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Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus

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: NCT00329524
Recruitment Status : Completed
First Posted : May 24, 2006
Results First Posted : August 7, 2009
Last Update Posted : May 4, 2015
Sponsor:
Collaborator:
Tinnitus Research Consortium
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Tinnitus
Intervention Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Versus Sham TMS
Hide Arm/Group Description Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Active Versus Sham TMS
Hide Arm/Group Description Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
50  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
0
   0.0%
Male
5
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Change in PET Asymmetry Index
Hide Description Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx
Time Frame After active treatment week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Versus Sham TMS
Hide Arm/Group Description:
Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: ratio
1.2  (2.3)
2.Secondary Outcome
Title Psychomotor Vigilance
Hide Description Change in simple auditory reaction time after treatment
Time Frame Immediately after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Active Versus Sham TMS
Hide Arm/Group Description:
Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: milliseconds
-30  (18.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Versus Sham TMS
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Power analysis based on paired t-test.
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx
Hide Description Rating of tinnitus loudness using a scale of 0-100 for
Time Frame immediately following active and sham TMS
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Versus Sham TMS
Hide Arm/Group Description:
Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: analog rating
2.5  (1.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Versus Sham TMS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method test for order effect
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Versus Sham Treatment
Hide Arm/Group Description

Subjects randomly assigned to active and sham TMS separated by one week interval.

Repetitive Transcranial Magnetic Stimulation (rTMS): TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging. TMS will then be optimized by identifying the area of maximal tinnitus suppression, within the area of asymmetry, by delivering single 1-Hz pulses of TMS at the MT. The area of maximal tinnitus suppression, as reported by the patient, will then be targeted for treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days.If no area of maximal tinnitus suppression can be found in the hemisphere initially targeted for treatment based on PET, we will perform the optimization procedure in a homologous region of the opposite cerebral hemisphere to determine if maximal area of suppression can be found there. Each group will then crossover to sham and active stimulation conditions, respectiv

All-Cause Mortality
Active Versus Sham Treatment
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Active Versus Sham Treatment
Affected / at Risk (%)
Total   0/5 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Versus Sham Treatment
Affected / at Risk (%)
Total   0/5 (0.00%) 
Study was ended early and analysis was limited to only 5 subjects. A follow up study using a revised protocol is underway.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Dornhoffer, MD
Organization: UAMS Department of Otolaryngology
Phone: 501-686-7000
EMail: dornhofferjohnl@uams.edu
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00329524    
Other Study ID Numbers: 51817
First Submitted: May 22, 2006
First Posted: May 24, 2006
Results First Submitted: June 17, 2009
Results First Posted: August 7, 2009
Last Update Posted: May 4, 2015