Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT05135533
Status:
COMPLETED
Last Update Posted:
2025-08-15
First Post:
2021-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuromodulation and Dynamic Balance in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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': 'D005684', 'term': 'Gait'}], 'ancestors': [{'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D016138', 'term': 'Walking'}, {'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2021-11-15', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gait speed', 'timeFrame': 'Pre-treatment, midpoint at four weeks, and post-treatment at 12 weeks', 'description': 'Self-selected comfortable walking overground walking speed.'}, {'measure': 'Change in balance', 'timeFrame': 'Pre-treatment, midpoint at four weeks, and post-treatment at at 12 weeks', 'description': 'Functional Gait Assessment (FGA) assesses stability during walking. The score ranges between 0 and 30 with lower scores indicative of poor dynamic balance.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Portable Neuromodulation Stimulator (PoNS) is non-invasive stimulation device placed on the tongue to stimulate those brain regions understood to be important for maintaining balance. This research study aims to collect evidence that PoNS therapy along with balance training improves postural and walking stability post-stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least six months since the onset of Ischemic or hemorrhagic stroke.\n* Demonstrate residual paresis in the lower extremity (Fugl-Mayer lower extremity score \\< 34).\n* Are able to provide informed consent demonstrated by their ability to weigh the consequences of participating versus not participating in the study.\n* Can walk at least 10 feet with and without assistive device.\n* Functional Gait Assessment score \\<22.\n\nExclusion Criteria:\n\n* Pre-existing neurological disorders.\n* Previous stroke affecting the other hemisphere .\n* Severe arthritis or orthopedic problems that limit passive range of motion.\n* Areas of recent bleeding or open wounds.\n* Lack normal sensation on the tongue.\n* Received treatment for cancer within the past year.\n* Non-removable metal orthodontic devices.\n* Oral health problems.\n* Are sensitive to nickel, gold or copper.\n* Chronic infectious diseases.\n* Are pregnant.\n* Have dementia'}, 'identificationModule': {'nctId': 'NCT05135533', 'briefTitle': 'Neuromodulation and Dynamic Balance in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Cranial-nerve Non-invasive Neuromodulation and Dynamic Balance in Chronic Stroke Survivors', 'orgStudyIdInfo': {'id': 'Pro00113565'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Portable Neuromodulation Stimulator', 'interventionNames': ['Device: Portable Neuromodulation Stimulation', 'Other: Gait and balance training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'interventionNames': ['Device: Sham', 'Other: Gait and balance training']}], 'interventions': [{'name': 'Portable Neuromodulation Stimulation', 'type': 'DEVICE', 'description': 'The PoNS group will receive electrical stimulation. Net direct current to the tongue electrode less than 1 µA (micro ampere) will be administered three times a week for four weeks in-lab setting, followed by three times a week for eight weeks at-home setting. Participants will continue to be enrolled in the study for additional 12 weeks without any intervention to evaluate long term effects.', 'armGroupLabels': ['Portable Neuromodulation Stimulator']}, {'name': 'Sham', 'type': 'DEVICE', 'description': 'The Sham group will not receive electrical stimulation.', 'armGroupLabels': ['Sham']}, {'name': 'Gait and balance training', 'type': 'OTHER', 'description': 'During each session participants will receive gait training exercises for 20 minutes, 20 minutes of balance training exercises, and 20 minutes of breathing exercise three times a week for four weeks in-lab setting. This will be followed by 20 minutes of gait training exercises, 20 minutes of balance training exercises, and 20 minutes of breathing exercise three times a week for eight weeks at-home setting. Participants will continue to be enrolled in the study for additional 12 weeks without any intervention to evaluate long term effects.', 'armGroupLabels': ['Portable Neuromodulation Stimulator', 'Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Steven Kautz, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'Immediately following publication no end date', 'ipdSharing': 'YES', 'description': 'All of the individual participant data that underlie the results reported in the article, after de-identification.', 'accessCriteria': 'anyone who wishes to access the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brooks Rehabilitation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Depertment Chair', 'investigatorFullName': 'Steven Kautz', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}