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Tinnitus suppression with electrical stimulation.


- candidate number12165
- NTR NumberNTR3374
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-mrt-2012
- Secondary IDs11-2-093 METC MUMC NL38789.068.11
- Public TitleTinnitus suppression with electrical stimulation.
- Scientific TitleTinnitus suppression with electrical stimulation in subjects with single sided deafness.
- ACRONYM
- hypothesisTinnitus (Aurium) is a symptom characterized by the perception of sound or noise in the absence of any objective external physical source. This disorder affects millions of people worldwide; its precise pathophysiologic mechanism is unknown. It has yet remained refractory to current medical treatment. It is supposed that tinnitus might be suppressed by restoring peripheral auditory neural activity. In clinical practice, conventional hearing aids are often used for this purpose with only limited success. When using a cochlear implant (CI), prior studies show tinnitus suppression in 65%-93% of the cases . It is hypothesized that the suppressive effect of electrical stimulation by CI is due to restoring the code of silence in the cochlea and is also feasible with a simple stimulation pattern (i.e. without environmental sound perception). Moreover, it is hypothesized that this effect can be maintained over time.
- Healt Condition(s) or Problem(s) studiedTinnitus
- Inclusion criteria1. Ipsilateral: Severely hearing-impaired;
2. Contralateral: Moderate to normal hearing;
3. Experiencing tinnitus which is:
A. Continuous;
B. Ipsilaterally localized;
C. Characterized as a pure tone;
D. Severe;
E. Stable;
F. No reported suppressive effect from hearing aids.
4. Willingness to participate in this research.
- Exclusion criteria1. Pulsatile tinnitus;
2. Ménière disease;
3. History of psychiatric or neurological disorders or depression;
4. Use of antidepressant medication;
5. Cochleovestibular neurovascular conflict;
6. Congenital malformalities in auditory system;
7. History of vestibular schwannoma;
8. Ossified cochlea;
9. Active middle ear disease;
10. Age < 18 years old.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2012
- planned closingdate1-mrt-2015
- Target number of participants10
- InterventionsControl intervention: Standard CI.
Intervention: Subject specific optimal simple electrical stimulation (i.e. electrical stimulation independent of environmental sounds).
During the crossover study both conditions are alternated in three months intervals.
- Primary outcomeThe primary study variable is the intensity of the experienced tinnitus. The tinnitus intensity will be ranked on a Visual Analogue Scale (VAS).
- Secondary outcome1. Tinnitus Questionnaire;
2. Tinnitus Handicap Inventory;
3. Tinnitus Loudness Matching;
4. Residual Inhibition.
- TimepointsAt regular base after CI implantation for adjustments of CI-settings and during the study.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. R.A.G.J. Arts
- CONTACT for SCIENTIFIC QUERIESProf. dr. R.J. Stokroos
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- PublicationsN/A
- Brief summaryRecruitment will be accomplished in The Netherlands.
- Main changes (audit trail)
- RECORD29-mrt-2012 - 21-mrt-2015


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