Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation (indiTMS)

December 17, 2019 updated by: Berthold Langguth, MD, Ph.D., University of Regensburg
In the first visit a magnetic resonance imaging measurement will be done for the use of a neuronavigation System with the aim to control for stable coil position over the course of the trial. EEG positions CP5/CP6 will be used for positioning the coil. Two test sessions will examine the temporary reductions in tinnitus loudness after 1Hz, 10Hz, 20Hz and 0.1Hz rTMS as control condition over left and right temporo-parietal junction accompanied by electroencephalography. For the two-week treatment three arms will be evaluated: standard treatment (1Hz left-sided) in the groups with and without temporary reductions in test sessions and the best protocol as elicited in test sessions.

Study Overview

Status

Terminated

Conditions

Detailed Description

Efficacy of repetitive transcranial magnetic stimulation (rTMS) in chronic tinnitus is moderate. So far single sessions and daily treatment of rTMS were rarely combined. Thus it is not clear if temporary reductions in tinnitus loudness as elicited by short single rTMS sessions can be transferred to daily rTMS treatment. Thus, the aim of the study is to investigate the efficacy and reliability of single sessions of rTMS in chronic tinnitus with respect to temporary reductions in tinnitus loudness accompanied with resting state electroencephalography measurements to investigate the neurophysiological correlates of tinnitus reductions. Two test sessions within one week will be done on the left and right temporoparietal junction using 1Hz, 10Hz, 20Hz and 0.1Hz as active control condition. In the next step patients are divided into three arms with the aim to investigate the efficacy of individualized rTMS. The three arms are 1) patients with temporary tinnitus reductions in test sessions: treatment with the best, most reliable, controlled and most tolerable protocol, 2) patients with temporary tinnitus reductions in test sessions: treatment with 1Hz left-sided rTMS, 3) patients with no temporary tinnitus reductions in test sessions: treatment with 1Hz left-sided rTMS. Treatment will be done for 10 days (Monday - Friday) using 2000 pulses with 110% resting motor threshold. Coil position will be tracked with neuronavigation to ensure stable coil Position over the course of the trial.

Study Type

Interventional

Enrollment (Actual)

22

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

      • Regensburg, Germany, 93053
        • Department of Psychiatry and Psychotherapy, University of Regensburg

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • chronic tinnitus (> 6 months)
  • at least moderate tinnitus distress
  • no or consistent medication
  • no or consistent Treatments
  • residence in Germany and German speaking

Exclusion Criteria:

  • objective tinnitus
  • serious and not stable illness (e.g. acute psychosis, severe depression or substance dependence, epilepsy, brain tumor)
  • meeting the contraindications for transcranial magnetic stimulation or magnetic resonance imaging (electric devices or metal implants in the body, e.g. cardiac pace maker, insulin pump)
  • neurological disorders (e.g. cerebrovascular events, neurodegenerative disorder, epilepsy, brain malformation, severe head trauma)
  • addictive disorder with consumption in the last two years
  • regular intake of benzodiazepines
  • participation in another study parallel to the trial
  • pregnancy or breastfeeding period
  • psychiatric confinement

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: individualized rTMS
Treatment with the best (highest reduction in tinnitus loudness, most reliable, superior to control condition, most tolerable) protocol as obtained in the test sessions (left vs. right temporoparietal junction, 1Hz, 10Hz, 20Hz, 0.1Hz as active control condition).

Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation

  • 2000 pulses
  • intensity of 110% resting motor threshold
  • 10 sessions (daily from Monday to Friday)
  • positioning of coil according to EEG position CP5/CP6
Active Comparator: standard rTMS in responders
Treatment with standard protocol: left-sided 1Hz in the group of patients who showed temporary reductions in tinnitus loudness in test sessions.

Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation

  • 2000 pulses
  • intensity of 110% resting motor threshold
  • 10 sessions (daily from Monday to Friday)
  • positioning of coil according to EEG position CP5/CP6
Active Comparator: standard rTMS in non-responders
Treatment with standard protocol: left-sided 1Hz in the group of patients who did not show temporary reductions in tinnitus loudness in test sessions.

Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation

  • 2000 pulses
  • intensity of 110% resting motor threshold
  • 10 sessions (daily from Monday to Friday)
  • positioning of coil according to EEG position CP5/CP6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TFI
Time Frame: 2 weeks
Tinnitus Functional Index
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TFI
Time Frame: 12 weeks
Tinnitus Functional Index
12 weeks
Mini-TQ
Time Frame: 12 weeks
Tinnitus Questionnaire short version
12 weeks
THI
Time Frame: 12 weeks
Tinnitus Handicap inventory
12 weeks
Tinnitus Severity
Time Frame: 12 weeks
Tinnitus numeric Rating scales [0(best) - 10(worst)]
12 weeks
MDI
Time Frame: 12 weeks
Major Depression Inventory
12 weeks
WHO-QOL BREF
Time Frame: 12 weeks
Quality of life [4(worst) - 20(best)]
12 weeks
CGI
Time Frame: 12 weeks
clinical global Impression Change [1(best) - 7(worst)]
12 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Berthold Langguth, University of Regensburg

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 (Actual)

May 1, 2019

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

May 16, 2019

First Posted (Actual)

May 21, 2019

Study Record Updates

Last Update Posted (Actual)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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