- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03957122
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
Intervention / Treatment
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
-
-
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Regensburg, Germany, 93053
- Department of Psychiatry and Psychotherapy, University of Regensburg
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-
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
|
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
|
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
|
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
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Tinnitus Questionnaire short version
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12 weeks
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THI
Time Frame: 12 weeks
|
Tinnitus Handicap inventory
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12 weeks
|
Tinnitus Severity
Time Frame: 12 weeks
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Tinnitus numeric Rating scales [0(best) - 10(worst)]
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12 weeks
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MDI
Time Frame: 12 weeks
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Major Depression Inventory
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12 weeks
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WHO-QOL BREF
Time Frame: 12 weeks
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Quality of life [4(worst) - 20(best)]
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12 weeks
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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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-820-101
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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