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Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus

NCT ID: NCT00668720

Last Updated: 2011-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tinnitus

Keywords

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tinnitus transcranial magnetic stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

transcranial magnetic stimulation (Magstim rapid2)

Intervention Type DEVICE

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.

2

Group Type SHAM_COMPARATOR

sham stimulation

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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Magstim rapid2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Department of Otorhinolaryngology, University Medical Center Utrecht

Principal Investigators

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Bert A van Zanten, AuD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Otorhinolaryngology, University Medical Center Utrecht

Locations

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University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 24157459 (View on PubMed)

Other Identifiers

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rTMS_tinnitus_Utrecht

Identifier Type: -

Identifier Source: org_study_id