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

June 14, 2018 updated by: Berthold Langguth, MD, Ph.D., University of Regensburg

Influence of Treatment Duration and Stimulation Frequency on Repetitive Transcranial Magnetic Stimulation in Chronic Tinnitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Regensburg, Germany, 93053
        • University of Regensburg- Dept of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: standard multisite four weeks
Combined high-frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation; complete treatment of four weeks
Other: standard multisite four weeks
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).
Experimental: high-frequency multisite four weeks
Combined high-frequency dorsolateral prefrontal (unilateral) and high-frequency temporoparietal (bilateral) stimulation; complete treatment of four weeks
Other: high-frequency multisite four weeks
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).
Experimental: standard multisite two weeks
Combined high-frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation; discontinuation after two weeks
Other: standard multisite two weeks
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).
Experimental: high-frequency multisite two weeks
Combined high-frequency dorsolateral prefrontal (unilateral) and high-frequency temporoparietal (bilateral) stimulation; discontinuation after two weeks
Other: high-frequency multisite two weeks
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in tinnitus questionnaire
Time Frame: week12
change in tinnitus questionnaire
week12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in tinnitus questionnaire
Time Frame: week2, week3, week4, week12
change in tinnitus questionnaire
week2, week3, week4, week12
change in tinnitus handicap inventory
Time Frame: week2, week3, week4, week12
change in tinnitus handicap inventory
week2, week3, week4, week12
change in tinnitus numeric rating scales
Time Frame: week2, week3, week4, week12
change in tinnitus numeric rating scales
week2, week3, week4, week12
change in major depression inventory
Time Frame: week2, week3, week4, week12
change in major depression inventory
week2, week3, week4, week12
change in clinical global impression
Time Frame: week2, week3, week4, week12
change in clinical global impression
week2, week3, week4, week12
change in quality of life
Time Frame: week2, week3, week4, week12
change in quality of life
week2, week3, week4, week12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Regensburg

Investigators

  • Principal Investigator: Berthold Langguth, University of Regensburg, Department of Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

May 23, 2018

Study Completion (Actual)

May 23, 2018

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 8, 2016

First Posted (Estimate)

January 12, 2016

Study Record Updates

Last Update Posted (Actual)

June 18, 2018

Last Update Submitted That Met QC Criteria

June 14, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dur-freq-rTMS-tin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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