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Influence of Treatment Duration and Stimulation Frequency on rTMS in Chronic Tinnitus

Primary Purpose

Chronic Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
standard multisite four weeks
high-frequency multisite four weeks
standard multisite two weeks
high-frequency multisite two weeks
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, rTMS, multisite stimulation, non-invasive brain stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • written informed consent
  • duration of tinnitus more than 6 months
  • bothersome chronic tinnitus

Exclusion Criteria:

  • not stable internal, mental, and neurological diseases
  • contraindication for rTMS (pacemaker, metal implants, pregnancy, epilepsy, status post severe craniocerebral injury )
  • uninvolvement in other treatment studies for tinnitus at the same time

Sites / Locations

  • University of Regensburg- Dept of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

standard multisite four weeks

high-frequency multisite four weeks

standard multisite two weeks

high-frequency multisite two weeks

Arm Description

Combined high-frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation; complete treatment of four weeks

Combined high-frequency dorsolateral prefrontal (unilateral) and high-frequency temporoparietal (bilateral) stimulation; complete treatment of four weeks

Combined high-frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation; discontinuation after two weeks

Combined high-frequency dorsolateral prefrontal (unilateral) and high-frequency temporoparietal (bilateral) stimulation; discontinuation after two weeks

Outcomes

Primary Outcome Measures

change in tinnitus questionnaire
change in tinnitus questionnaire

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
change in major depression inventory
change in major depression inventory
change in clinical global impression
change in clinical global impression
change in quality of life
change in quality of life

Full Information

First Posted
January 8, 2016
Last Updated
June 14, 2018
Sponsor
University of Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT02653547
Brief Title
Influence of Treatment Duration and Stimulation Frequency on rTMS in Chronic Tinnitus
Official Title
Influence of Treatment Duration and Stimulation Frequency on Repetitive Transcranial Magnetic Stimulation in Chronic Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 23, 2018 (Actual)
Study Completion Date
May 23, 2018 (Actual)

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
Patients receive two weeks of treatment (prefrontal high-frequency and bilateral low-frequency rTMS vs. prefrontal high-frequency and bilateral high-frequency rTMS). After two weeks of treatment they can decide if they want to quit the treatment or if they want to proceed with the treatment for another two weeks.
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 and non-auditory neural pathways. Low-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the temporoparietal areas has been investigated for the treatment of tinnitus based on the rationale to reduce increased activity of the auditory system. Furthermore, high-frequency stimulation of the left frontal cortex was added to this standard treatment based on rTMS studies in affective disorders and the association of tinnitus distress with depressivity. Thus, high-frequency stimulation of the left prefrontal cortex and low-frequency stimulation of bilateral temporoparietal cortex was introduced as new treatment scheme in chronic tinnitus (multisite standard). Additionally, there is also evidence that high-frequency stimulation of the temporoparietal cortex is effective in chronic tinnitus. Furthermore, standard treatment in chronic tinnitus is two weeks (ten treatment days) which is shorter than the standard in rTMS in affective disorders. Thus, the aim of the present trial is to investigate the influence of high-frequency stimulation of the temporoparietal cortex and of increasing the number of treatment days. Patients receive two weeks of treatment (prefrontal high-frequency and bilateral low-frequency rTMS vs. prefrontal high-frequency and bilateral high-frequency rTMS). After two weeks of treatment they can decide if they want to quit the treatment or if they want to proceed with the treatment for another two weeks.

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, rTMS, multisite stimulation, non-invasive brain stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard multisite four weeks
Arm Type
Experimental
Arm Description
Combined high-frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation; complete treatment of four weeks
Arm Title
high-frequency multisite four weeks
Arm Type
Experimental
Arm Description
Combined high-frequency dorsolateral prefrontal (unilateral) and high-frequency temporoparietal (bilateral) stimulation; complete treatment of four weeks
Arm Title
standard multisite two weeks
Arm Type
Experimental
Arm Description
Combined high-frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation; discontinuation after two weeks
Arm Title
high-frequency multisite two weeks
Arm Type
Experimental
Arm Description
Combined high-frequency dorsolateral prefrontal (unilateral) and high-frequency temporoparietal (bilateral) stimulation; discontinuation after two weeks
Intervention Type
Other
Intervention Name(s)
standard multisite four weeks
Intervention Description
Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients continue treatment after two weeks for further two weeks of treatment (20 treatment days).
Intervention Type
Other
Intervention Name(s)
high-frequency multisite four weeks
Intervention Description
Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients continue treatment after two weeks for further two weeks of treatment (20 treatment days).
Intervention Type
Other
Intervention Name(s)
standard multisite two weeks
Intervention Description
Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients discontinue treatment after two weeks (10 treatment days).
Intervention Type
Other
Intervention Name(s)
high-frequency multisite two weeks
Intervention Description
Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients discontinue treatment after two weeks (10 treatment days).
Primary Outcome Measure Information:
Title
change in tinnitus questionnaire
Description
change in tinnitus questionnaire
Time Frame
week12
Secondary Outcome Measure Information:
Title
change in tinnitus questionnaire
Description
change in tinnitus questionnaire
Time Frame
week2, week3, week4, week12
Title
change in tinnitus handicap inventory
Description
change in tinnitus handicap inventory
Time Frame
week2, week3, week4, week12
Title
change in tinnitus numeric rating scales
Description
change in tinnitus numeric rating scales
Time Frame
week2, week3, week4, week12
Title
change in major depression inventory
Description
change in major depression inventory
Time Frame
week2, week3, week4, week12
Title
change in clinical global impression
Description
change in clinical global impression
Time Frame
week2, week3, week4, week12
Title
change in quality of life
Description
change in quality of life
Time Frame
week2, week3, week4, week12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: written informed consent duration of tinnitus more than 6 months bothersome chronic tinnitus Exclusion Criteria: not stable internal, mental, and neurological diseases contraindication for rTMS (pacemaker, metal implants, pregnancy, epilepsy, status post severe craniocerebral injury ) uninvolvement in other treatment studies for tinnitus at the same time
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth
Organizational Affiliation
University of Regensburg, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regensburg- Dept of Psychiatry
City
Regensburg
ZIP/Postal Code
93053
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Influence of Treatment Duration and Stimulation Frequency on rTMS in Chronic Tinnitus

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