Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02648542
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Soterix Medical

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.

Condition or disease Intervention/treatment Phase
Tinnitus Other: Compensatory auditory stimulation Device: transcranial direct current stimulation Other: Combined CAS and tDCS Other: Sham stimulation Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of Compensatory Auditory Stimulation and Transcranial Direct Current Stimulation on Tinnitus Perception
Study Start Date : March 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Active Comparator: CAS vs. tDCS
Assess the efficacy of compensatory auditory stimulation (CAS) versus transcranial direct current stimulation (tDCS)
Other: Compensatory auditory stimulation
Compensating for peripheral hearing loss by adjusting sound levels based on individual audiogram.
Other Name: CAS

Device: transcranial direct current stimulation
Low-current electrical brain stimulation
Other Name: tDCS

Sham Comparator: Combined CAS+tDCS vs. Sham
Assess the efficacy of combined compensatory auditory stimulation (CAS) + transcranial direct current stimulation (tDCS) versus sham stimulation
Other: Combined CAS and tDCS
Combined auditory and electrical stimulation
Other Name: CAS + tDCS

Other: Sham stimulation
Sham stimulation
Other Name: Sham




Primary Outcome Measures :
  1. Reduction in minimum masking levels [ Time Frame: 2 weeks ]
    Measurement of the minimum masking level required to mask the subjective tinnitus loudness is assessed after each intervention.

  2. Reduction in tinnitus percept as assessed via the visual analog test of tinnitus loudness [ Time Frame: 2 weeks ]
    Measurement of the subjective loudness of the tinnitus percept is measured using the visual analog scale test after each intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648542


Sponsors and Collaborators
Soterix Medical
Investigators
Layout table for investigator information
Principal Investigator: Lucas C Parra, Ph.D. City College of New York, CUNY

Layout table for additonal information
Responsible Party: Soterix Medical
ClinicalTrials.gov Identifier: NCT02648542     History of Changes
Other Study ID Numbers: CASTDCS001
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared if requested

Additional relevant MeSH terms:
Layout table for MeSH terms
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms