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Transcranial Magnetic Stimulation for Tinnitus

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ClinicalTrials.gov Identifier: NCT01104207
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : February 23, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Other
Condition Tinnitus
Interventions Device: repetitive transcranial magnetic stimulation (rTMS)
Device: placebo rTMS
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description

For half of the subjects, rTMS will be delivered to one side of the head.

repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception.

For half of the subjects, placebo rTMS will be delivered to one side of the head.

placebo rTMS: placebo rTMS

Period Title: Overall Study
Started 35 35
Completed 32 32
Not Completed 3 3
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description

For half of the subjects, rTMS will be delivered to one side of the head.

repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception.

For half of the subjects, placebo rTMS will be delivered to one side of the head.

placebo rTMS: placebo rTMS

Total of all reporting groups
Overall Number of Baseline Participants 35 35 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  71.4%
19
  54.3%
44
  62.9%
>=65 years
10
  28.6%
16
  45.7%
26
  37.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 35 participants 70 participants
58.3  (9.5) 62.8  (8.3) 60.6  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Female
7
  20.0%
7
  20.0%
14
  20.0%
Male
28
  80.0%
28
  80.0%
56
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 35 participants 70 participants
35 35 70
Tinnitus Functional Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 35 participants 35 participants 70 participants
44.8  (19.4) 40.6  (22.2) 42.7  (20.8)
[1]
Measure Description: The TFI is a 25-item questionnaire that assesses tinnitus severity. The possible range of scores for the TFI is 0 to 100, with higher scores indicating more severe tinnitus.
1.Primary Outcome
Title Change in Tinnitus Functional Index (TFI) Score
Hide Description The TFI is a 25-item questionnaire that assesses tinnitus severity. The possible range of scores for the TFI is 0 to 100, with higher scores indicating more severe tinnitus.
Time Frame 26 weeks post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

For half of the subjects, rTMS will be delivered to one side of the head.

repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception.

For half of the subjects, placebo rTMS will be delivered to one side of the head.

placebo rTMS: placebo rTMS

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: units on TFI scale; change from baseline
-13.8  (15.2) -2.9  (15.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description

For half of the subjects, rTMS will be delivered to one side of the head.

repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception.

For half of the subjects, placebo rTMS will be delivered to one side of the head.

placebo rTMS: placebo rTMS

All-Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (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: Robert L. Folmer, Ph.D.
Organization: VA Portland Medical Center
Phone: 503-220-8262 ext 51868
EMail: Robert.Folmer@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01104207    
Other Study ID Numbers: C7448-I
First Submitted: April 13, 2010
First Posted: April 15, 2010
Results First Submitted: January 4, 2017
Results First Posted: February 23, 2017
Last Update Posted: March 29, 2017