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

NCT ID: NCT02648542

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CAS vs. tDCS

Assess the efficacy of compensatory auditory stimulation (CAS) versus transcranial direct current stimulation (tDCS)

Group Type ACTIVE_COMPARATOR

Compensatory auditory stimulation

Intervention Type OTHER

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

transcranial direct current stimulation

Intervention Type DEVICE

Low-current electrical brain stimulation

Combined CAS+tDCS vs. Sham

Assess the efficacy of combined compensatory auditory stimulation (CAS) + transcranial direct current stimulation (tDCS) versus sham stimulation

Group Type SHAM_COMPARATOR

Combined CAS and tDCS

Intervention Type OTHER

Combined auditory and electrical stimulation

Sham stimulation

Intervention Type OTHER

Sham stimulation

Interventions

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Compensatory auditory stimulation

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

Intervention Type OTHER

transcranial direct current stimulation

Low-current electrical brain stimulation

Intervention Type DEVICE

Combined CAS and tDCS

Combined auditory and electrical stimulation

Intervention Type OTHER

Sham stimulation

Sham stimulation

Intervention Type OTHER

Other Intervention Names

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CAS tDCS CAS + tDCS Sham

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Soterix Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucas C Parra, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

City College of New York, CUNY

Other Identifiers

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CASTDCS001

Identifier Type: -

Identifier Source: org_study_id