Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation (indiTMS)
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ClinicalTrials.gov Identifier: NCT03957122 |
Recruitment Status :
Terminated
(The number of responders in the test sessions was too low.)
First Posted : May 21, 2019
Last Update Posted : December 19, 2019
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Condition or disease | Intervention/treatment | Phase |
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Tinnitus | Device: repetitive transcranial magnetic stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation |
Actual Study Start Date : | May 1, 2019 |
Actual Primary Completion Date : | November 30, 2019 |
Actual Study Completion Date : | November 30, 2019 |
Arm | Intervention/treatment |
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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).
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Device: repetitive transcranial magnetic stimulation
Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation
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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.
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Device: repetitive transcranial magnetic stimulation
Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation
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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.
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Device: repetitive transcranial magnetic stimulation
Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation
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- TFI [ Time Frame: 2 weeks ]Tinnitus Functional Index
- TFI [ Time Frame: 12 weeks ]Tinnitus Functional Index
- Mini-TQ [ Time Frame: 12 weeks ]Tinnitus Questionnaire short version
- THI [ Time Frame: 12 weeks ]Tinnitus Handicap inventory
- Tinnitus Severity [ Time Frame: 12 weeks ]Tinnitus numeric Rating scales [0(best) - 10(worst)]
- MDI [ Time Frame: 12 weeks ]Major Depression Inventory
- WHO-QOL BREF [ Time Frame: 12 weeks ]Quality of life [4(worst) - 20(best)]
- CGI [ Time Frame: 12 weeks ]clinical global Impression Change [1(best) - 7(worst)]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957122
Germany | |
Department of Psychiatry and Psychotherapy, University of Regensburg | |
Regensburg, Germany, 93053 |
Principal Investigator: | Berthold Langguth | University of Regensburg |
Responsible Party: | Berthold Langguth, MD, Ph.D., Head of Center II and out-patient clinic of the Department of Psychiatry and Psychotherapy, University of Regensburg |
ClinicalTrials.gov Identifier: | NCT03957122 |
Other Study ID Numbers: |
17-820-101 |
First Posted: | May 21, 2019 Key Record Dates |
Last Update Posted: | December 19, 2019 |
Last Verified: | December 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
tinnitus transcranial magnetic stimulation |
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases |