Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study of Vestibular Rehabilitation Training for Panic Disorder With Vestibular Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004366
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by:
Office of Rare Diseases (ORD)

Tracking Information
First Submitted Date  ICMJE October 18, 1999
First Posted Date  ICMJE October 19, 1999
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE August 1995
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Vestibular Rehabilitation Training for Panic Disorder With Vestibular Dysfunction
Official Title  ICMJE Not Provided
Brief Summary

OBJECTIVES:

I. 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.

Detailed Description

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.

Only patients who remain symptomatic at a stable level following self-exposure will proceed with rehabilitation training.

Patients 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.

Concurrently, 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.

Training is continued if patient is symptomatic; otherwise, patient is discharged from study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Educational/Counseling/Training
Condition  ICMJE
  • Vestibular Diseases
  • Agoraphobia
  • Panic Disorder
Intervention  ICMJE Procedure: Physical therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
20
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2000
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE
  • Diagnosed panic disorder with or without agoraphobia
  • Vestibular dysfunction, as defined by abnormalities in the caloric and/or rotational tests
  • Continued symptomatology after general instructions of the importance of exposure to feared situations
  • Absence of acute symptoms of anxiety or depression assessed to need immediate clinical care
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004366
Other Study ID Numbers  ICMJE 199/11944
UPITTS-11760S-950866
11760S-950866
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Center for Research Resources (NCRR)
Collaborators  ICMJE University of Pittsburgh
Investigators  ICMJE
Study Chair: Rolf G. Jacob University of Pittsburgh
PRS Account Office of Rare Diseases (ORD)
Verification Date June 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP