Tinnitus
Conditions
Keywords
tinnitus, transcranial magnetic stimulation
Brief summary
Tinnitus is a phantom auditory perception of meaningless sound, meaning that there is registration of sound in the absence of an external or internal acoustic stimulus. It is a common problem (prevalence 7-19%) which may interfere with the ability to lead a normal life. Unfortunately, it is a very difficult symptom to treat because there are hardly any therapeutic options for the cause of tinnitus. Most therapies focus on alleviating the condition rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Repetitive Transcranial magnetic stimulation (rTMS) is a therapy, based on this concept of reorganization in the auditory cortex. It uses a pulsed magnetic field to disrupt the neural circuit and to thereby (temporarily) excite or inhibit certain brain areas, leading to the suppression of tinnitus.
Interventions
DEVICEtranscranial magnetic stimulation (Magstim rapid2)
Neuronavigated rTMS will be applied bilaterally to the auditory cortices, which will be identified through a structural MRI scan. Stimulation will be performed with 1 Hz frequency and an intensity of 110% motor threshold for 2000 stimuli (32 minutes) on each side, on five subsequent days.
DEVICEsham stimulation
The official sham stimulator for the magstim rapid2 will be used. Sham stimulation will follow the same placement protocol and will also last 2x32 minutes on five subsequent days
Sponsors
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic, non fluctuating, tinnitus, demonstrated by means of the diagnostic Protocol Tinnitus UMCU, of at least two months duration. * Age ≥18 years * Dutch speaking
Exclusion criteria
* Treatable cause of the tinnitus * Use of anticonvulsant medication or other psychotherapeutic drugs * History of epilepsy or family members with epilepsy * Presence of active migraine * Presence of psychiatric, severe internal or heart diseases or other neurologic diseases besides epilepsy * Metal objects in and around body that can not be removed * Pregnancy (will be tested on the first day of rTMS using a urine pregnancy test) * Alcohol or drug abuse * Prior treatment with TMS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tinnitus severity with the Tinnitus Questionnaire | after treatment, 1 week, 1, 3 and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Beck Depression Inventory | after treatment, 1 week, 1, 3 and 6 months |
| Tinnitus Handicap Inventory | after treatment, 1 week, 1, 3 and 6 months |
| State Trait Anxiety Index | after treatment, 1 week, 1, 3 and 6 months |
| Visual Analog Scales on burden, loudness, pitch, presence, and variability of tinnitus and specific problems. | for the first three months daily and for the second three months monthly |
| Audiometry and tinnitus analysis (character match, pitch match, loudness match, minimal masking level, residual inhibition) | 1 week after treatment and after 3 and 6 months |
Countries
Netherlands
Outcome results
None listed