Clinical trial NCT00668720: Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus
Official title: Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
transcranial magnetic stimulation
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2008-04-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tinnitus severity with the Tinnitus Questionnaire
timeFrame: after treatment, 1 week, 1, 3 and 6 months
Secondary outcomes:
measure: Tinnitus Handicap Inventory
timeFrame: after treatment, 1 week, 1, 3 and 6 months
measure: Beck Depression Inventory
timeFrame: after treatment, 1 week, 1, 3 and 6 months
measure: State Trait Anxiety Index
timeFrame: after treatment, 1 week, 1, 3 and 6 months
measure: Visual Analog Scales on burden, loudness, pitch, presence, and variability of tinnitus and specific problems.
timeFrame: for the first three months daily and for the second three months monthly
measure: Audiometry and tinnitus analysis (character match, pitch match, loudness match, minimal masking level, residual inhibition)
timeFrame: 1 week after treatment and after 3 and 6 months
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Dept. of Otorhinolaryngology, University Medical Center Utrecht
name: Bert A van Zanten, AuD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoekstra CE, Versnel H, Neggers SF, Niesten ME, van Zanten GA. Bilateral low-frequency repetitive transcranial magnetic stimulation of the auditory cortex in tinnitus patients is not effective: a randomised controlled trial. Audiol Neurootol. 2013;18(6):362-73. doi: 10.1159/000354977. Epub 2013 Oct 19.