ClinicalTrials.gg
CompletedNCT02615600Updated Jun 15, 2026

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

An interventional study of lf-tRNS in Chronic Tinnitus, sponsored by University of Regensburg. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by University of Regensburg · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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Study 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 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.

02

Conditions studied

  • Chronic Tinnitus

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Keywords

  • tinnitus
  • transcranial random noise stimulation
  • tRNS
  • auditory cortex
  • non-invasive brain stimulation
03

In context

Tinnitus

444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 368 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

University of Regensburg is the lead sponsor of 71 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • diagnosis of bothersome, subjective chronic tinnitus
  • diagnosis: duration of tinnitus more than 6 months

Exclusion criteria

Exclusion criteria:

  • 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
  • psychiatric comorbidity
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    lf-tRNS

    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

    Device: lf-tRNS

Interventions

  • Devicelf-tRNS

    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

06

What researchers measure

Primary outcomes

  1. number of treatment responders

    response: tinnitus questionnaire total score reduction of at least 5 points, contrast baseline versus end of treatment (week 12)

    Time frame: week 12

Secondary outcomes

  1. change in tinnitus questionnaire

    change in tinnitus questionnaire

    Time frame: week 2, week 4, week 12

  2. change in tinnitus handicap inventory

    change in tinnitus handicap inventory

    Time frame: week 2, week 4, week 12

  3. change in tinnitus numeric rating scales

    change in tinnitus numeric rating scales

    Time frame: week 2, week 4, week 12

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Study locations

1 site
  • University of Regensburg - Deptartment of Psychiatry
    Regensburg, 93053, Germany
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2015 to primary completion in Apr 2021, 65 months.

Of 133 non-industry interventional studies with no phase under Tinnitus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 65 months is above that.

Counting every sponsor, half of 151 studies reached it within 17 months; a quarter within 10 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 24, 2015
First posted
Nov 26, 2015
StartActual
Nov 2015
Primary completionActual
Apr 6, 2021
CompletionActual
Dec 31, 2021
Last update
Jun 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02615600
Lead sponsor
University of Regensburg
Responsible party
Berthold Langguth, MD, Ph.D. (M.D., Ph.D., University of Regensburg) — Principal investigator
First posted
Nov 26, 2015
Start date
Nov 2015
Primary completion
Apr 6, 2021
Completion
Dec 31, 2021
Last update
Jun 15, 2026

Study contacts

Berthold Langguth
principal investigator · University of Regensburg

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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