Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus

This study has been completed.
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00668720
First received: April 25, 2008
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

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
Tinnitus
Device: transcranial magnetic stimulation (Magstim rapid2)
Device: sham stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Tinnitus severity with the Tinnitus Questionnaire [ Time Frame: after treatment, 1 week, 1, 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tinnitus Handicap Inventory [ Time Frame: after treatment, 1 week, 1, 3 and 6 months ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: after treatment, 1 week, 1, 3 and 6 months ] [ Designated as safety issue: No ]
  • State Trait Anxiety Index [ Time Frame: after treatment, 1 week, 1, 3 and 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: April 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668720

Locations
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Bert A van Zanten, AuD Dept. of Otorhinolaryngology, University Medical Center Utrecht
  More Information

No publications provided

Responsible Party: dr. G.A. van Zanten, Department of Otorhinolaryngology, University Medical Center Utrecht
ClinicalTrials.gov Identifier: NCT00668720     History of Changes
Other Study ID Numbers: rTMS_tinnitus_Utrecht
Study First Received: April 25, 2008
Last Updated: June 29, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
tinnitus
transcranial magnetic stimulation

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014