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The Effects of Compensatory Auditory Stimulation and Transcranial Direct Current Stimulation on Tinnitus Perception

The Effects of Compensatory Auditory Stimulation and Transcranial Direct Current Stimulation on Tinnitus Perception

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02648542
Enrollment
17
Registered
2016-01-07
Start date
2013-03-31
Completion date
2014-07-31
Last updated
2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Brief summary

This study evaluates the ability of compensatory auditory stimulation (CAS) and transcranial direct current stimulation (tDCS) to help alleviate tinnitus. Subjects will receive CAS, tDCS, and the combination of the two to assess the effectiveness of the treatment.

Detailed description

Tinnitus refers to persistent ringing in the ears in absence of external sound. For some individuals tinnitus can be disabling. Most tinnitus is of idiopathic origin and currently there are no reliable treatment options available. Existing approaches, such as hearing aids, counseling, and noise masking typically provide only partial relief and only for a minority of patients. Newer exploratory methods include tailored auditory stimulation and various brain stimulation techniques. While these techniques show great promise in a subset of subjects (maybe about 1/3), it is hard to anticipate which, if any, will benefit a given patient. Transcranial Direct Current Stimulation (tDCS) has been explored for a number of neurological conditions, and it is most effective when paired with some form of training (e.g. motor rehab after stroke). For tinnitus however this treatment modality has only been tested in isolation. The purpose of this pilot study is to explore the benefits of combining tailored compensatory auditory stimulation with tDCS. There is widespread consensus in the research community that tinnitus originates with some peripheral hearing deficit, and that maladaptive central plastic mechanisms subsequently lead to the tinnitus percept. Most individuals with tinnitus have audiometric evidence of hearing loss. Our hypothesis is that reduced input to the auditory pathway leads to increased sensitivity (auditory gain) and finally aberrant activity in the frequency band with hearing loss. In this view, auditory stimulation that compensates for the reduced input can potentially revert the maladaptive plasticity.This is consistent with the reported benefits of hearing aids and tailored auditory stimulation. Our hypothesis is that tDCS can boost adaptation induced by compensatory auditory stimulation to reduce the strength of the phantom percept.

Interventions

OTHERCompensatory auditory stimulation

Compensating for peripheral hearing loss by adjusting sound levels based on individual audiogram.

DEVICEtranscranial direct current stimulation

Low-current electrical brain stimulation

OTHERCombined CAS and tDCS

Combined auditory and electrical stimulation

OTHERSham stimulation

Sham stimulation

Sponsors

Soterix Medical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Between 18-80 years of age * No history of otological disease * Subjects with hearing loss, hyperacusis and/or tinnitus are eligible to participate

Exclusion criteria

* hearing loss greater than 50 dB HL * Shows signs of depression or anxiety (Zung self-rating Depression Scale \> 50; Beck Anxiety Inventory \> 36)

Design outcomes

Primary

MeasureTime frameDescription
Reduction in minimum masking levels2 weeksMeasurement of the minimum masking level required to mask the subjective tinnitus loudness is assessed after each intervention.
Reduction in tinnitus percept as assessed via the visual analog test of tinnitus loudness2 weeksMeasurement of the subjective loudness of the tinnitus percept is measured using the visual analog scale test after each intervention.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026