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

• 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: Washington University School of Medicine
• 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

Participant Flow

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 And another subject admitted to falsifying his information, he was withdrawn from the study during screening.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
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

Baseline Characteristics

Arm/Group Title		rTMS
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
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

Outcome Measures

1. Primary Outcome

Title	Average Change (Baseline-End of Treatment) Tinnitus Handicap Inventory (THI)
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

Outcome Measure Data

Analysis Population Description

Total number of participants completing the full four weeks of treatment, according to protocol.

Arm/Group Title	rTMS
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	rTMS
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	--/--
Serious Adverse Events
	rTMS
	Affected / at Risk (%)
Total	0/12 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	rTMS
	Affected / at Risk (%)
Total	0/12 (0.00%)

Limitations and Caveats

Open label study.

More Information

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
• EMail: piccirilloj@ent.wustl.edu

• 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