TinnitusNCT00668720
Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus
A study testing transcranial magnetic stimulation (Magstim rapid2) in people with Tinnitus, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- transcranial magnetic stimulation (Magstim rapid2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic, non fluctuating, tinnitus, demonstrated by means of the diagnostic Protocol Tinnitus UMCU, of at least two months duration.
- Age ≥18 years
- Dutch speaking
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy (will be tested on the first day of rTMS using a urine pregnancy test)
- Alcohol or drug abuse
- Prior treatment with TMS
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
About this study
Official title: Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic 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.
- Conditions
- Tinnitus
- Being tested
- transcranial magnetic stimulation (Magstim rapid2), sham stimulation
- Keywords
- tinnitus, transcranial magnetic stimulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulation (Magstim rapid2)Device
Also called 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.
sham stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: transcranial magnetic stimulation (Magstim rapid2) |
| 2 | Sham comparator | Not described Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus severity with the Tinnitus Questionnaire
Measured: after treatment, 1 week, 1, 3 and 6 months
Secondary outcomes (5)
Tinnitus Handicap Inventory
Measured: after treatment, 1 week, 1, 3 and 6 months
Beck Depression Inventory
Measured: after treatment, 1 week, 1, 3 and 6 months
State Trait Anxiety Index
Measured: after treatment, 1 week, 1, 3 and 6 months
Visual Analog Scales on burden, loudness, pitch, presence, and variability of tinnitus and specific problems.
Measured: 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)
Measured: 1 week after treatment and after 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Investigators
- Bert A van Zanten, AuD, Principal investigator, Dept. of Otorhinolaryngology, University Medical Center Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668720
- Sponsor's protocol ID
- rTMS_tinnitus_Utrecht
- Status last verified
- Jun 2011
- First submitted
- 25 Apr 2008
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24157459
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT00668720
- Acronym / sponsor ID
- rTMS_tinnitus_Utrecht
- Conditions
- Tinnitus
- Keywords
- tinnitus, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: transcranial magnetic stimulation (Magstim rapid2) |
| 2 | Sham comparator | Device: sham stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic, non fluctuating, tinnitus, demonstrated by means of the diagnostic Protocol Tinnitus UMCU, of at least two months duration.
- Age ≥18 years
- Dutch speaking
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial magnetic stimulation (Magstim rapid2)Also: Magstim rapid2Neuronavigated 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. | Device | 1 |
| sham stimulationThe 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 | Device | 2 |
Primary outcome
Tinnitus severity with the Tinnitus Questionnaire
Time frame: after treatment, 1 week, 1, 3 and 6 months
5 secondary outcomes
Tinnitus Handicap Inventory
Time frame: after treatment, 1 week, 1, 3 and 6 months
Beck Depression Inventory
Time frame: after treatment, 1 week, 1, 3 and 6 months
State Trait Anxiety Index
Time frame: after treatment, 1 week, 1, 3 and 6 months
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
- Derived from this study: PubMed 24157459Hoekstra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bert A van Zanten, AuD principal investigator
Dept. of Otorhinolaryngology, University Medical Center Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation (Magstim rapid2) in people with Tinnitus, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus severity with the Tinnitus Questionnaire (time frame: after treatment, 1 week, 1, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00668720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2011.