Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 3:46 AM
Study NCT ID:
NCT07081568
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002544', 'term': 'Cerebral Infarction'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor function score', 'timeFrame': 'Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease', 'description': 'Motor function was evaluated using the Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) .The assessment was performed three times. The minimum score for the Fugl-Meyer Assessment (FMA) is 0, and the maximum score is 226.A higher score on the FMA indicates better motor recovery/function and a lower level of motor impairment.'}, {'measure': 'Overall functional score', 'timeFrame': 'Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease', 'description': 'Assess three times using the National Institutes of Health Stroke Scale. The maximum score on the scale is 42, and the minimum score is 0.Higher scores denote more severe stroke symptoms.'}, {'measure': 'Transcranial Magnetic Stimulation combined with Electroencephalography（TMS-EEG）', 'timeFrame': 'Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease', 'description': 'Amplitude and latency of key TMS-evoked potential (TEP) components ( N100, P180, N200) recorded from specific scalp electrodes (Fz, Cz, Pz) following single-pulse TMS over the dorsolateral prefrontal cortex (DLPFC).'}, {'measure': 'Sensory function score', 'timeFrame': 'Before the start of treatment, the last week before the end of treatment, and the third month after the onset of the disease', 'description': "Using the Eastern Michigan Neuropathy Symptom Score Assessment sensory scale for assessment, the lowest possible score is 0 and the highest is 100. A higher score indicates that the patient's neurological symptoms are more severe and that the degree of nerve damage is more apparent."}], 'secondaryOutcomes': [{'measure': 'Cognitive function score', 'timeFrame': 'Before the start of treatment', 'description': 'Using the Mini-Mental State Examination scale for assessment, the minimum score is 0 and the maximum score is 30. The higher the score, the better the cognitive function of the examinee, indicating a normal cognitive state.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemic Stroke', 'Transcutaneous Auriculai Vagus Nerve Stimulation', 'Rehabilitation for Cerebral Infarction', 'Neuromodulation'], 'conditions': ['Cerebral Infarction']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the efficacy and safety of binaural synchronous vagus nerve regulation in the treatment of patients with sensory and motor dysfunction after cerebral infarction through a randomized controlled clinical study, and to provide high-quality evidence support for binaural synchronous vagus nerve regulation in the treatment of cerebral infarction.', 'detailedDescription': 'The research subjects were first-onset cerebral infarction and were recruited at the Affiliated Rehabilitation Hospital of Nanchang University (the Fourth Affiliated Hospital). Based on the estimated sample size, a total of 40 patients were included in this study. The randomization grouping protocol divided 40 patients into the experimental group and the control group in a 1:1 ratio. Experimental group: Received synchronous vagus nerve regulation in both ears. Control group: Received false stimulation. The randomization procedure was carried out by independent statisticians who were not involved in the implementation and statistics of the study. The trial secretary placed the generated random numbers and groups respectively into opaque envelopes. After the patients were confirmed to be included in the group, the project leader opened the envelopes numbered in sequence to complete the grouping. This study was A double-blind design, using a unified binaural vagus nerve electrical stimulation device (JY-VNS-200, Jiangxi Jingyi Medical Technology Company Limited.). To achieve researcher blindness, the device was preset in A/B mode, with one mode being true stimulation and the other mode being false stimulation. After the experiment, unblinding was performed by personnel who were not involved in the study. During the experiment, the patients did not know whether they were receiving actual treatment or a placebo. The patients were blind. Meanwhile, the evaluators and statistical analysts were unaware of the grouping of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with first-episode ischemic stroke within 7 to 14 days of onset;\n* Be over 18 years old;\n* The skin at the irritated area remains intact;\n* The informed consent form has been signed.\n\nExclusion Criteria:\n\n* Severe cognitive dysfunction (Mini-Mental State Examination≥19);\n* Peripheral limb movement limiting factors (fractures);\n* History of major neurological and mental disorders in the past;\n* Uncontrollable limb and facial muscle twitching, and spontaneous profuse sweating;\n* Intracranial shunt pumps, metal implants'}, 'identificationModule': {'nctId': 'NCT07081568', 'briefTitle': 'Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Nanchang University Affiliated Rehabilitation Hospital'}, 'officialTitle': 'Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction', 'orgStudyIdInfo': {'id': 'SFYLL-KY-PJ-2025-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Sham Stimulation Group', 'description': 'Sham Stimulation Group received sham stimulation using device B, which had identical appearance, interface parameters, and physical sensation but no therapeutic effect. Stimulation parameters were set as follows: sinusoidal waveform; pulse width of 200μs; frequency of 20Hz; current adjusted to 0mA by the investigator; single session duration of 30 minutes. After each session, the device was disinfected with 75% alcohol. Treatment was administered once daily, 5 days per week, for a total duration of 4 weeks.'}, {'type': 'EXPERIMENTAL', 'label': 'transcutaneous auriculai vagus nerve stimulation', 'description': 'The patient was positioned in a supine position. Two stimulating electrodes were placed on the bilateral concha cymba and concha cavum. Stimulation parameters were set as follows: sinusoidal waveform; pulse width of 200μs; frequency of 20Hz; initial intensity of 2mA. Each treatment session lasted 30 minutes. Treatment was administered once daily, 5 days per week, for a total duration of 4 weeks. After each treatment session, the device was disinfected with 75% alcohol.', 'interventionNames': ['Device: transcutaneous auriculai vagus nerve stimulation']}], 'interventions': [{'name': 'transcutaneous auriculai vagus nerve stimulation', 'type': 'DEVICE', 'description': 'During bi-ear synchronous vagus nerve stimulation, the patient was positioned in a supine position. Two stimulating electrodes were placed bilaterally in the concha cymba and concha cavum of the ears. The patient received treatment for 30 minutes per session, once daily, 5 days per week, for a total of 4 weeks. Following each treatment session, the device was disinfected with 75% alcohol.', 'armGroupLabels': ['transcutaneous auriculai vagus nerve stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '330009', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Han Jinjing Attending Physician', 'role': 'CONTACT', 'email': '515476321@qq.com', 'phone': '13672202061'}], 'facility': 'The Fourth Affiliated Rehabilitation Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'centralContacts': [{'name': 'Han Jinjing Attending Physician', 'role': 'CONTACT', 'email': '515476321@qq.com', 'phone': '13672202061'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanchang University Affiliated Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of Medicine', 'investigatorFullName': 'Wentao Zeng', 'investigatorAffiliation': 'Nanchang University Affiliated Rehabilitation Hospital'}}}}