Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT06245967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-07
First Post:
2024-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Frequency Specific Microcurrent Therapy for Mild Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D051298', 'term': 'Post-Traumatic Headache'}, {'id': 'D004244', 'term': 'Dizziness'}, {'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-Concussion Symptom Scale (PCSS) scores', 'timeFrame': '1.5 month', 'description': 'The Post-Concussion Symptom Scale (PCSS) is used to assess the number and intensity of symptoms after a concussion/mild traumatic brain injury.'}], 'secondaryOutcomes': [{'measure': 'the amount of medication used for symptom management', 'timeFrame': '1.5 month', 'description': 'the amount of medication used for symptom management'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frequency specific microcurrent therapy', 'Concussion', 'Traumatic brain injury'], 'conditions': ['Trauma, Head', 'Headaches Posttraumatic', 'Dizziness', 'Brain Concussion', 'Frequency Specific Microcurrent Therapy']}, 'descriptionModule': {'briefSummary': 'Patients with mild traumatic brain injury (mTBI) may experience spontaneous recovery within 7-10 days, but some continue to exhibit symptoms such as headache, dizziness, vertigo, poor concentration, and cognitive dysfunction. Effective treatments for these symptoms are currently lacking. Frequency Specific Microcurrent(FSM) has received approval from the U.S. FDA for use in neuroinflammatory conditions. Our study aims to evaluate the efficacy of FSM by using FSM device ,IS02LCDs Stimulator (Ru Yi Health ltd. Co,Taiwan R.O.C), on symptom improvement in 52 patients with mild TBI', 'detailedDescription': 'This study is a single center double-blind randomized sham-controlled trail.We aims to recruit 52 mild traumatic brain injury participants with symptoms for more than 10 days.Clinical assessments include Post-Concussion Symptom Scale (PCSS) scores, and the amount of medication used for symptom management. These 52 participants will be 1:1 randomly allocated into two groups (1) sham FSM with symptom management medication and (2) True FSM with symptom management medication. The treatment period will last two weeks, with a total of six therapy sessions. Following treatment, a four-week observation period will be conducted. The primary outcome measurement will be changes in the Post-Concussion Symptom Scale (PCSS) scores, recorded at baseline, after the third treatment session, at the end of treatment, and at the end of the observation period. Secondary outcome measures will include the amount of medication used for symptom management. The safety evaluated index is the adverse event rate for two groups. These assessments aim to evaluate the therapeutic benefits of FSM for mild traumatic brain injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 20 and 65, inclusive, for both males and females.\n2. History of traumatic brain injury with a loss of consciousness lasting less than 30 minutes, initial Glasgow Coma Scale (GCS) score ranging from 13 to 15.\n3. Presence of persistent post-concussion symptoms starting from the day of injury and lasting for more than ten days.\n4. Complete consciousness or decision-making capacity at the time of enrollment.\n5. Brain imaging through CT or MRI indicating the absence of significant midline shift, no evident damage to the brainstem (excluding the pyramidal tract), or thalamus. Each brain lobe lesion should not exceed 30% of the respective cerebral hemisphere.\n\nExclusion Criteria:\n\n1. Individuals below 20 years or above 65 years of age, regardless of gender.\n2. History of traumatic brain injury with a loss of consciousness exceeding 30 minutes, initial Glasgow Coma Scale (GCS) score less than 13.\n3. Not a first-time occurrence of traumatic brain injury.\n4. Brain imaging through CT or MRI revealing significant midline shift, evident damage to the brainstem or thalamus, with each brain lobe lesion exceeding 30% of the respective cerebral hemisphere.\n5. Presence of comorbidities such as cancer, depression.'}, 'identificationModule': {'nctId': 'NCT06245967', 'briefTitle': 'Frequency Specific Microcurrent Therapy for Mild Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Frequency Specific Microcurrent Therapy for Mild Traumatic Brain injury-a Single Center Double-blind Randomized Sham-controlled Trail', 'orgStudyIdInfo': {'id': 'CMUH112-REC3-176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'True FSM (Concussion protocol) with symptom management medication', 'interventionNames': ['Device: Frequency specific microcurrent therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham-control', 'description': 'Sham FSM (no protocol) with symptom management medication', 'interventionNames': ['Device: Sham Frequency specific microcurrent therapy']}], 'interventions': [{'name': 'Frequency specific microcurrent therapy', 'type': 'DEVICE', 'description': 'Concussion protocol', 'armGroupLabels': ['Experimental']}, {'name': 'Sham Frequency specific microcurrent therapy', 'type': 'DEVICE', 'description': 'Shan concussion protocol', 'armGroupLabels': ['Sham-control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'I HAN Hsiao', 'role': 'CONTACT', 'email': 'coolfishing2002@gmail.com', 'phone': '+886933668642'}, {'name': 'CHEPIN CHANG', 'role': 'CONTACT', 'email': 'freedyrae@gmail.com', 'phone': '+886934073950'}], 'overallOfficials': [{'name': 'I HAN Hsiao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}