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

NCT02648542 | Completed DMC

• 1 other identifier: CASTDCS001
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

CAS vs. tDCS

ACTIVE COMPARATOR

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

Other: Compensatory auditory stimulation; Device: transcranial direct current stimulation

Combined CAS+tDCS vs. Sham

SHAM COMPARATOR

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

Other: Combined CAS and tDCS; Other: Sham stimulation

Interventions

Compensatory auditory stimulation OTHER

Compensating for peripheral hearing loss by adjusting sound levels based on individual audiogram.

Also known as: CAS

CAS vs. tDCS

transcranial direct current stimulation DEVICE

Low-current electrical brain stimulation

Also known as: tDCS

CAS vs. tDCS

Combined CAS and tDCS OTHER

Combined auditory and electrical stimulation

Also known as: CAS + tDCS

Combined CAS+tDCS vs. Sham

Sham stimulation OTHER

Sham stimulation

Also known as: Sham

Combined CAS+tDCS vs. Sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18-80 years of age
• No history of otological disease
• Subjects with hearing loss, hyperacusis and/or tinnitus are eligible to participate

You may not qualify if:

• hearing loss greater than 50 dB HL
• Shows signs of depression or anxiety (Zung self-rating Depression Scale \> 50; Beck Anxiety Inventory \> 36)

Sponsors & Collaborators

• Soterix Medical: lead

MeSH Terms

Conditions

Tinnitus

Interventions

Transcranial Direct Current Stimulation; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Lucas C Parra, Ph.D.

  City College of New York, CUNY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 7, 2016
• Study Start: March 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share