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
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Device: repetitive transcranial magnetic stimulation (rTMS) Device: placebo rTMS||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Clinical Trial of Transcranial Magnetic Stimulation for Relief of Tinnitus|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Arm 1
Half of the study participants will receive 2000 pulses of 1 Hz active rTMS daily on 10 consecutive work days.
Device: 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.
Sham Comparator: Arm 2
Half of the study participants will receive 2000 pulses of 1 Hz placebo rTMS daily on 10 consecutive work days.
Device: placebo rTMS
- Change in Tinnitus Functional Index (TFI) Score [ Time Frame: 26 weeks post-treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104207
|United States, Oregon|
|VA Portland Health Care System, Portland, OR|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Robert Folmer, PhD||VA Portland Health Care System, Portland, OR|