Collaborative Tinnitus Research at Washington University (CTRWU)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00567892
First received: December 3, 2007
Last updated: August 23, 2012
Last verified: August 2012
Results First Received: April 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Subjective Tinnitus
Intervention: Device: rTMS

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment period: August, 2008 to June, 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screen failure reasons included: Screening for clinical depression or other significant psychiatric conditions, history of significant head injury, inability to obtain motor threshold with repetitive transcranial magnetic stimulation (rTMS), MRI claustrophobia, and two patients elected not to participate.

Reporting Groups
  Description
Active Then Sham rTMS Treatment (2 Weeks) Active rTMS Treatment for 2 weeks followed by 2 weeks wash-out and then 2 weeks sham. Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
Sham Then Active rTMS Treatment (2 Weeks) Sham treatment for 2 weeks followed by 2 weeks wash-out and then 2 weeks Active rTMS Treatment.Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
Active Then Sham rTMS Treatment (4 Weeks) Active rTMS Treatment for 4 weeks followed by 2 weeks wash-out and then 4 weeks sham.Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.One subject had a drop of THI larger than 20 points from baseline after first arm of treatment and did not get the second arm.
Sham Then Active rTMS Treatment (4 Weeks) Sham treatment for 4 weeks followed by 2 weeks wash-out and then 4 weeks Active rTMS Treatment. Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.

Participant Flow for 3 periods

Period 1:   First Treatment (2 or 4 Weeks)
    Active Then Sham rTMS Treatment (2 Weeks)     Sham Then Active rTMS Treatment (2 Weeks)     Active Then Sham rTMS Treatment (4 Weeks)     Sham Then Active rTMS Treatment (4 Weeks)  
STARTED     7     7     10     10  
COMPLETED     7     7     9     6  
NOT COMPLETED     0     0     1     4  
Withdrawal by Subject                 0                 0                 1                 4  

Period 2:   Washout (2 Weeks)
    Active Then Sham rTMS Treatment (2 Weeks)     Sham Then Active rTMS Treatment (2 Weeks)     Active Then Sham rTMS Treatment (4 Weeks)     Sham Then Active rTMS Treatment (4 Weeks)  
STARTED     7     7     9     6  
COMPLETED     7     7     9     6  
NOT COMPLETED     0     0     0     0  

Period 3:   Second Treatment (2 or 4 Weeks)
    Active Then Sham rTMS Treatment (2 Weeks)     Sham Then Active rTMS Treatment (2 Weeks)     Active Then Sham rTMS Treatment (4 Weeks)     Sham Then Active rTMS Treatment (4 Weeks)  
STARTED     7     7     9     6  
COMPLETED     7     7     9     5  
NOT COMPLETED     0     0     0     1  
Withdrawal by Subject                 0                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
2 Week Treatment Treatment (either active rTMS or sham)for 2 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 2 weeks
4 Week Treatment Treatment (either active rTMS or sham)for 4 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 4 weeks
Total Total of all reporting groups

Baseline Measures
    2 Week Treatment     4 Week Treatment     Total  
Number of Participants  
[units: participants]
  14     20     34  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     20     34  
>=65 years     0     0     0  
Age  
[units: years]
Mean ( Full Range )
  52  
  ( 42 to 59 )  
  42  
  ( 22 to 59 )  
  50  
  ( 22 to 59 )  
Gender  
[units: participants]
     
Female     4     7     11  
Male     10     13     23  
Region of Enrollment  
[units: participants]
     
United States     14     20     34  



  Outcome Measures
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1.  Primary:   Change in THI (Tinnitus Handicap Inventory)   [ Time Frame: baseline at the start of each treatment period, end of each treatment period (2 or 4 weeks) ]

2.  Secondary:   Perceived Global Impression of Change (PGIC: Number of Participants With Perceived Global Impression of Change (PGIC) of 1 or Greater   [ Time Frame: End of each treatment period (2 or 4 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Excluding subjects with Beck Depression Index of above 14 we treated an exclusive group of the Very bothered tinnitus patients, which may not be representative of the tinnitus population as a whole.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jay F. Piccirillo
Organization: Washington University
phone: 314.362.8641
e-mail: piccirilloj@ent.wustl.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Jay F. Piccirillo, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00567892     History of Changes
Other Study ID Numbers: 07-0689, R01DC009095
Study First Received: December 3, 2007
Results First Received: April 11, 2012
Last Updated: August 23, 2012
Health Authority: United States: Federal Government