An interventional study of repetitive transcranial magnetic stimulation in Tinnitus, sponsored by University of Regensburg. Terminated at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-19.
Sponsored by University of Regensburg · Not applicable, Interventional, and Treatment
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.
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.
412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 339 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →University of Regensburg is the lead sponsor of 67 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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).
Device: repetitive transcranial magnetic stimulation
Treatment with standard protocol: left-sided 1Hz in the group of patients who showed temporary reductions in tinnitus loudness in test sessions.
Device: repetitive transcranial magnetic stimulation
Treatment with standard protocol: left-sided 1Hz in the group of patients who did not show temporary reductions in tinnitus loudness in test sessions.
Device: repetitive transcranial magnetic stimulation
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
TFI
Tinnitus Functional Index
Time frame: 2 weeks
TFI
Tinnitus Functional Index
Time frame: 12 weeks
Mini-TQ
Tinnitus Questionnaire short version
Time frame: 12 weeks
THI
Tinnitus Handicap inventory
Time frame: 12 weeks
Tinnitus Severity
Tinnitus numeric Rating scales \[0(best) - 10(worst)\]
Time frame: 12 weeks
MDI
Major Depression Inventory
Time frame: 12 weeks
WHO-QOL BREF
Quality of life \[4(worst) - 20(best)\]
Time frame: 12 weeks
CGI
clinical global Impression Change \[1(best) - 7(worst)\]
Time frame: 12 weeks
Plan to share: No
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This study is terminated, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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University of Regensburg