Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 6:57 PM
Study NCT ID:
NCT05256160
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2022-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cortical Excitability in Cyclic Vomiting Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536228', 'term': 'Familial cyclic vomiting syndrome'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a comparative study looking at differences in electrophysiologic measures of cortical excitability between those with Cyclic Vomiting Syndrome and healthy controls.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2022-02-15', 'studyFirstSubmitQcDate': '2022-02-15', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Paired-pulse ratios', 'timeFrame': 'Multiple study sessions spanning up to 12 months', 'description': 'Percentage Change in Paired Pulse (PP) TMS induced MEP responses with inhibitory or facilitatory stimulation.'}], 'secondaryOutcomes': [{'measure': 'TMS motor threshold', 'timeFrame': 'Multiple study sessions spanning up to 12 months', 'description': 'TMS stimulator output necessary to elicit 200 microvolt MEP responses'}, {'measure': 'Cortical silent period', 'timeFrame': 'Multiple study sessions spanning up to 12 months', 'description': 'Length (milliseconds) of EMG inactivity following TMS stimulation'}, {'measure': 'Heart rate variability', 'timeFrame': 'Multiple study sessions spanning up to 12 months', 'description': 'Spectral frequency analysis (via Fast Fourier Transformation) of R-R intervals'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cyclic Vomiting Syndrome']}, 'descriptionModule': {'briefSummary': 'This exploratory study will determine if there are differences in cortical excitability between patients suffering from cyclic vomiting syndrome (CVS) and healthy control subjects, as assessed by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS).', 'detailedDescription': 'This exploratory study will determine if there are differences in cortical excitability between patients suffering from cyclic vomiting syndrome (CVS) and healthy control subjects, as assessed by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS).\n\nUsing the paired-pulse TMS paradigm, intracortical inhibition and facilitation of cortical circuitry will be assessed by stimulating the motor cortex and using the electromyographic (EMG) response of a target muscle as readout. In such studies, a conditioning stimulus modulates the amplitude of the motor-evoked potential (MEP) produced by the test stimulus. Depending on the inter-stimulus interval, effects can be attributed to different aspects of cortical processing. Brief intervals (1-5 ms) will be used to assess short-interval intracortical inhibition (SICI) and short-interval intracortical facilitation (SICF), intermediate intervals (7-20 ms) to assess intracortical facilitation (ICF) and long intervals (50-200 ms) to assess long-interval intracortical inhibition (LICI).\n\nSome clinical, demographic, and autonomic data (i.e. EKG) will be recorded and used as covariates to investigate any systematic impact on cortical excitability measures collected with the paired-pulse protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of CVS\n\nExclusion Criteria:\n\n* history of CVS (for healthy control population only)\n* psychosis or altered cognitive status\n* history of head injury, metal in the skull, stroke, or a history of seizures or a history of syncope (fainting or passing out)\n* implantable devices, such as a pacemaker or nerve stimulator\n* current use of the following medications or use of substances which are known to lower the seizure threshold: clozapine (Clozaril), chlorpromazine (Thorazine), amphetamines or methamphetamine, Ecstasy, Ketamine, Angel Dust/PCP, cocaine, or 3 or more alcoholic drinks per day\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT05256160', 'briefTitle': 'Cortical Excitability in Cyclic Vomiting Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Cortical Excitability in Cyclic Vomiting Syndrome', 'orgStudyIdInfo': {'id': 'STUDY21120001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CVS subjects', 'description': 'Subjects diagnosed with Cyclic Vomiting Syndrome (CVS)', 'interventionNames': ['Other: TMS Paired-Pulse assessment of cortical excitability', 'Other: Autonomic activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'healthy, non-CVS subjects', 'description': 'Subjects not diagnosed with CVS', 'interventionNames': ['Other: TMS Paired-Pulse assessment of cortical excitability', 'Other: Autonomic activity']}], 'interventions': [{'name': 'TMS Paired-Pulse assessment of cortical excitability', 'type': 'OTHER', 'description': 'Using the paired-pulse TMS paradigm, intracortical inhibition and facilitation of cortical circuitry will be assessed by stimulating the motor cortex and using the electromyographic (EMG) response of a target muscle as readout. In such studies, a conditioning stimulus modulates the amplitude of the motor-evoked potential (MEP) produced by the test stimulus. Depending on the inter-stimulus interval, effects can be attributed to different aspects of cortical processing. Brief intervals (1-5 ms) will be used to assess short-interval intracortical inhibition (SICI) and short-interval intracortical facilitation (SICF), intermediate intervals (7-20 ms) to assess intracortical facilitation (ICF) and long intervals (50-200 ms) to assess long-interval intracortical inhibition (LICI).', 'armGroupLabels': ['CVS subjects', 'healthy, non-CVS subjects']}, {'name': 'Autonomic activity', 'type': 'OTHER', 'description': 'Autonomic function will be determined using continuously recorded EKG and used as covariates to investigate any systematic impact on cortical excitability measures collected with the paired-pulse protocols.', 'armGroupLabels': ['CVS subjects', 'healthy, non-CVS subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Paul HM Kullmann, PhD', 'role': 'CONTACT', 'email': 'phmk@pitt.edu', 'phone': '412-647-1533'}, {'name': 'David J Levinthal, MD PhD', 'role': 'CONTACT', 'email': 'levinthald@upmc.edu', 'phone': '412-303-0525'}], 'overallOfficials': [{'name': 'David J Levinthal, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no current plan to place participant data into a open-access, shared data repository. However, a data sharing agreement can be made if requested.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'David Levinthal', 'investigatorAffiliation': 'University of Pittsburgh'}}}}