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rTMS To The Dorsolateral Prefrontal Cortex For Patients With Subjective Idiopathic Tinnitus. A Pilot Study

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ClinicalTrials.gov Identifier: NCT00886938
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : May 21, 2012
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tinnitus
Intervention Device: Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study
Enrollment 12
Recruitment Details Recruitment Period: 06/2009-08/2010 Subjects recruited from Washington University Clinics and from Washington University Volunteers for Health.
Pre-assignment Details Screening for Motor Threshold with rTMS magnet resulted in screen failure for one subject. Screening for psych history with psychiatrist screen failed one subject. And another subject admitted to falsifying his information, he was withdrawn from the study during screening.
Arm/Group Title rTMS
Hide Arm/Group Description rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
Period Title: Overall Study
Started 12
Completed 10
Not Completed 2
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Arm/Group Title rTMS
Hide Arm/Group Description rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
51
(45 to 57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
7
  58.3%
Male
5
  41.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Average Change (Baseline-End of Treatment) Tinnitus Handicap Inventory (THI)
Hide Description Patient self-reported Tinnitus Handicap Inventory (THI) The mean change (95% CI) in THI scores (Baseline - End of Treatment). Measures tinnitus severity, or how much tinnitus interrupts their life. The THI scores range from 0-100. 0 being no interruption, 100 being severe interruption in their life from tinnitus.
Time Frame 0,4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of participants completing the full four weeks of treatment, according to protocol.
Arm/Group Title rTMS
Hide Arm/Group Description:
rTMS to the left dorsolateral prefrontal cortex for patients with tinnitus
Overall Number of Participants Analyzed 10
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
10.7
(2.4 to 19)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title rTMS
Hide Arm/Group Description rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
All-Cause Mortality
rTMS
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
rTMS
Affected / at Risk (%)
Total   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
rTMS
Affected / at Risk (%)
Total   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jay F Piccirillo
Organization: Washington University
Phone: (314) 362-8641
EMail: piccirilloj@ent.wustl.edu
Layout table for additonal information
Responsible Party: Jay F. Piccirillo, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00886938    
Other Study ID Numbers: 09-0551
First Submitted: April 22, 2009
First Posted: April 23, 2009
Results First Submitted: March 7, 2012
Results First Posted: May 21, 2012
Last Update Posted: May 16, 2014