Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

rTMS Bimodal Treatment For Tinnitus: A Pilot Study

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: NCT01590264
Recruitment Status : Completed
First Posted : May 2, 2012
Results First Posted : April 2, 2013
Last Update Posted : April 2, 2013
Sponsor:
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tinnitus
Intervention Device: Bimodal rTMS
Enrollment 5
Recruitment Details All subjects were recruited from Washington University Otolaryngology and Audiology clinics.
Pre-assignment Details Subjects were enrolled for one pre-treatments screening visits, received two weeks of rTMS treatment, and were assessed at the last treatment day. There was no additional follow-up.
Arm/Group Title Bimodal rTMS
Hide Arm/Group Description

Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)

Stimulation Settings:

DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000

TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000

Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Bimodal rTMS
Hide Arm/Group Description

Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)

Stimulation Settings:

DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000

TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000

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
55  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
1
  20.0%
Male
4
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Adverse Events
Hide Description Subject will be queried for Adverse Events daily for 2 weeks of treatment. This is foremost a feasibility study, so measure of Adverse Events and relation to treatment is primary outcome.
Time Frame Daily for 2 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Pilot study based on convenience sample.
Arm/Group Title Bimodal rTMS
Hide Arm/Group Description:

Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)

Stimulation Settings:

DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000

TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000

Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Change in Tinnitus Handicap Inventory
Hide Description Participant will complete the Tinnitus Handicap Inventory (THI)at the end of 2 weeks of treatment. Difference of the THI post treatmement minus baseline THI was calculated. Scale ranges in scores from 0 to 100 with 0 = no bother and 100 being the most bothered.
Time Frame Baseline, 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Pilot study convenience sample
Arm/Group Title Bimodal rTMS
Hide Arm/Group Description:

Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)

Stimulation Settings:

DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000

TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000

Overall Number of Participants Analyzed 5
Median (Full Range)
Unit of Measure: units on a scale
-12
(-26 to 0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bimodal rTMS
Hide Arm/Group Description

Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)

Stimulation Settings:

DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000

TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000

All-Cause Mortality
Bimodal rTMS
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bimodal rTMS
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bimodal rTMS
Affected / at Risk (%)
Total   0/5 (0.00%) 
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 in Saint Louis
Phone: 314-362-8641
Responsible Party: Jay F. Piccirillo, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01590264     History of Changes
Other Study ID Numbers: 201204069
First Submitted: April 30, 2012
First Posted: May 2, 2012
Results First Submitted: September 17, 2012
Results First Posted: April 2, 2013
Last Update Posted: April 2, 2013