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

Primary Purpose

Chronic Tinnitus

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
lf-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 - Deptartment of PsychiatryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lf-tRNS

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

change in tinnitus questionnaire
change in tinnitus questionnaire
change in tinnitus handicap inventory
change in tinnitus handicap inventory
change in tinnitus numeric rating scales
change in tinnitus numeric rating scales

Full Information

First Posted
November 24, 2015
Last Updated
December 8, 2022
Sponsor
University of Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT02615600
Brief Title
Daily Bitemporal Low-frequency Transcranial Random Noise Stimulation in Tinnitus (tRNS2-tin)
Official Title
Effectiveness of Daily Bitemporal Low-frequency Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

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 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lf-tRNS
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
lf-tRNS
Intervention Description
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
Primary Outcome Measure Information:
Title
number of treatment responders
Description
response: tinnitus questionnaire total score reduction of at least 5 points, contrast baseline versus end of treatment (week 12)
Time Frame
week 12
Secondary Outcome Measure Information:
Title
change in tinnitus questionnaire
Description
change in tinnitus questionnaire
Time Frame
week 2, week 4, week 12
Title
change in tinnitus handicap inventory
Description
change in tinnitus handicap inventory
Time Frame
week 2, week 4, week 12
Title
change in tinnitus numeric rating scales
Description
change in tinnitus numeric rating scales
Time Frame
week 2, week 4, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Berthold Langguth
Email
berthold.langguth@medbo.de
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Schecklmann
Email
martin.schecklmann@medbo.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth
Organizational Affiliation
University of Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regensburg - Deptartment of Psychiatry
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Schecklmann, Dr.
Phone
+49 941 941
Ext
2054
Email
martin.schecklmann@medbo.de
First Name & Middle Initial & Last Name & Degree
Berthold Langguth, MD, Ph.D.
First Name & Middle Initial & Last Name & Degree
Peter Kreuzer, MD, Dr.
First Name & Middle Initial & Last Name & Degree
Timm Pöppl, MD, Dr.
First Name & Middle Initial & Last Name & Degree
Martin Schecklmann, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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