TinnitusNCT03976908
Deep Brain Stimulation for Tinnitus
A study testing Deep Brain Stimulation in people with Tinnitus, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Tinnitus is the perception of a sound in the absence of an audible source. Currently up to 15% of the general population suffers chronically from tinnitus. The most severe degree of tinnitus ís experienced by 2.4% of the population and is associated with insomnia, depression; anxiety and even suicide. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Jan 2021to 10 Dec 2024
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically refractory tinnitus. Patient does not respond to available tinnitus treatments (hearing aids, cognitive treatments) and is thoroughly evaluated by the multidisciplinary tinnitus team in MUMC. Thus patients do not respond to both of the following treatments (i.e. TQ is still ≥ 47):
- Hearing aids (except if hearing is normal)
- Evidence-based cognitive treatment in Hoensbroek (Cima et al., 2012) or a similar version of this treatment in the MUMC
- Minimum age 18 years, maximum age 69 years.
- Experiencing tinnitus which is:
- Not pulsatile
Show all 11Show fewer
- Unilateral or bilateral
- Severe tinnitus (based on the TQ score ≥ 47)
- Chronic and stable (present > 2 years and stable > 1 year).
- Bilateral hearing of high tone Fletcher Index < 60 dB
- Willingness to participate in this study (informed consent)
Who cannot join
- Anatomic cause of tinnitus (e.g. vestibular schwannoma, tumour, middle-ear pathology)
- DSM-V psychiatric disorders, other than depression or anxiety disorder (such as bipolar disorder, dementia, addiction, personality disorders); diagnosed by a psychiatrist. A psychiatrist will screen the patients for this matter.
- Depression or anxiety disorder which was already present before tinnitus. A psychiatrist will screen the patients for this matter.
- Cognitive impairment (assessed with standard 'cognitive functioning battery test' questionnaires) or coping problems (CISS-21)
- Active ear diseases that needs further attention according to research team
- Pregnancy or breast-feeding
Show all 9Show fewer
- Active suicide thoughts or attempts
- Underlying malignancies, whenever life expectancy is lower than 2 years
- Other implantable electronic devices that potentially could interfere with DBS, e.g. cochlear implants, auditory brainstem implants or cortical implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Brain Stimulation for Refractory Tinnitus
Tinnitus is the perception of a sound in the absence of an audible source. Currently up to 15% of the general population suffers chronically from tinnitus. The most severe degree of tinnitus ís experienced by 2.4% of the population and is associated with insomnia, depression; anxiety and even suicide. Up to date there is no effective standard therapy. Current therapies mostly focus on treating the distress caused by tinnitus instead of reducing the actual phantom sound. Nevertheless, many patients do not benefit from the current approaches and become severe and chronic tinnitus sufferers. In these patients neuromodulation-based treatments can be a promising option. Tinnitus perception is associated with many complex changes in several different brain structures. The general accepted hypothesis is that neuronal changes occur in both auditory and non-auditory brain structures, most often as a compensating mechanism on reduced input from the auditory nerve caused by cochlear hair cell damage. These central neuronal changes include an increase in spontaneous firing rate, synchronized activity, bursting activity and tonotopic reorganization. In high-frequency deep brain stimulation (DBS) a reversible lesion-like effect is mimicked. From findings in Parkinson's disease patients who also had tinnitus and were treated with DBS, it is known that stimulation can alter or even completely diminish perception of tinnitus. It can be expected that modulation of specific structures within the complex tinnitus pathways can disrupt pathological neuronal activity and thereby alter tinnitus perception or distress caused by this phantom sensation. The investigators found in animal studies that DBS in the central auditory pathway can indeed significantly decrease tinnitus-like behavior. In a questionnaire study the investigators found that around one-fifth of the patients would be reasonably willing to accept invasive treatments and one-fifth would be fully willing to undergo invasive treatment like DBS. Based on preclinical studies and human case studies, the investigators expect that DBS of the central auditory pathway will inhibit tinnitus perception and distress caused by this phantom sensation. Based on studies performed within Maastricht University Medical Center (MUMC), the investigators selected the medial geniculate body of the thalamus (MGB) as the most potential target to treat tinnitus with DBS.
- Conditions
- Tinnitus
- Being tested
- Deep Brain Stimulation
- Keywords
- Tinnitus, Deep Brain Stimulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
High frequency deep brain stimulation in the medial geniculate body of the thalamus.
| Study group | Role | What they receive |
|---|---|---|
| ON-OFF | Experimental | Patients receive the same baseline, a 6 week period of stimulation ON (masked for both patient and investigator), one week of washout, a 6 week period of stimulation OFF (masked for both patient and investigator), one week of washout, a 6 month follow-up period of open-label stimulation ON. Receives: Device: Deep Brain Stimulation |
| OFF-ON | Experimental | Patients receive the same baseline, a 6 week period of stimulation OFF (masked for both patient and investigator), one week of washout, a 6 week period of stimulation ON (masked for both patient and investigator), one week of washout, a 6 month follow-up period of open-label stimulation ON. Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time of the score on the Tinnitus Functional Index
A validated questionnaire which assesses the impact of tinnitus on a patient measured on multiple time points to measure a change over time. The TFI score can range from 0-100, higher values indicate more tinnitus burden. When a patient scores 54 or higher the tinnitus is considered to be a major problem.
Measured: Week 1, week 20, week 26, week 33, week 60
Secondary outcomes (19)
VAS Loudness
on a scale from 0 (no tinnitus) to 10 (most severe tinnitus imaginable), subjects rate their tinnitus perception on loudness.
Measured: Week 1, week 12, week 20, week 26, week 33, week 60
VAS Burden
on a scale from 0 (no tinnitus) to 10 (most severe tinnitus imaginable), subjects rate their tinnitus perception amount of discomfort.
Measured: Week 1, week 12, week 20, week 26, week 33, week 60
15 word memory test
Participants are given a list of 15 unrelated words repeated over five different trials and are asked to repeat. Another list of 15 unrelated words are given and the client must again repeat the original list of 15 words and then again after 30 minutes.
Measured: Week 1, week 27, week 34, week 60
Boston naming test
The neurpsychologist shows the person each of the pictures, one at a time in the given order. The person is given 20 seconds to say what the drawing depicts.
Measured: Week 1, week 27, week 34, week 60
Stroop Color and Word Test
This is a neuropsychological test used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect.
Measured: Week 1, week 27, week 34, week 60
Trail Making Test
This is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.
Measured: Week 1, week 27, week 34, week 60
Semantic Verbal Fluency Test (Animals)
This is a test in which participants have to produce as many words as possible from a category, here animals.
Measured: Week 1, week 27, week 34, week 60
Semantic Verbal Fluency Test (Jobs)
This is a test in which participants have to produce as many words as possible from a category, here jobs.
Measured: Week 1, week 27, week 34, week 60
Phonemic Verbal Fluency Test (D)
This is a test in which participants have to produce as many words as possible from a category, here words starting with the letter D.
Measured: Week 1, week 27, week 34, week 60
Phonemic Verbal Fluency Test (A)
This is a test in which participants have to produce as many words as possible from a category, here words starting with the letter A.
Measured: Week 1, week 27, week 34, week 60
Phonemic Verbal Fluency Test (T)
This is a test in which participants have to produce as many words as possible from a category, here words starting with the letter T.
Measured: Week 1, week 27, week 34, week 60
Quality of life Questionnaire
The Short Form (36) Health Survey (standard validated questionnaire)
Measured: Week 1, week 27, week 34, week 60
Beck Depression Inventory II (BDI-II)
Validated questionnaire for depression.
Measured: Week 1, week 60
Beck Anxiety Inventory (BAI)
Validated questionnaire for anxiety.
Measured: Week 1, week 60
Hospital Anxiety and Depression Scale (HADS)
Validated questionnaire for anxiety and depression.
Measured: Week 1, week 60
Audiometry
pure-tone and speech audiometry. These are the clinical standard audiometric tests.
Measured: Week 1, week 14, week 27, week 34, week 60
Auditory Brainstem Response
Neurophysiological measure following standard protocols.
Measured: Week 1, week 14, week 27, week 34, week 60
Electroencephalography (EEG)
Neurophysiological measure following standard protocols.
Measured: Week 1, week 14, week 27, week 34, week 60
Local Field Potentials (LFP)
Neurophysiological measure following standard protocols.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start6 Jan 2021
- Primary completion10 Jan 2024
- Study completion10 Dec 2024
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.
- 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
- Crossover
- Model description
- Clinical intervention study (double blind, randomized cross-over design). Two different stimulation paradigms will be investigated: ON and OFF stimulation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Janssen, Dr., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976908
- Sponsor's protocol ID
- NL67027.068.18
- Status last verified
- Jul 2025
- First submitted
- 7 Mar 2019
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van Zwieten G, Devos JVP, Kotz SA, Ackermans L, Brinkmann P, Dauven L, George ELJ, Janssen AML, Kremer B, Leue C, Schwartze M, Temel Y, Smit JV, Janssen MLF. A Protocol to Investigate Deep Brain Stimulation for Refractory Tinnitus: From Rat Model to the Set-Up of a Human Pilot Study. Audiol Res. 2022 Dec 31;13(1):49-63. doi: 10.3390/audiolres13010005.
PubMed 36648926
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation for Refractory Tinnitus
- ClinicalTrials.gov ID
- NCT03976908
- Acronym / sponsor ID
- NL67027.068.18
- Conditions
- Tinnitus
- Keywords
- Tinnitus, Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 6 Jun 2019 (actual)
- 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 the perception of a sound in the absence of an audible source. Currently up to 15% of the general population suffers chronically from tinnitus. The most severe degree of tinnitus ís experienced by 2.4% of the population and is associated with insomnia, depression; anxiety and even suicide. Up to date there is no effective standard therapy. Current therapies mostly focus on treating the distress caused by tinnitus instead of reducing the actual phantom sound. Nevertheless, many patients do not benefit from the current approaches and become severe and chronic tinnitus sufferers. In these patients neuromodulation-based treatments can be a promising option. Tinnitus perception is associated with many complex changes in several different brain structures. The general accepted hypothesis is that neuronal changes occur in both auditory and non-auditory brain structures, most often as a compensating mechanism on reduced input from the auditory nerve caused by cochlear hair cell damage. These central neuronal changes include an increase in spontaneous firing rate, synchronized activity, bursting activity and tonotopic reorganization. In high-frequency deep brain stimulation (DBS) a reversible lesion-like effect is mimicked. From findings in Parkinson's disease patients who also had tinnitus and were treated with DBS, it is known that stimulation can alter or even completely diminish perception of tinnitus. It can be expected that modulation of specific structures within the complex tinnitus pathways can disrupt pathological neuronal activity and thereby alter tinnitus perception or distress caused by this phantom sensation. The investigators found in animal studies that DBS in the central auditory pathway can indeed significantly decrease tinnitus-like behavior. In a questionnaire study the investigators found that around one-fifth of the patients would be reasonably willing to accept invasive treatments and one-fifth would be fully willing to undergo invasive treatment like DBS. Based on preclinical studies and human case studies, the investigators expect that DBS of the central auditory pathway will inhibit tinnitus perception and distress caused by this phantom sensation. Based on studies performed within Maastricht University Medical Center (MUMC), the investigators selected the medial geniculate body of the thalamus (MGB) as the most potential target to treat tinnitus with DBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical intervention study (double blind, randomized cross-over design). Two different stimulation paradigms will be investigated: ON and OFF stimulation.
| Arm | Type | Receives |
|---|---|---|
| ON-OFF | Experimental | Device: Deep Brain StimulationPatients receive the same baseline, a 6 week period of stimulation ON (masked for both patient and investigator), one week of washout, a 6 week period of stimulation OFF (masked for both patient and investigator), one week of washout, a 6 month follow-up period of open-label stimulation ON. |
| OFF-ON | Experimental | Device: Deep Brain StimulationPatients receive the same baseline, a 6 week period of stimulation OFF (masked for both patient and investigator), one week of washout, a 6 week period of stimulation ON (masked for both patient and investigator), one week of washout, a 6 month follow-up period of open-label stimulation ON. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Medically refractory tinnitus. Patient does not respond to available tinnitus treatments (hearing aids, cognitive treatments) and is thoroughly evaluated by the multidisciplinary tinnitus team in MUMC. Thus patients do not respond to both of the following treatments (i.e. TQ is still ≥ 47):
- Hearing aids (except if hearing is normal)
- Evidence-based cognitive treatment in Hoensbroek (Cima et al., 2012) or a similar version of this treatment in the MUMC
- Minimum age 18 years, maximum age 69 years.
- Experiencing tinnitus which is:
Key exclusion criteria (9 listed)
- Anatomic cause of tinnitus (e.g. vestibular schwannoma, tumour, middle-ear pathology)
- DSM-V psychiatric disorders, other than depression or anxiety disorder (such as bipolar disorder, dementia, addiction, personality disorders); diagnosed by a psychiatrist. A psychiatrist will screen the patients for this matter.
- Depression or anxiety disorder which was already present before tinnitus. A psychiatrist will screen the patients for this matter.
- Cognitive impairment (assessed with standard 'cognitive functioning battery test' questionnaires) or coping problems (CISS-21)
- Active ear diseases that needs further attention according to research team
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 |
|---|---|---|
| Deep Brain StimulationHigh frequency deep brain stimulation in the medial geniculate body of the thalamus. | Device | OFF-ON, ON-OFF |
Primary outcome
Change over time of the score on the Tinnitus Functional Index
Time frame: Week 1, week 20, week 26, week 33, week 60
A validated questionnaire which assesses the impact of tinnitus on a patient measured on multiple time points to measure a change over time. The TFI score can range from 0-100, higher values indicate more tinnitus burden. When a patient scores 54 or higher the tinnitus is considered to be a major problem.
19 secondary outcomes
VAS Loudness
Time frame: Week 1, week 12, week 20, week 26, week 33, week 60
VAS Burden
Time frame: Week 1, week 12, week 20, week 26, week 33, week 60
15 word memory test
Time frame: Week 1, week 27, week 34, week 60
Boston naming test
Time frame: Week 1, week 27, week 34, week 60
Stroop Color and Word Test
Time frame: Week 1, week 27, week 34, week 60
Trail Making Test
Time frame: Week 1, week 27, week 34, week 60
Semantic Verbal Fluency Test (Animals)
Time frame: Week 1, week 27, week 34, week 60
Semantic Verbal Fluency Test (Jobs)
Time frame: Week 1, week 27, week 34, week 60
Phonemic Verbal Fluency Test (D)
Time frame: Week 1, week 27, week 34, week 60
Phonemic Verbal Fluency Test (A)
Time frame: Week 1, week 27, week 34, week 60
Phonemic Verbal Fluency Test (T)
Time frame: Week 1, week 27, week 34, week 60
Quality of life Questionnaire
Time frame: Week 1, week 27, week 34, week 60
Beck Depression Inventory II (BDI-II)
Time frame: Week 1, week 60
Beck Anxiety Inventory (BAI)
Time frame: Week 1, week 60
Hospital Anxiety and Depression Scale (HADS)
Time frame: Week 1, week 60
Audiometry
Time frame: Week 1, week 14, week 27, week 34, week 60
Auditory Brainstem Response
Time frame: Week 1, week 14, week 27, week 34, week 60
Electroencephalography (EEG)
Time frame: Week 1, week 14, week 27, week 34, week 60
Local Field Potentials (LFP)
Time frame: Week 12
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 18 Jul 2025.
- Derived from this study: PubMed 36648926van Zwieten G, Devos JVP, Kotz SA, Ackermans L, Brinkmann P, Dauven L, George ELJ, Janssen AML, Kremer B, Leue C, Schwartze M, Temel Y, Smit JV, Janssen MLF. A Protocol to Investigate Deep Brain Stimulation for Refractory Tinnitus: From Rat Model to the Set-Up of a Human Pilot Study. Audiol Res. 2022 Dec 31;13(1):49-63. doi: 10.3390/audiolres13010005.
- Individual participant dataSharing planned: Undecided
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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.
Mark Janssen, Dr. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Tinnitus, run by Maastricht University Medical Center 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 11 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 18 Jul 2025. 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. 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?
Change over time of the score on the Tinnitus Functional Index (time frame: Week 1, week 20, week 26, week 33, week 60). 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 NCT03976908, 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 18 Jul 2025.