No registrations found.
ID
Source
Brief title
Health condition
chronic tinnitus
NL: chronische tinnitus, oorsuizen
Sponsors and support
University Medical Centre Utrecht
Intervention
Outcome measures
Primary outcome
Tinnitus severity measured with the tinnitus questionnaire
Secondary outcome
- Tinnitus handicap inventory
- VAS on burden, loudness, pitch, presence, variability and specific problems in daily life
- Beck depression inventory
- State trait anxiety index
- tinnitus analysis (pitch, loudness, minimal masking level, residual inhibition)
Background 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. With this study we intend to answer the question whether rTMS can be an effective treatment for tinnitus.
Study objective
rTMS suppresses neural circuits using a pulsed magnetic field which temporarily excites or inhibits a certain brain area. It is thought that tinnitus is generated in the brain as a result of functional reorganization of auditory neural pathways and tonotopic pathways, leading to a hyperactivity in the central auditory system, following damage to the peripheral auditory system. It is hypothesized that rTMS can supress this hyperactivity and thereby supress tinnitus.
Study design
last rTMS treatment, 1 week after treatment, 1, 3 and 6 months
(VAS's daily for the first three months and monthly for the second three months)
Intervention
rTMS: bilateral 1Hz, 110% MT, 2000 stimuli on five subsequent days.
C.E.L. Hoekstra
Post address: G05.127
Heidelberglaan 100
Utrecht 3584CX
The Netherlands
C.E.L.Hoekstra@umcutrecht.nl
C.E.L. Hoekstra
Post address: G05.127
Heidelberglaan 100
Utrecht 3584CX
The Netherlands
C.E.L.Hoekstra@umcutrecht.nl
Inclusion criteria
1. Chronic, non fluctuating, tinnitus, demonstrated by means of the Diagnostic Protocol Tinnitus UMCU, of at least two months duration.
2. Age >18 years
Exclusion criteria
1. Treatable cause of the tinnitus
2. Use of anticonvulsant medication or other psychotherapeutic drugs
3. History of epilepsy or family members with epilepsy
4. Presence of active migraine
5. Presence of psychiatric, severe internal or heart diseases or other neurologic diseases besides epilepsy
6. Metal objects in and around body that can not be removed
7. Pregnancy (will be tested on the first day of rTMS using a urine pregnancy test)
8. Alcohol or drug abuse
9. Prior treatment with TMS
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1247 |
| NTR-old | NTR1293 |
| Other | METC nummer UMC Utrecht : 07-286/O |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |