Using electrical and acoustic stimulation to treat tinnitus
Transcranial Electrical and Acoustic Stimulation for Tinnitus: A Randomized Double Blind Clinical Trial
This study is testing whether a combination of electrical and sound treatments can help people with chronic tinnitus feel better compared to just using the electrical treatment alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT04551404 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcranial random noise stimulation (tRNS) combined with acoustic stimulation on patients suffering from chronic tinnitus. Participants will receive either the combined treatment or tRNS alone to assess improvements in tinnitus perception. The study aims to build on previous pilot studies that suggested enhanced outcomes when electrical and acoustic methods are used together. Eligible participants will be monitored over the course of the treatment to evaluate efficacy and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with persistent chronic tinnitus lasting more than three months.
Not a fit: Patients with neurological or psychiatric disorders, hyperacusis, or those on certain medications affecting the central nervous system may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce tinnitus symptoms for patients, improving their quality of life.
How similar studies have performed: Previous pilot studies have shown promising results with similar approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female patients 18 years to 75 years of age (younger age limit according to corona virus protection concepts and measures of the FOPH: Schutzkonzepte und -massnahmen (admin.ch)) * Persistent chronic tinnitus with duration of more than 3 months * Signed Informed Consent after being informed about the study * Fluent in German or English * Tinnitus with a THI Grade 2 to 4 (18-76 points) * Willing and able to attend the study visits Exclusion Criteria: * Actual neurological or psychiatric disorders * Hyperacusis * Regular intake of medication influencing the central nervous system (e.g. neuroleptics, hypnotics, sedatives, and anti-epileptics) * Implanted pacemaker * Surgical implants in the head region, such as cochlea implants * Asymmetrical hearing (more than 20dB side difference), pantonal hearing loss \> 40dB in any measured frequency up to 2kHz * Women who are pregnant or breast feeding * Intention to become pregnant during the course of the study * Known or suspected non-compliance, drug or alcohol abuse * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Enrolment of the investigator, his/her family members, employees and other dependent persons
Where this trial is running
Zurich
- University Hospital Zurich, University Zurich — Zurich, Switzerland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.