RecruitingNAINTERVENTIONAL

Daily Bitemporal Low-frequency Transcranial Random Noise Stimulation in Tinnitus (tRNS2-tin)

This study is investigating a new treatment for chronic tinnitus, which is a persistent ringing or buzzing sound in the ears that isn't caused by an outside noise. The treatment is called low-frequency transcranial random noise stimulation (lf-tRNS). It involves applying very gentle, undetectable electrical pulses to specific areas on the head over the left and right auditory cortex, which are parts of the brain involved in hearing. The aim is to see if these pulses can help to quiet down the overactive brain pathways that are thought to cause tinnitus. This is an early pilot study lasting two weeks, focused on seeing if the treatment is safe, practical, and shows promise for reducing tinnitus symptoms in people aged 18 to 70.

At a glance

Status

Recruiting

Phase

Sponsor

University of Regensburg

Enrolment target

Start

01 Nov 2015

Estimated completion

31 Dec 2025

Chronic Tinnitus

What is this study about?

Tinnitus is when you hear sounds like ringing, buzzing, or hissing when there's no actual sound around you. It's a common problem that can really affect your daily life. While we don't fully understand it, we know that tinnitus often starts in the brain, where the parts responsible for hearing become overactive or out of sync. This can make it hard to find effective treatments.

This study is exploring a new approach called low-frequency transcranial random noise stimulation (lf-tRNS). This treatment involves placing small patches on your head over the areas of your brain that process sound. These patches deliver very gentle, low-level electrical signals to these brain regions. The idea is that these gentle pulses might help to calm down the overactivity in the brain that contributes to tinnitus.

We're trying to see if this treatment can be a helpful new option for people with chronic tinnitus. This early study will help us understand if it's safe, easy to use, and if it shows encouraging results in reducing tinnitus symptoms. If it does, it could open the door for larger studies in the future.

Key takeaways

This is a pilot study testing a new, gentle electrical brain stimulation for chronic tinnitus.
The treatment involves daily sessions over two weeks.
It aims to calm overactive brain areas linked to tinnitus.
It's for people aged 18-70 with bothersome tinnitus for over 6 months.
Your safety and comfort are top priorities, and you can withdraw at any time.

Who may be eligible?

This study is looking for volunteers between 18 and 70 years old who have been diagnosed with bothersome, ongoing tinnitus for more than six months. This means your tinnitus should be something that genuinely affects your life and isn't just a temporary annoyance.

There are several reasons why someone might not be able to join. For example, if your tinnitus is caused by a specific, treatable medical problem, or if you have certain skin conditions on your head that would prevent the treatment, you wouldn't be able to participate. We also can't include people who are already undergoing other tinnitus treatments at the same time, or those with significant other health conditions like serious heart, brain, or mental health issues. If you have any metal objects in your body that can't be removed, or if you've had certain brain surgeries or conditions, you also wouldn't be eligible.

We also can't include pregnant individuals, or those with a history of alcohol or drug abuse. These rules are in place to ensure the safety of everyone taking part and to make sure the study results are clear and accurate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Have you had bothering tinnitus for more than six months?
Is your head shape regular and do you have healthy skin where the patches would go?
Are you NOT currently being treated for tinnitus with other methods?
Do you NOT have any significant other medical conditions like severe heart or brain problems?
Are you NOT pregnant and do you NOT have any metal items in your body that can't be removed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the gentle electrical stimulation treatment every day for two weeks. This treatment involves wearing small patches on your head for a period each day during your visits to the study site. We would regularly check on how you're feeling and how your tinnitus is responding to the treatment.

Throughout the study, we would ask you to complete questionnaires and assessments to help us understand if the treatment is helpful and how it affects your tinnitus. All appointments would be scheduled at the study clinic. The total duration of your active involvement in the study would be approximately two weeks.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For this study, potential benefits might include an improvement in your tinnitus symptoms, though this is not guaranteed as it's an early-stage investigation. You would also be contributing valuable information that could help develop new treatments for tinnitus in the future. Potential risks are generally considered low with this type of gentle electrical stimulation, but could include minor skin irritation where the patches are placed or temporary sensations during treatment. You will be monitored closely for any side effects. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of Regensburg - Deptartment of Psychiatry
Verified postcode
Regensburg, Germany· Recruiting

Common questions

What does 'chronic tinnitus' mean?

It means you've had ringing or other sounds in your ears for six months or longer, and it's bothering you.

What is 'low-frequency transcranial random noise stimulation'?

It's a way of sending very gentle electrical signals to specific parts of your brain using small patches on your head, aiming to help calm down overactive brain areas.

Will I feel the electrical stimulation?

The stimulation is very gentle and usually not felt, or only felt as a very mild tingle or sensation.

How long does the study treatment last?

The treatment period for this study involves daily sessions over two weeks.

Can I still take my regular medicines if I join?

It's very important to discuss all your current medications with the study team. Some medications or other treatments might mean you can't join.

How to find out more

Berthold Langguth

berthold.langguth@medbo.de Official trial record

Always speak to your GP or specialist before deciding to take part in a study.