Effectiveness of Neuronavigated Continuous Theta Burst Stimulation of the Left Heschl's Gyrus in Chronic Tinnitus

NCT ID: NCT02199106

Last Updated: 2014-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-05-31

Brief 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.

Detailed 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.

Conditions

Chronic Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Intervention: Left temporal verum cTBS

Group Type: EXPERIMENTAL

Left temporal verum cTBS

Intervention Type: 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

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

Intervention: Left temporal placebo cTBS

Group Type: EXPERIMENTAL

Left temporal placebo cTBS

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Other Intervention Names

MC-B70, MagPro,MagOption, Medtronic, Germany; MC-B70, MagPro,MagOption, Medtronic, Germany

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wuerzburg

OTHER

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: collaborator

University of Regensburg

OTHER

Sponsor Role: lead

Responsible Party

Berthold Langguth, MD, Ph.D.

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berthold Langguth

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg

Locations

University of Muenster

Münster, , Germany

University of Regensburg - Dept of Psychiatry

Regensburg, , Germany

University of Tuebingen

Tübingen, , Germany

University of Wuerzburg

Würzburg, , Germany

Countries

Germany

Other Identifiers

Ti-cTBS

Identifier Type: -

Identifier Source: org_study_id