name': 'Shengai Li, MS', 'role': 'CONTACT', 'email': 'shengai.li@uth.tmc.edu', 'phone': '713-797-7561'}], 'facility': 'The University of Texas Health Science Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Sheng Li, MD, PhD', 'role': 'CONTACT', 'email': 'sheng.li@uth.tmc.edu', 'phone': '(713) 797-7125'}, {'name': 'Shengai Li, MS', 'role': 'CONTACT', 'email': 'shengai.li@uth.tmc.edu', 'phone': '713-797-7561'}], 'overallOfficials': [{'name': 'Sheng Li, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sheng Li', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}