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

Last updated: April 11, 2025
Sponsor: University of Regensburg
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tinnitus

Treatment

lf-tRNS

Clinical Study ID

NCT02615600
Uni-Reg-tRNS02
  • Ages 18-70
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • diagnosis of bothersome, subjective chronic tinnitus

  • diagnosis: duration of tinnitus more than 6 months

Exclusion

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

  • clinically relevant 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

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: lf-tRNS
Phase:
Study Start date:
November 01, 2015
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • University of Regensburg - Deptartment of Psychiatry

    Regensburg, 93053
    Germany

    Active - Recruiting

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