Skip to main content
OpenTrials
Completed

NCT Number: NCT01965028

Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus

Stimulation of the left and right auditory cortex with daily transcranial random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Regensburg - Dept of Psychiatry

Regensburg, Germany

About this study

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. Preliminary data presented on international conferences suggest the use of transcranial random noise stimulation (tRNS) over both auditory cortices as new and highly effective treatment. High-frequency (hf; 100-650Hz) tRNS might be highly effective in tackling hyper-synchronised cell assemblies. Daily Hf-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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of bothersome, subjective chronic tinnitus
  • Diagnosis: Duration of tinnitus more than 6 months

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

Treatment and study plan

transcranial random noise stimulation (tRNS)

Device

High frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): 100-650Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 Arms: tRNS

Primary outcomes

  1. Number of treatment responders (response: Tinnitus Questionnaire total score reduction ≥ 5, contrast baseline versus end of treatment/week 12)

    Time frame: Week 12

Secondary outcomes

  1. Change of tinnitus severity as measured by the Tinnitus Questionnaire

    Time frame: Week 2

  2. Change of tinnitus severity as measured by the Tinnitus Questionnaire

    Time frame: Week 4

  3. Change of tinnitus severity as measured by the Tinnitus Questionnaire

    Time frame: Week 12

  4. Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales

    Time frame: Week 2

  5. Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales

    Time frame: Week 4

  6. Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales

    Time frame: Week 12

  7. Change of depressive symptoms as measured by the Major Depression Inventory

    Time frame: Week 2

  8. Change of depressive symptoms as measured by the Major Depression Inventory

    Time frame: Week 4

  9. Change of depressive symptoms as measured by the Major Depression Inventory

    Time frame: Week 12

  10. Change in quality of life as measured by the WHOQoL-Bref

    Time frame: Week 2

  11. Change in quality of life as measured by the WHOQoL-Bref

    Time frame: Week 4

  12. Change in quality of life as measured by the WHOQoL-Bref

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

Effectiveness of Daily Bi-temporal Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus

Acronym: tRNS-tin

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 18, 2013
Registry last updated
Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.