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
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|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Diagnosis of chronic tinnitus.
- Able to provide written informed consent.
- Subject is naive regarding rTMS.
- Age/Gender: minimum 18 years old, with an attempt to sample equal numbers of male and female subjects.
- Other concurrent treatments: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study.
- Other medications: No restrictions, provided the dosages have been in place for at least 6 months.
- Psychological status: Stable enough to complete this study per the opinion of the Study Physician.
- Hearing function: All degrees of hearing function can be included recognizing that profound, bilateral losses will not be able to perform tinnitus evaluations and hearing tests, but will be able to rate subjective tinnitus loudness, annoyance and impact on life. This is an important subpopulation because of the challenges in treating them with acoustic therapy and the need for a medical intervention.
Tinnitus characteristics: All forms of tinnitus etiology will be accepted, providing the following criteria are met:
- Tinnitus duration: Not less than 1 year. Cases of less than 1 year duration have increased likelihood of resolving spontaneously.
- Stability: Constant (not pulsatile, intermittent, varying to a high degree in loudness or changing in location of perception). Fluctuating tinnitus reduces the reliability of test-retest measures for loudness.
- Self-rated tinnitus loudness: >= 6 on a visual numerical scale (VNS: 0 labeled "No Tinnitus", 10 labeled "Very Loud"). This outcome measure will provide a subjective indication of immediate changes in perceived loudness.
- Location of tinnitus perception: Unrestricted. Tinnitus may be unilateral, bilateral, or perceived in the head.
- Medical conditions: No active neurologic or otologic disease processes that may impact tinnitus perception. No auto-immune diseases. No pregnancy or planned pregnancy during the study. No women who are lactating or are of child-bearing-age without using contraception.
- Objective Tinnitus - tinnitus that is audible to other people in addition to the patient. This type of tinnitus is rare and is unlikely to respond to rTMS because it is not associated with abnormal neural activity in the central auditory system.
- History or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events (such as strokes), neurodegenerative disorders affecting the brain (such as Parkinson's Disease, ALS, Huntington's Disease or Multiple Sclerosis) or prior brain surgery.
- Cardiac pace makers, other electronic implants (including cochlear implants), intracranial or intraocular metallic particles.
- History of seizures or epileptic activity.
- Patients who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the trial.
- Participation in a clinical trial within the last 30 days before the start of this one.
- Maximum number of previous clinical trials for tinnitus in which subjects may have participated: two.
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|
|Responsible Party:||VA Office of Research and Development|
|Other Study ID Numbers:||
|First Posted:||April 15, 2010 Key Record Dates|
|Results First Posted:||February 23, 2017|
|Last Update Posted:||March 29, 2017|
|Last Verified:||February 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
transcranial magnetic stimulation
Nervous System Diseases