Acoustic and Electrical Stimulation for the Treatment of Tinnitus

NCT03511807 | Active Not Recruiting

• 1 other identifier: 20065187
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Tinnitus, or ringing in the ears, affects 10% to 30% of the population. Of those, 20% have tinnitus bothersome enough to seek medical attention. In many people, tinnitus can significantly affect the quality of life. At this point in time, there is no effective treatment or cure available for tinnitus. It has been found that electrical stimulation of the inner ear can reduce and in some cases eliminate tinnitus. The purpose of this research is to investigate both acoustic and electrical stimulation of the inner ear as a possible treatment of tinnitus. In both acoustic and electrical testing conditions, the subjects will be instructed to be familiar with a 0-10 ranking scale of loudness. In acoustic testing, the stimulus will be presented through headphones in a noiseless environment, and the subject will be asked to report on the loudness of the presented sound and the level of the tinnitus at 20-second intervals. If the subject cannot perceive the presence of the tinnitus, a value of zero will be assigned. A typical sound will be presented for 3 to 6 minutes. Loudness will be reported for 1 to 4 minutes after stimulus offset to measure the presence and duration of residual inhibition. Electrical stimulation will be delivered to the inner ear in three ways, 1. using a cochlear implant (implant placed in the inner ear to replace hearing function), 2. Using an electrode placed in the ear canal, and 3. using a small needle inserted through the ear drum. Various electrical signals will be used to evaluate the reduction in the tinnitus perception by the subject. The subjects will rate the loudness of the tinnitus before, during, and after the electrical signal. Surveys will be used to evaluate the tinnitus loudness and the quality of life of the subjects. Hearing tests will be used before and after the procedures. The long term goal of this research is to develop a device to treat tinnitus in people who can hear and to develop programs for cochlear implants that help treat tinnitus in deaf people.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (4)

• Audiogram

  Measures hearing ability in db hearing loss (HL).

  Occurs once at the beginning of subject participation (less than one hour)

• Otoacoustic Emissions (OAE)

  Measures health of the inner ear in db hearing loss (HL).

  Occurs once at the beginning of subject participation (less than one hour)

• Tinnitus Handicap Inventory (THI)

  Quantifies and evaluates difficulties experience because of tinnitus measured in a numerical score range: Yes (value of 4, highest) Sometimes (value of 2) and No (value of 0, lowest). The sum of all responses yields a total THI score (0-100). High scores indicate catastrophic handicap. Low scores indicate slight or no handicap.

  Outcome will be measured during each participant visit through study completion which can be an average of 1 year

• Medical Outcomes Study Questionnaire Short Form 36 (SF-36) Health Survey Quality of life metrics.

  The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores indicate more disability, higher scores indicate less disability.

  Outcome will be measured during each participant visit through study completion which can be an average of 1 year

Study Arms (1)

Electrical/ Acoustic stimulation

EXPERIMENTAL

Other: Electrical; Other: Acoustic

Interventions

Electrical OTHER

For the electrical stimulation: An electrode will be inserted into the ear canal which will be stimulated.

Electrical/ Acoustic stimulation

Acoustic OTHER

For the acoustic stimulation: A typical sound will be presented for 6 minutes. Loudness is reported for 4 minutes after the stimulus offset to measure the presence and duration of the residual inhibition. If a successful acoustic stimulus is found, the subject will be given a series of sound files to listen to on a digital music player (CD or MP3 player) and will be asked to listen to each sound file (5 minute duration) and record their tinnitus loudness/annoyance during and after each sound stimulation. For some subjects, the investigators will use music on a digital music player (MP3 player) to see if music listening and music exercises will help reduce the intensity or annoyance level of the tinnitus (using the same surveys). These music-based exercises will involve training in recognition of musical intervals (e.g., octaves, fifths, and thirds).

Electrical/ Acoustic stimulation

Eligibility Criteria

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

You may qualify if:

• years or older
• Male or female
• Tinnitus present for 6 months or more
• Adequate command of English to reliably describe the unusual sensory percepts provided by electrical stimulation, and to complete surveys.
• For patients undergoing electrical stimulation via a cochlear implant, they should have a cochlear implant prior to enrollment (not applicable for acoustic stimulation)

You may not qualify if:

• Aged less than 18 years
• Active illicit drug use, alcohol dependence
• Treatable cause of tinnitus
• History of psychosis
• Abnormalities of the ear canal or ear drum
• Chronic middle ear disease
• Subjects on medications known to cause tinnitus (aspirin, ibuprofen, naproxen) which could not be stopped will be excluded.
• Pregnant or breastfeeding.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Hamid R. Djalilian

Irvine, California, 92612, United States

Location

Related Publications (12)

• Feldman H. History of tinnitus research. In: Shulman A, ed. Tinnitus Diagnosis/Treatment. San Diego: Singular Publishing Group; 1997:3-37.

  BACKGROUND

• de Sauvage RC, Cazals Y, Aran JM. Observation of an electrically evoked whole-nerve response using the same stimulating and recording electrode: an image of the unit response at the round window (preliminary report). Hear Res. 1980 Jun;2(3-4):343-6. doi: 10.1016/0378-5955(80)90068-4. No abstract available.

  PMID: 7410238 BACKGROUND

• Zwolan TA, Kileny PR, Souliere CR, Kemink JL. Tinnitus suppression following cochlear implantation. In: Aran J-M, Dauman R, eds. Tinnitus 91: Proceedings of the Fourth International Tinnitus Seminar. Amsterdam: Kugler, 1992;423-6.

  BACKGROUND

• Rubinstein JT, Tyler RS, Johnson A, Brown CJ. Electrical suppression of tinnitus with high-rate pulse trains. Otol Neurotol. 2003 May;24(3):478-85. doi: 10.1097/00129492-200305000-00021.

  PMID: 12806303 BACKGROUND

• Kuk FK, Tyler RS, Rustad N, Harker LA, Tye-Murray N. Alternating current at the eardrum for tinnitus reduction. J Speech Hear Res. 1989 Jun;32(2):393-400. doi: 10.1044/jshr.3202.393.

  PMID: 2786979 BACKGROUND

• Hazell JW, Jastreboff PJ, Meerton LE, Conway MJ. Electrical tinnitus suppression: frequency dependence of effects. Audiology. 1993;32(1):68-77. doi: 10.3109/00206099309072929.

  PMID: 8447763 BACKGROUND

• Okusa M, Shiraishi T, Kubo T, Matsunaga T. Tinnitus suppression by electrical promontory stimulation in sensorineural deaf patients. Acta Otolaryngol Suppl. 1993;501:54-8. doi: 10.3109/00016489309126215.

  PMID: 8447227 BACKGROUND

• Ito J, Sakakihara J. Tinnitus suppression by electrical stimulation of the cochlear wall and by cochlear implantation. Laryngoscope. 1994 Jun;104(6 Pt 1):752-4. doi: 10.1288/00005537-199406000-00017.

  PMID: 8196452 BACKGROUND

• Matsushima JI, Sakai N, Uemi N, Miyoshi S, Sakajiri M, Ifukube T. Evaluation of Implanted Tinnitus Suppressor Based on Tinnitus Stress Test. Int Tinnitus J. 1997;3(2):123-131.

  PMID: 10753374 BACKGROUND

• Shulman A. External electrical stimulation in tinnitus control. Am J Otol. 1985 Jan;6(1):110-5. No abstract available.

  PMID: 3872077 BACKGROUND

• Vurek LS, White M, Fong M, Walsh SM. Opto-isolated stimulators used for electrically evoked BSER: some observations on electrical artifact. Ann Otol Rhinol Laryngol Suppl. 1981 Mar-Apr;90(2 Pt 3):21-4. doi: 10.1177/00034894810902s208. No abstract available.

  PMID: 6784647 BACKGROUND

• Zeng FG, Shannon RV. Loudness-coding mechanisms inferred from electric stimulation of the human auditory system. Science. 1994 Apr 22;264(5158):564-6. doi: 10.1126/science.8160013.

  PMID: 8160013 BACKGROUND

MeSH Terms

Conditions

Tinnitus

Interventions

Electricity

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)

Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Otolaryngology

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: April 30, 2018
• Study Start: January 1, 2017
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)