Status:
COMPLETED
Effect of rTMS on Resting State Brain Activity in Tinnitus
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Tinnitus
Eligibility:
All Genders
19-89 years
Phase:
NA
Brief Summary
One out of every five people experiences tinnitus (a ringing, buzzing, or roaring sound in the ear) ranging from mild to severe impairment. To date, there are no effective therapies available that hav...
Detailed Description
Up to 60 subjects, including males and females ages 19-89 years old and of all races, and with tinnitus severe enough to seek medical attention, will be enrolled in this study. All participants must b...
Eligibility Criteria
Inclusion
- Inclusion Criteria per protocol and informed consent:
- Diagnosis of tinnitus established through a history and physical exam or review of records.
- Subjects 19-89 years of age
- Tinnitus present for at least 6 months and severe enough to seek medical attention
- Subjects taking SSRI's (a class of anti-depressant medications)and benzodiazepines (a class of anti-anxiety medications) for depression or anxiety related to tinnitus must be stable on their current dose for at least 3 months and must not alter their dose or medication during their involvement with this study
- Subjects must agree to avoid consuming alcohol within 72 hours of each rTMS session
- Female subjects of childbearing potential must demonstrate a negative pregnancy test during their initial clinic visit and must agree to use effective contraception during their participation in this study
- Subjects must sign an informed consent and agree to comply with study and follow-up procedures, including completion of all necessary questionnaires and testing, as well as, being video-recorded for safety purposes during rTMS sessions
- Subjects must speak and comprehend English adequately to understand and complete any study-related instructions and questionnaires
- Exclusion Criteria per protocol and informed consent:
- For rTMS
- Subjects or any of their 1st-degree relatives must not have been diagnosed with epilepsy
- Subjects must not have a history of seizure disorder or migraines
- Subjects must not have any history of a brain aneurysm, stroke, previous cranial neurosurgery, acoustic neuroma, glomus tumor, active Menniere's Disease, profound hearing loss (greater than 90 dB at 4000 Hz), or any major neurological or psychiatric disorders (excluding depression or anxiety related to tinnitus)
- Medications that lower seizure threshold or reduce cortical excitation (i.e., tricyclic antidepressants, bupropion or anticonvulsants)
- Subjects must not have any history of a head injury that resulted in a loss of consciousness for more than 10 minutes
- Subjects must not be pregnant or refuse to utilize effective contraception during their participation in this study For MRI
- Subjects must not have any metal implants or devices in the head or neck or a pacemaker.
- Subjects must not have severe claustrophobia if they are to have an MRI.
- Significant abnormalities must not be present on acquired or existing CT or MRI image of the head.
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00926237
Start Date
January 1 2009
End Date
September 1 2019
Last Update
November 20 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205