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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02199106
Other study ID # Ti-cTBS
Secondary ID
Status Completed
Phase N/A
First received July 22, 2014
Last updated July 23, 2014
Start date January 2009
Est. completion date May 2011

Study information

Verified date July 2014
Source University of Regensburg
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date May 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Diagnosis of bothersome, subjective chronic tinnitus

- Duration of tinnitus more than 6 months

Exclusion Criteria:

- Objective tinnitus

- Treatable cause of the tinnitus

- Involvement in other treatments for tinnitus at the same time

- Clinically relevant psychiatric comorbidity

- Clinically relevant unstable internal or neurological comorbidity

- History of or evidence of significant brain malformation or neoplasm, head injury

- Cerebral vascular events

- Neurodegenerative disorder affecting the brain or prior brain surgery

- Metal objects in and around body that can not be removed

- Pregnancy

- Alcohol or drug abuse

- acute or chronic inflammation of the middle ear, Meniere diseases, sudden idiopathic hearing loss, fluctuating hearing

- history of seizures

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Left temporal verum cTBS
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
Left temporal placebo cTBS
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

Locations

Country Name City State
Germany University of Muenster Muenster
Germany University of Regensburg - Dept of Psychiatry Regensburg
Germany University of Tuebingen Tuebingen
Germany University of Wuerzburg Wuerzburg

Sponsors (4)

Lead Sponsor Collaborator
University of Regensburg University Hospital Muenster, University Hospital Tuebingen, University of Wuerzburg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in tinnitus questionnaire total score (contrast baseline (-day 3) versus end of treatment (day 10)) -day 3; day 10 No
Secondary 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 No
Secondary 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)) -week 2; - week1; - day 3; day 6; day 10; week 1; week 3; week 8 No
Secondary 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 No
Secondary 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 No
See also
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Completed NCT01663324 - rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network N/A
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Recruiting NCT03657615 - Hearing Aid Impact on Chronic Tinnitus Patients Evaluated by Resting State PET. N/A
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