Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Wuerzburg | OTHER |
| University Hospital Tuebingen | OTHER |
| University Hospital Muenster | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Neuronavigated continuous theta burst stimulation of the left Heschl's gyrus is used to modulate auditory cortex activity and plasticity contributing to the perception and distress of chronic tinnitus.
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. One significant modulator of tinnitus is stress. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. Repetitive transcranial magnetic stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size. Pilot data were positive for low-frequency rTMS applied to the temporal and temporoparietal areas. Continuous theta burst stimulation (cTBS) is a new protocol of rTMS with a possible superior effect in contrast to low-frequency rTMS. Also anatomical neuronavigation might increase the efficacy of rTMS due to exact targeting of the primary auditory cortex. Thus, the aim of this study is the evaluation of the clinical efficacy of neuronavigated left-sided cTBS in chronic tinnitus in a randomised sham-controlled two-arm design.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left temporal verum cTBS | Experimental | Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session) Intervention: Left temporal verum cTBS |
|
| Left temporal placebo cTBS | Experimental | Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session); coil tilted by 45° over both wings Intervention: Left temporal placebo cTBS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left temporal verum cTBS | Device | Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session) Arms: Left temporal verum cTBS |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tinnitus questionnaire total score (contrast baseline (-day 3) versus end of treatment (day 10)) | -day 3; day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of tinnitus questionaire total score (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8)) | -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8 | |
| Change of tinnitus handicap inventory total score (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8)) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Berthold Langguth | University of Regensburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Muenster | Münster | Germany | ||||
| University of Regensburg - Dept of Psychiatry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Left temporal placebo cTBS | Device | Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session); coil tilted by 45° over both wings Arms: Left temporal placebo cTBS |
|
|
| -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8 |
| Change of tinnitus numeric rating scales (all baseline (-week 2, - week1, - day 3) vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8)) | -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8 |
| Change of depressive symptoms as measured by the Beck Depression Inventory II (BDI) (baseline visit -week 2 vs. all follow-up visits (day 6, day 10, week 1, week 3, week 8)) | -week 2; day 6; day 10; week 1; week 3; week 8 |
| Regensburg |
| Germany |
| University of Tuebingen | Tübingen | Germany |
| University of Wuerzburg | Würzburg | Germany |