Acoustic + Electrical Stimulation for Tinnitus

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Irvine

Must not be taking: Aspirin, Ibuprofen, Naproxen

Disqualifiers: Illicit drug use, Alcohol dependence, Psychosis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing if playing sounds through headphones or using small electrical currents in the ear can help people with tinnitus. It targets those whose tinnitus significantly affects their quality of life. The treatment works by trying to interfere with the ringing noise, making it quieter or stopping it. Using small electrical currents has been explored in various studies as a potential treatment for tinnitus, showing mixed results in terms of effectiveness.

Do I need to stop taking my current medications for the trial?

If you are taking medications known to cause tinnitus, like aspirin, ibuprofen, or naproxen, you must be able to stop them to participate in the trial. Otherwise, the protocol does not specify if you need to stop other medications.

What data supports the effectiveness of the treatment Acoustic + Electrical Stimulation for Tinnitus?

Research shows that transcutaneous electrical stimulation (TENS) can help reduce tinnitus symptoms in some patients, with about half experiencing improvement and a third seeing substantial benefits. This suggests that the combination of acoustic and electrical stimulation might also be effective for tinnitus relief.

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Is acoustic and electrical stimulation therapy safe for humans?

Research indicates that electrical stimulation for tinnitus is generally safe when used within recommended guidelines, although a small number of patients may experience temporary or permanent increases in tinnitus.

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How does the Acoustic + Electrical Stimulation treatment for tinnitus differ from other treatments?

The Acoustic + Electrical Stimulation treatment for tinnitus is unique because it combines sound therapy with transcutaneous electrical nerve stimulation (TENS), which involves sending mild electrical currents through the skin to help reduce tinnitus symptoms. This approach is different from other treatments as it targets both auditory and nerve pathways, potentially offering relief for patients with specific types of tinnitus, such as those with low-frequency tinnitus and mild hearing loss.

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Eligibility Criteria

This trial is for adults who have had tinnitus, or ringing in the ears, for at least six months. Participants must speak English well enough to describe their experiences and complete surveys. Those with cochlear implants can join the electrical stimulation part of the study. Excluded are individuals under 18, pregnant or breastfeeding women, those on certain medications like aspirin that cause tinnitus, with ear abnormalities or treatable causes of tinnitus.

Inclusion Criteria

To be able to accurately describe the unusual sensations caused by electrical stimulation, and to be able to complete surveys about them.

I am 18 years old or older.

I am either male or female.

Exclusion Criteria

I have issues with my ear canal or ear drum.

I have a long-term ear infection.

My tinnitus can be treated.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo acoustic and electrical stimulation to evaluate tinnitus suppression

12 months

Multiple visits throughout the year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study investigates acoustic and electrical stimulation as treatments for tinnitus. Acoustic tests involve listening to sounds through headphones and rating tinnitus loudness. Electrical tests use a cochlear implant or electrodes placed in/on the ear to assess changes in tinnitus perception.

Group I: Electrical/ Acoustic stimulation Experimental Treatment 2 Interventions

Acoustic is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Electrical Stimulation Therapy for:

• Tinnitus suppression
• Tinnitus management

🇪🇺 Approved in European Union as Electrical Stimulation Therapy for:

• Tinnitus treatment
• Tinnitus relief

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Hamid R. Djalilian Irvine, CA

Who Is Running the Clinical Trial?

University of California, Irvine Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Treatment of tinnitus with electrical stimulation. [2017] The purpose of this study was to evaluate the treatment of tinnitus with electrical stimulation. Five hundred patients with tinnitus were treated with probe electrical stimulation. Causes of tinnitus were sensorineural hearing loss (303 patients), Meniere's disease (88), infection (25), head trauma (39), acoustic trauma (25), ototoxicity (4), and chemotherapy (2). Treatment involved 6 to 10 transcutaneous treatment electrical stimulation sessions biweekly. Fifty-three percent of patients showed decreases in their tinnitus as measured by a subjective rating scale. With a 3-month follow-up, 72% had no loss of benefit. Thirteen patients had temporary increases in their tinnitus. Two patients had permanent increases. Probe electrical stimulation seems to offer some benefit in about half the patients treated for annoying tinnitus.

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of transcutaneous electrical stimulation for chronic tinnitus. [2022] Based on the Tinnitus Handicap Inventory (THI) and visual analog scale (VAS) scores, transcutaneous electrical stimulation (TENS) can provide relief from tinnitus. Response to electrical stimulation was best seen in patients with low-frequency tinnitus and with mild hearing loss.

3. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrotherapy for severe tinnitus. [2019] In about a third of cases of severe tinnitus, transcutaneous stimulation for a few minutes by means of electric square waves gives substantial improvement. This very simple treatment must be repeated two or three times to achieve success. If an obvious improvement is not obtained after two or three attempts, failure must be considered as certain. The parameters of these stimulations are described and clinical results are reported. The mechanism of the improvement is uncertain.

4. France pubmed.ncbi.nlm.nih.gov

[Treatment of tinnitus by mean of electric transcutaneous stimulation (author's transl)]. [2006] In about a third of cases transcutaneous stimulation during a few minute by mean of electric square waves substantially improves severe tinnitus. This very simple treatment must be frequently repeated two or three times to be successful. If a notable improvement is not obtained after two or three attempts, failure must be considered as certain. The parameters of these stimulation are described and clinical results are reported. The mechanism of these improvement is uncertain.

5. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation for Treatment of Tinnitus: A Systematic Review and Meta-analysis. [2021] To evaluate the treatment efficacy of transcutaneous electrical nerve stimulation (TENS) in patients with tinnitus.

6. United States pubmed.ncbi.nlm.nih.gov

Tinnitus reduction using transcutaneous electrical stimulation. [2019] Electrical stimulation as a treatment for tinnitus seems to be effective in about 50% of patients with tinnitus of various causes. Electrical stimulation as a treatment for tinnitus is safe, if delivered within the parameters described in this article.

7. United States pubmed.ncbi.nlm.nih.gov

The effect of transcutaneous electrical nerve stimulation (TENS) on chronic subjective tinnitus. [2020] Chronic Subjective Tinnitus is a very highly prevalent disorder worldwide. There is no definitive treatment. The aim of this study is to investigate the efficacy of transcutaneous electrical nerve stimulation (TENS) applied to the auricula for treating tinnitus using the Depression Anxiety Stress Scales (DASS) and Tinnitus Handicap Inventory (THI).

8. England pubmed.ncbi.nlm.nih.gov

Treatment of tinnitus with transcutaneous electrical nerve stimulation improves patients' quality of life. [2008] Tinnitus can adversely affect patients' quality of life. Transcutaneous electrical nerve stimulation (TENS) may be effective in the management of tinnitus. No study has investigated the efficacy of TENS for the management of tinnitus by means of quality of life measures. In this study, we evaluated the efficacy of TENS for the management of tinnitus symptoms by using the visual analogue scale (VAS), tinnitus handicap inventory test, Nottingham health profile (NHP) and short form-36 (SF-36) questionnaires.

9. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Electric Nerve Stimulation in Chronic Subjective Tinnitus. [2022] It is aimed to determine the therapeutic role of transcutaneous electrical nerve stimulation (TENS) on chronic subjective tinnitus with a randomized and comparative analysis.

10. United States pubmed.ncbi.nlm.nih.gov

External electrical tinnitus suppression: a review. [2006] Our experience with transcutaneous electrical stimulation for tinnitus suppression has been with the Theraband Headset from Audimax Inc. The purpose of this article is to review the highlights of the patients who exhibited tinnitus suppression and/or tinnitus control, and to provide an update of our results and techniques using external electrical stimulation with prolonged stimulation (stage IV). Patient selection is considered critical to the success of external electrical stimulation for tinnitus suppression. The key elements include the clinical finding of a peripheral site of lesion of the tinnitus; positive maskability of the symptom of tinnitus; absence of active ear disease; absence of a vestibular asymmetry; and absence or minimal evidence of dysfunction of the central auditory system. The protocol described for patient selection allows for tinnitus identification, the differentiation of clinical tinnitus types, and the clinical application of the concept of the dynamic range of electrical tinnitus suppression. External electrical tinnitus suppression is believed effective in a limited number of patients clinically identified as having a tinnitus site of lesion primarily peripheral in location and cochlear in type. The present device is not commercially available at this time. Both specific and general suggestions are proposed for the standardization of methods of reporting results of electrical tinnitus suppression and tinnitus control.