N/A
N=39
Effect of rTMS on Resting State Brain Activity in Tinnitus
Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT00926237 ↗Enrolled (actual)
39
Serious AEs
1.7%
Results posted
Nov 2020
Primary outcome: Primary: Change From Baseline on the Analogue Rating of Tinnitus Awareness. — -4.08; -4.70; -9.82; -9.89 units on a scale — p=.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sham rTMS - Sham repetitive transcranial magnetic stimulation (Device); Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequency (Device); Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequency (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline on the Analogue Rating of Tinnitus Awareness. |
-4.08; -4.70; -9.82; -9.89; -10.85; -9.43 | .04 sig |
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 have been shown to decrease tinnitus awareness. The purpose of this study is to evaluate a treatment option for tinnitus that uses a technique called Repetitive Transcranial Magnetic Stimulation (rTMS), which could prove to be an effective means of alleviating or reducing the symptoms of tinnitus.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00926237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.