Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus
Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 25, 2008
CompletedFirst Posted
Study publicly available on registry
April 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 30, 2011
June 1, 2011
3.2 years
April 25, 2008
June 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tinnitus severity with the Tinnitus Questionnaire
after treatment, 1 week, 1, 3 and 6 months
Secondary Outcomes (5)
Tinnitus Handicap Inventory
after treatment, 1 week, 1, 3 and 6 months
Beck Depression Inventory
after treatment, 1 week, 1, 3 and 6 months
State Trait Anxiety Index
after treatment, 1 week, 1, 3 and 6 months
Visual Analog Scales on burden, loudness, pitch, presence, and variability of tinnitus and specific problems.
for the first three months daily and for the second three months monthly
Audiometry and tinnitus analysis (character match, pitch match, loudness match, minimal masking level, residual inhibition)
1 week after treatment and after 3 and 6 months
Study Arms (2)
1
EXPERIMENTAL2
SHAM COMPARATORInterventions
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.
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 Criteria
You may qualify if:
- Chronic, non fluctuating, tinnitus, demonstrated by means of the diagnostic Protocol Tinnitus UMCU, of at least two months duration.
- Age ≥18 years
- Dutch speaking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
Study Sites (1)
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX, Netherlands
Related Publications (1)
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.
PMID: 24157459DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bert A van Zanten, AuD
Dept. of Otorhinolaryngology, University Medical Center Utrecht
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 25, 2008
First Posted
April 29, 2008
Study Start
April 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 30, 2011
Record last verified: 2011-06