Transcranial Magnetic Stimulation for Tinnitus
|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|
|Primary Completion Date :||December 2016|
|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.
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|