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
About this trial
This is an interventional treatment trial for Tinnitus
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)
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
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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