Chronic TinnitusNCT02615600
Daily Bitemporal Low-frequency Transcranial Random Noise Stimulation in Tinnitus (tRNS2-tin)
A study testing lf-tRNS in people with Chronic Tinnitus, run by University of Regensburg at 1 site in Germany.
Trial summary
Stimulation of the left and right auditory cortex with daily low-frequency transcranial random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Tinnitus
- What is being tested?
- lf-tRNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of bothersome, subjective chronic tinnitus
- diagnosis: duration of tinnitus more than 6 months
Who cannot join
- objective tinnitus
- irregular head shap below the electrodes
- eczema on the head
- treatable cause of the tinnitus
- involvement in other treatments for tinnitus at the same time
- clinically relevant psychiatric comorbidity
Show all 13Show fewer
- clinically relevant unstable internal or neurological comorbidity
- history of or evidence of significant brain malformation or neoplasm, head injury
- cerebral vascular events
- neurodegenerative disorder affecting the brain or prior brain surgery
- metal objects in and around body that can not be removed
- pregnancy
- alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Regensburg - Deptartment of Psychiatry
Regensburg, 93053
About this study
Official title: Effectiveness of Daily Bitemporal Low-frequency Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus
Stimulation of the left and right auditory cortex with daily low-frequency transcranial random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.
Read the detailed description
Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. These changes are represented by hyper-activity and hyper-synchronicity in the auditory pathway. Treatment remains difficult. Non-invasive brain stimulation methods has shown to be effective in the treatment of chronic tinnitus with moderate effect size. First data suggest the use of transcranial random noise stimulation (tRNS) over both auditory cortices as new and highly effective treatment. Low-frequency (lf; <100Hz) tRNS might be highly effective in tackling hyper-synchronised cell assemblies. Daily lf-tRNS (2 weeks) will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in an one-arm pilot trial.
- Conditions
- Chronic Tinnitus
- Being tested
- lf-tRNS
- Keywords
- tinnitus, transcranial random noise stimulation, tRNS, auditory cortex, non-invasive brain stimulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lf-tRNSDevice
Low-frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): <100Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4
| Study group | Role | What they receive |
|---|---|---|
| lf-tRNS | Experimental | Low-frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): <100Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 Receives: Device: lf-tRNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of treatment responders
response: tinnitus questionnaire total score reduction of at least 5 points, contrast baseline versus end of treatment (week 12)
Measured: week 12
Secondary outcomes (3)
change in tinnitus questionnaire
change in tinnitus questionnaire
Measured: week 2, week 4, week 12
change in tinnitus handicap inventory
change in tinnitus handicap inventory
Measured: week 2, week 4, week 12
change in tinnitus numeric rating scales
change in tinnitus numeric rating scales
Measured: week 2, week 4, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion6 Apr 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berthold Langguth, MD, Ph.D., University of Regensburg
- Investigators
- Berthold Langguth, Principal investigator, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615600
- Sponsor's protocol ID
- Uni-Reg-tRNS02
- Status last verified
- Sep 2025
- First submitted
- 24 Nov 2015
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Daily Bitemporal Low-frequency Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT02615600
- Acronym / sponsor ID
- Uni-Reg-tRNS02
- Conditions
- Chronic Tinnitus
- Keywords
- tinnitus, transcranial random noise stimulation, tRNS, auditory cortex, non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stimulation of the left and right auditory cortex with daily low-frequency transcranial random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.
Detailed description
Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. These changes are represented by hyper-activity and hyper-synchronicity in the auditory pathway. Treatment remains difficult. Non-invasive brain stimulation methods has shown to be effective in the treatment of chronic tinnitus with moderate effect size. First data suggest the use of transcranial random noise stimulation (tRNS) over both auditory cortices as new and highly effective treatment. Low-frequency (lf; <100Hz) tRNS might be highly effective in tackling hyper-synchronised cell assemblies. Daily lf-tRNS (2 weeks) will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in an one-arm pilot trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lf-tRNS | Experimental | Device: lf-tRNSLow-frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): <100Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of bothersome, subjective chronic tinnitus
- diagnosis: duration of tinnitus more than 6 months
Key exclusion criteria (13 listed)
- objective tinnitus
- irregular head shap below the electrodes
- eczema on the head
- treatable cause of the tinnitus
- involvement in other treatments for tinnitus at the same time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lf-tRNSLow-frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): <100Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 | Device | lf-tRNS |
Primary outcome
number of treatment responders
Time frame: week 12
response: tinnitus questionnaire total score reduction of at least 5 points, contrast baseline versus end of treatment (week 12)
3 secondary outcomes
change in tinnitus questionnaire
Time frame: week 2, week 4, week 12
change in tinnitus handicap inventory
Time frame: week 2, week 4, week 12
change in tinnitus numeric rating scales
Time frame: week 2, week 4, week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold Langguth principal investigator
University of Regensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lf-tRNS in people with Chronic Tinnitus, run by University of Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of treatment responders (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.