Deep Brain Stimulation for Tinnitus

February 9, 2024 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ON-OFF
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
High frequency deep brain stimulation in the medial geniculate body of the thalamus.
Experimental: OFF-ON
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
High frequency deep brain stimulation in the medial geniculate body of the thalamus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 1, week 20, week 26, week 33, week 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS Loudness
Time Frame: Week 1, week 12, week 20, week 26, week 33, week 60
on a scale from 0 (no tinnitus) to 10 (most severe tinnitus imaginable), subjects rate their tinnitus perception on loudness.
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
on a scale from 0 (no tinnitus) to 10 (most severe tinnitus imaginable), subjects rate their tinnitus perception amount of discomfort.
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
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.
Week 1, week 27, week 34, week 60
Boston naming test
Time Frame: Week 1, week 27, week 34, week 60
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.
Week 1, week 27, week 34, week 60
Stroop Color and Word Test
Time Frame: Week 1, week 27, week 34, week 60
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.
Week 1, week 27, week 34, week 60
Trail Making Test
Time Frame: Week 1, week 27, week 34, week 60
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.
Week 1, week 27, week 34, week 60
Semantic Verbal Fluency Test (Animals)
Time Frame: Week 1, week 27, week 34, week 60
This is a test in which participants have to produce as many words as possible from a category, here animals.
Week 1, week 27, week 34, week 60
Semantic Verbal Fluency Test (Jobs)
Time Frame: Week 1, week 27, week 34, week 60
This is a test in which participants have to produce as many words as possible from a category, here jobs.
Week 1, week 27, week 34, week 60
Phonemic Verbal Fluency Test (D)
Time Frame: Week 1, week 27, week 34, week 60
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.
Week 1, week 27, week 34, week 60
Phonemic Verbal Fluency Test (A)
Time Frame: Week 1, week 27, week 34, week 60
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.
Week 1, week 27, week 34, week 60
Phonemic Verbal Fluency Test (T)
Time Frame: Week 1, week 27, week 34, week 60
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.
Week 1, week 27, week 34, week 60
Quality of life Questionnaire
Time Frame: Week 1, week 27, week 34, week 60
The Short Form (36) Health Survey (standard validated questionnaire)
Week 1, week 27, week 34, week 60
Beck Depression Inventory II (BDI-II)
Time Frame: Week 1, week 60
Validated questionnaire for depression.
Week 1, week 60
Beck Anxiety Inventory (BAI)
Time Frame: Week 1, week 60
Validated questionnaire for anxiety.
Week 1, week 60
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Week 1, week 60
Validated questionnaire for anxiety and depression.
Week 1, week 60
Audiometry
Time Frame: Week 1, week 14, week 27, week 34, week 60
pure-tone and speech audiometry. These are the clinical standard audiometric tests.
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
Neurophysiological measure following standard protocols.
Week 1, week 14, week 27, week 34, week 60
Electroencephalography (EEG)
Time Frame: Week 1, week 14, week 27, week 34, week 60
Neurophysiological measure following standard protocols.
Week 1, week 14, week 27, week 34, week 60
Local Field Potentials (LFP)
Time Frame: Week 12
Neurophysiological measure following standard protocols.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Mark Janssen, Dr., Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2021

Primary Completion (Actual)

January 10, 2024

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL67027.068.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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