Deep Brain Stimulation for Tinnitus

NCT03976908 | Completed DMC

• 1 other identifier: NL67027.068.18
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Tinnitus; Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 1, week 20, week 26, week 33, week 60

Secondary Outcomes (19)

• VAS Loudness

  Week 1, week 12, week 20, week 26, week 33, week 60

• VAS Burden

  Week 1, week 12, week 20, week 26, week 33, week 60

• 15 word memory test

  Week 1, week 27, week 34, week 60

• Boston naming test

  Week 1, week 27, week 34, week 60

• Stroop Color and Word Test

  Week 1, week 27, week 34, week 60

Study Arms (2)

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.

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.

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

High frequency deep brain stimulation in the medial geniculate body of the thalamus.

OFF-ON; ON-OFF

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

MUMC+

Maastricht, 6229HX, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 36648926 DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Mark Janssen, Dr.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical intervention study (double blind, randomized cross-over design). Two different stimulation paradigms will be investigated: ON and OFF stimulation.

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: June 6, 2019
• Study Start: January 6, 2021
• Primary Completion: January 10, 2024
• Study Completion: December 10, 2024
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

NL (1)