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van CCT (UK)

van CCT (UK)

Repetitive Transcranial Magnetic Stimulation (rTMS) treatment for chronic tinnitus.

- candidate number3227
- NTR NumberNTR1293
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-apr-2008
- Secondary IDs07-286/O  METC nummer UMC Utrecht
- Public TitleRepetitive Transcranial Magnetic Stimulation (rTMS) treatment for chronic tinnitus.
- Scientific TitleEffectiveness of repetitive Transcranial Magnetic Stimulation (rTMS) treatment in patients with chronic tinnitus.
- hypothesisrTMS 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.
- Healt Condition(s) or Problem(s) studiedTinnitus, Repetitive transcranial magnetic stimulation (rTMS)
- Inclusion criteria1. Chronic, non fluctuating, tinnitus, demonstrated by means of the Diagnostic Protocol Tinnitus UMCU, of at least two months duration.
2. Age >18 years
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-apr-2008
- planned closingdate1-dec-2010
- Target number of participants52
- InterventionsrTMS: bilateral 1Hz, 110% MT, 2000 stimuli on five subsequent days.
- Primary outcomeTinnitus 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)
- Timepointslast 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)
- Trial web siteN/A
- statusinclusion stopped: follow-up
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Otorhinolaryngology and Head & Neck Surgery
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryTinnitus 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.
- Main changes (audit trail)
- RECORD23-apr-2008 - 29-jun-2011

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