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Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus (tRNS-tin)

Primary Purpose

Chronic Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transcranial random noise stimulation (tRNS)
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Tinnitus focused on measuring tinnitus, transcranial random noise stimulation, tRNS, auditory cortex, non-invasive brain stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Regensburg - Dept of Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial random noise stimulation (tRNS)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of tinnitus severity as measured by the Tinnitus Questionnaire
Change of tinnitus severity as measured by the Tinnitus Questionnaire
Change of tinnitus severity as measured by the Tinnitus Questionnaire
Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Change of depressive symptoms as measured by the Major Depression Inventory
Change of depressive symptoms as measured by the Major Depression Inventory
Change of depressive symptoms as measured by the Major Depression Inventory
Change in quality of life as measured by the WHOQoL-Bref
Change in quality of life as measured by the WHOQoL-Bref
Change in quality of life as measured by the WHOQoL-Bref

Full Information

First Posted
October 14, 2013
Last Updated
March 4, 2016
Sponsor
University of Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT01965028
Brief Title
Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus
Acronym
tRNS-tin
Official Title
Effectiveness of Daily Bi-temporal Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg

4. Oversight

5. Study Description

Brief Summary
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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tinnitus
Keywords
tinnitus, transcranial random noise stimulation, tRNS, auditory cortex, non-invasive brain stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial random noise stimulation (tRNS)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transcranial random noise stimulation (tRNS)
Intervention Description
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 Outcome Measure Information:
Title
Number of treatment responders (response: Tinnitus Questionnaire total score reduction ≥ 5, contrast baseline versus end of treatment/week 12)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change of tinnitus severity as measured by the Tinnitus Questionnaire
Time Frame
Week 2
Title
Change of tinnitus severity as measured by the Tinnitus Questionnaire
Time Frame
Week 4
Title
Change of tinnitus severity as measured by the Tinnitus Questionnaire
Time Frame
Week 12
Title
Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Time Frame
Week 2
Title
Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Time Frame
Week 4
Title
Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Time Frame
Week 12
Title
Change of depressive symptoms as measured by the Major Depression Inventory
Time Frame
Week 2
Title
Change of depressive symptoms as measured by the Major Depression Inventory
Time Frame
Week 4
Title
Change of depressive symptoms as measured by the Major Depression Inventory
Time Frame
Week 12
Title
Change in quality of life as measured by the WHOQoL-Bref
Time Frame
Week 2
Title
Change in quality of life as measured by the WHOQoL-Bref
Time Frame
Week 4
Title
Change in quality of life as measured by the WHOQoL-Bref
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth, MD, Ph.D.
Organizational Affiliation
University of Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regensburg - Dept of Psychiatry
City
Regensburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
31439873
Citation
Kreuzer PM, Poeppl TB, Rupprecht R, Vielsmeier V, Lehner A, Langguth B, Schecklmann M. Daily high-frequency transcranial random noise stimulation of bilateral temporal cortex in chronic tinnitus - a pilot study. Sci Rep. 2019 Aug 22;9(1):12274. doi: 10.1038/s41598-019-48686-0.
Results Reference
derived

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Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus

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