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

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Compensatory auditory stimulation
transcranial direct current stimulation
Combined CAS and tDCS
Sham stimulation
Sponsored by
Soterix Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    CAS vs. tDCS

    Combined CAS+tDCS vs. Sham

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Reduction in minimum masking levels
    Measurement 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 loudness
    Measurement of the subjective loudness of the tinnitus percept is measured using the visual analog scale test after each intervention.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 30, 2015
    Last Updated
    January 5, 2016
    Sponsor
    Soterix Medical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02648542
    Brief Title
    The Effects of Compensatory Auditory Stimulation and Transcranial Direct Current Stimulation on Tinnitus Perception
    Official Title
    The Effects of Compensatory Auditory Stimulation and Transcranial Direct Current Stimulation on Tinnitus Perception
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Soterix Medical

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinnitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CAS vs. tDCS
    Arm Type
    Active Comparator
    Arm Description
    Assess the efficacy of compensatory auditory stimulation (CAS) versus transcranial direct current stimulation (tDCS)
    Arm Title
    Combined CAS+tDCS vs. Sham
    Arm Type
    Sham Comparator
    Arm Description
    Assess the efficacy of combined compensatory auditory stimulation (CAS) + transcranial direct current stimulation (tDCS) versus sham stimulation
    Intervention Type
    Other
    Intervention Name(s)
    Compensatory auditory stimulation
    Other Intervention Name(s)
    CAS
    Intervention Description
    Compensating for peripheral hearing loss by adjusting sound levels based on individual audiogram.
    Intervention Type
    Device
    Intervention Name(s)
    transcranial direct current stimulation
    Other Intervention Name(s)
    tDCS
    Intervention Description
    Low-current electrical brain stimulation
    Intervention Type
    Other
    Intervention Name(s)
    Combined CAS and tDCS
    Other Intervention Name(s)
    CAS + tDCS
    Intervention Description
    Combined auditory and electrical stimulation
    Intervention Type
    Other
    Intervention Name(s)
    Sham stimulation
    Other Intervention Name(s)
    Sham
    Intervention Description
    Sham stimulation
    Primary Outcome Measure Information:
    Title
    Reduction in minimum masking levels
    Description
    Measurement of the minimum masking level required to mask the subjective tinnitus loudness is assessed after each intervention.
    Time Frame
    2 weeks
    Title
    Reduction in tinnitus percept as assessed via the visual analog test of tinnitus loudness
    Description
    Measurement of the subjective loudness of the tinnitus percept is measured using the visual analog scale test after each intervention.
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lucas C Parra, Ph.D.
    Organizational Affiliation
    City College of New York, CUNY
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified data will be shared if requested

    Learn more about this trial

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

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