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

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648542
• Other study ID #: CASTDCS001
• Status: Completed
• Phase: N/A
• First received: December 30, 2015
• Last updated: January 5, 2016
• Start date: March 2013
• Est. completion date: July 2014

Study information

• Verified date: January 2016
• Source: Soterix Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Other:
• Compensatory auditory stimulation
Compensating for peripheral hearing loss by adjusting sound levels based on individual audiogram.

Device:
• transcranial direct current stimulation
Low-current electrical brain stimulation

Other:
• Combined CAS and tDCS
Combined auditory and electrical stimulation
• Sham stimulation
Sham stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soterix Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in minimum masking levels	Measurement of the minimum masking level required to mask the subjective tinnitus loudness is assessed after each intervention.	2 weeks	No
Primary	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.	2 weeks	No