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Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus

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ClinicalTrials.gov Identifier: NCT00668720
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : June 30, 2011
Sponsor:
Information provided by:
UMC Utrecht

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tinnitus Device: transcranial magnetic stimulation (Magstim rapid2) Device: sham stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus
Study Start Date : April 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 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.
Other Name: Magstim rapid2
Sham Comparator: 2 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


Outcome Measures
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Primary Outcome Measures :
  1. Tinnitus severity with the Tinnitus Questionnaire [ Time Frame: after treatment, 1 week, 1, 3 and 6 months ]

Secondary Outcome Measures :
  1. Tinnitus Handicap Inventory [ Time Frame: after treatment, 1 week, 1, 3 and 6 months ]
  2. Beck Depression Inventory [ Time Frame: after treatment, 1 week, 1, 3 and 6 months ]
  3. State Trait Anxiety Index [ Time Frame: after treatment, 1 week, 1, 3 and 6 months ]
  4. Visual Analog Scales on burden, loudness, pitch, presence, and variability of tinnitus and specific problems. [ Time Frame: for the first three months daily and for the second three months monthly ]
  5. Audiometry and tinnitus analysis (character match, pitch match, loudness match, minimal masking level, residual inhibition) [ Time Frame: 1 week after treatment and after 3 and 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668720


Locations
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Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Investigators
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Principal Investigator: Bert A van Zanten, AuD Dept. of Otorhinolaryngology, University Medical Center Utrecht
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: dr. G.A. van Zanten, Department of Otorhinolaryngology, University Medical Center Utrecht
ClinicalTrials.gov Identifier: NCT00668720    
Other Study ID Numbers: rTMS_tinnitus_Utrecht
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: June 30, 2011
Last Verified: June 2011
Keywords provided by UMC Utrecht:
tinnitus
transcranial magnetic stimulation
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases