Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-28 @ 8:30 PM
Study NCT ID:
NCT01454557
Status:
UNKNOWN
Last Update Posted:
2011-11-01
First Post:
2011-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Auditory Stimuli on Heart Rate Variability (HRV) Among Patients With Acquired Brain Injury (ABI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'lastUpdateSubmitDate': '2011-10-31', 'studyFirstSubmitDate': '2011-10-10', 'studyFirstSubmitQcDate': '2011-10-17', 'lastUpdatePostDateStruct': {'date': '2011-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate Variability', 'timeFrame': 'first measurement: 2 weeks to 2 months from hospitalization to the department: 24 hours EKG follow up for HRV base line. Last measurement: before the release from rehabilitation (up to 12 months).', 'description': 'Heart Rate Variability as measured by HOLTER EKG during the 4 different conditions: first measuerement 2-8 weeks from hospitalization in the TBI rehabilitation department-24 hours detection for HRV baseline. Second measurement: a week after: EKG during the 4 conditions. Third measurement:a month after the first measure, Fourth measurement: 2 months after the first one. Last measurement: Before the release home from rehabilitation (up to one year from the first measurement).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acquired Brain Injury', 'Heart Rate Variability (HRV)', 'Auditory Stimuli', 'Physical Activity'], 'conditions': ['Acquired Brain Injury']}, 'descriptionModule': {'briefSummary': 'Heart Rate Variability (HRV) reflects the responsiveness of the autonomic system to an external stimuli. The aim of this system is to maintain homeostasis.The variability implies on the interaction between the sympathetic and the parasympathetic systems to maintain the ongoing changes of the autonomic system. Following Acquired Brain Injury (ABI), there can be a damage to the Central Nervous System (CNS) function. The damages described in the literature are cognitive, motor and behavioural function, while there is less relation to the autonomic system. The autonomic system can influence the ability of patient with ABI to participate in the rehabilitation program. The aim of this work is to investigate the activity of the autonomic system activity as manifested by HRV among patients with ABI in different conditions: resting, during activity and while listening to different auditory stimuli.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2-4 months from acceptance to rehabilitation medical stable\n\nExclusion Criteria:\n\n* medical unstable a significant hearing deficit premorbid neurological or mental condition'}, 'identificationModule': {'nctId': 'NCT01454557', 'briefTitle': 'The Effect of Auditory Stimuli on Heart Rate Variability (HRV) Among Patients With Acquired Brain Injury (ABI)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'The Effect of Auditory Stimuli on Heart Rate Variability (HRV) During Resting and During Physical Activity Among Patients With Acquired Brain Injury (ABI)', 'orgStudyIdInfo': {'id': 'SHEBA-11-8846-OK-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acquired Brain Injury', 'description': 'auditory stimuli for ABI group', 'interventionNames': ['Other: Auditory Stimuli']}, {'type': 'EXPERIMENTAL', 'label': 'Controls', 'description': 'Auditory stimuli for control group', 'interventionNames': ['Other: Auditory Stimuli']}], 'interventions': [{'name': 'Auditory Stimuli', 'type': 'OTHER', 'description': 'Auditory Stimuli during rest and during physical activity', 'armGroupLabels': ['Acquired Brain Injury', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'country': 'Israel', 'contacts': [{'name': 'Aba Ratner, MD', 'role': 'CONTACT', 'email': 'Aba.ratner@sheba.health.gov.il', 'phone': '972-3-5305183'}, {'name': 'Ofer Keren, MD', 'role': 'CONTACT', 'email': 'ofer.keren@sheba.health.gov.il', 'phone': '972-3-5305183'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Ofer Keren, MD', 'role': 'CONTACT', 'email': 'ofer.keren@sheba.health.gov.il', 'phone': '972-3-5305183'}, {'name': 'Aba Ratner, MD', 'role': 'CONTACT', 'email': 'Aba.Ratner@sheba.health.gov.il', 'phone': '972-3-5305183'}], 'overallOfficials': [{'name': 'Ofer Keren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The head of the TBI rehabilitation department', 'investigatorFullName': 'Dr. Ofer Keren', 'investigatorAffiliation': 'Sheba Medical Center'}}}}