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Sponsored by: |
UMC Utrecht |
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Information provided by: | UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT00668720 |
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.
Condition | Intervention |
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Tinnitus |
Device: transcranial magnetic stimulation (Magstim rapid2) Device: sham stimulation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus |
Estimated Enrollment: | 52 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Device: transcranial 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.
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2: Sham Comparator |
Device: sham 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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carlijn EL Hoekstra, MD | 31-88-755-3606 | c.e.l.hoekstra@umcutrecht.nl |
Contact: Bert A van Zanten, AuD | 31-88-755-3702 | g.a.vanzanten@umcutrecht.nl |
Netherlands | |
University Medical Center Utrecht | Recruiting |
Utrecht, Netherlands, 3584 CX | |
Principal Investigator: Carlijn EL Hoekstra, MD |
Principal Investigator: | Bert A van Zanten, AuD | Dept. of Otorhinolaryngology, University Medical Center Utrecht |
Responsible Party: | Department of Otorhinolaryngology, University Medical Center Utrecht ( dr. G.A. van Zanten ) |
Study ID Numbers: | rTMS_tinnitus_Utrecht |
Study First Received: | April 25, 2008 |
Last Updated: | April 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00668720 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
tinnitus transcranial magnetic stimulation |
Signs and Symptoms Sensation Disorders Hearing Disorders Otorhinolaryngologic Diseases |
Neurologic Manifestations Ear Diseases Tinnitus |
Nervous System Diseases |