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Transcranial Magnetic Stimulation for Tinnitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01104207
First received: April 13, 2010
Last updated: February 27, 2017
Last verified: February 2017
Results First Received: January 4, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1

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.

Arm 2

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

placebo rTMS: placebo rTMS


Participant Flow:   Overall Study
    Arm 1   Arm 2
STARTED   35   35 
COMPLETED   32   32 
NOT COMPLETED   3   3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1

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.

Arm 2

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

placebo rTMS: placebo rTMS

Total Total of all reporting groups

Baseline Measures
   Arm 1   Arm 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   35   70 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 58.3  (9.5)   62.8  (8.3)   60.6  (8.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  20.0%      7  20.0%      14  20.0% 
Male      28  80.0%      28  80.0%      56  80.0% 
Region of Enrollment 
[Units: Participants]
     
United States   35   35   70 
Tinnitus Functional Index [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 44.8  (19.4)   40.6  (22.2)   42.7  (20.8) 
[1] 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.


  Outcome Measures

1.  Primary:   Change in Tinnitus Functional Index (TFI) Score   [ Time Frame: 26 weeks post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert L. Folmer, Ph.D.
Organization: VA Portland Medical Center
phone: 503-220-8262 ext 51868
e-mail: Robert.Folmer@va.gov


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01104207     History of Changes
Other Study ID Numbers: C7448-I
Study First Received: April 13, 2010
Results First Received: January 4, 2017
Last Updated: February 27, 2017