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

Not Applicable

Completed

• Conditions: Tinnitus
• Interventions: Other: Compensatory auditory stimulation; Other: Combined CAS and tDCS; Other: Sham stimulation; Device: transcranial direct current stimulation

• Registration Number: NCT02648542
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2015-12-30
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Combined CAS+tDCS vs. Sham	Sham stimulation	Assess the efficacy of combined compensatory auditory stimulation (CAS) + transcranial direct current stimulation (tDCS) versus sham stimulation
CAS vs. tDCS	transcranial direct current stimulation	Assess the efficacy of compensatory auditory stimulation (CAS) versus transcranial direct current stimulation (tDCS)
CAS vs. tDCS	Compensatory auditory stimulation	Assess the efficacy of compensatory auditory stimulation (CAS) versus transcranial direct current stimulation (tDCS)
Combined CAS+tDCS vs. Sham	Combined CAS and tDCS	Assess the efficacy of combined compensatory auditory stimulation (CAS) + transcranial direct current stimulation (tDCS) versus sham stimulation

Primary Outcome Measures

Name	Time	Method
Reduction in minimum masking levels	2 weeks	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	2 weeks	Measurement of the subjective loudness of the tinnitus percept is measured using the visual analog scale test after each intervention.