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Completed

NCT Number: NCT00668720

Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcranial magnetic stimulation (Magstim rapid2)

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.

Other names: Magstim rapid2

Sham stimulation

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

Primary outcomes

  1. Tinnitus severity with the Tinnitus Questionnaire

    Time frame: after treatment, 1 week, 1, 3 and 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 29, 2008
Registry last updated
Jun 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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