Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-28 @ 8:32 PM
Study NCT ID:
NCT00004366
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Vestibular Rehabilitation Training for Panic Disorder With Vestibular Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D000379', 'term': 'Agoraphobia'}, {'id': 'D016584', 'term': 'Panic Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'ECT'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2000-06', 'completionDateStruct': {'date': '2000-05'}, 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-10-18', 'studyFirstSubmitQcDate': '1999-10-18', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-10-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['agoraphobia', 'anxiety disorder', 'disease-related problem/condition', 'neurologic and psychiatric disorders', 'panic disorder', 'rare disease', 'vestibular diseases'], 'conditions': ['Vestibular Diseases', 'Agoraphobia', 'Panic Disorder']}, 'descriptionModule': {'briefSummary': 'OBJECTIVES:\n\nI. Evaluate whether vestibular rehabilitation training is of value in reducing anxiety symptoms in patients with panic disorder with or without agoraphobia who have vestibular dysfunction as identified by clinical vestibular tests.', 'detailedDescription': 'PROTOCOL OUTLINE: During the first 4 weeks of study, patients meet with a clinical nurse specialist once a week for approximately 1 hour. During this time, the nature of the anxiety disorder is explained and exposure to previously feared situations is encouraged.\n\nOnly patients who remain symptomatic at a stable level following self-exposure will proceed with rehabilitation training.\n\nPatients meet with a physical therapist once a week for 4 weeks to further evaluate the extent of problems associated with balance. Then, patients undergo weekly 1 hour exercises for 8 weeks with the physical therapist, focusing on sensation, head and eye coordination, movement with eyes opened and closed, and gait.\n\nConcurrently, patients meet with the clinical nurse specialist every 4 weeks during and after physical therapy to evaluate the effects of vestibular treatment on anxiety symptoms.\n\nTraining is continued if patient is symptomatic; otherwise, patient is discharged from study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Diagnosed panic disorder with or without agoraphobia\n* Vestibular dysfunction, as defined by abnormalities in the caloric and/or rotational tests\n* Continued symptomatology after general instructions of the importance of exposure to feared situations\n* Absence of acute symptoms of anxiety or depression assessed to need immediate clinical care'}, 'identificationModule': {'nctId': 'NCT00004366', 'briefTitle': 'Pilot Study of Vestibular Rehabilitation Training for Panic Disorder With Vestibular Dysfunction', 'organization': {'class': 'NIH', 'fullName': 'Office of Rare Diseases (ORD)'}, 'orgStudyIdInfo': {'id': '199/11944'}, 'secondaryIdInfos': [{'id': 'UPITTS-11760S-950866'}, {'id': '11760S-950866'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Physical therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rolf G. Jacob', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, 'collaborators': [{'name': 'University of Pittsburgh', 'class': 'OTHER'}]}}}