Influence of Treatment Duration and Stimulation Frequency on rTMS in Chronic Tinnitus

NCT ID: NCT02653547

Last Updated: 2018-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-05-23

Brief Summary

Patients receive two weeks of treatment (prefrontal high-frequency and bilateral low-frequency rTMS vs. prefrontal high-frequency and bilateral high-frequency rTMS). After two weeks of treatment they can decide if they want to quit the treatment or if they want to proceed with the treatment for another two weeks.

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. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory and non-auditory neural pathways. Low-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the temporoparietal areas has been investigated for the treatment of tinnitus based on the rationale to reduce increased activity of the auditory system. Furthermore, high-frequency stimulation of the left frontal cortex was added to this standard treatment based on rTMS studies in affective disorders and the association of tinnitus distress with depressivity. Thus, high-frequency stimulation of the left prefrontal cortex and low-frequency stimulation of bilateral temporoparietal cortex was introduced as new treatment scheme in chronic tinnitus (multisite standard).

Additionally, there is also evidence that high-frequency stimulation of the temporoparietal cortex is effective in chronic tinnitus. Furthermore, standard treatment in chronic tinnitus is two weeks (ten treatment days) which is shorter than the standard in rTMS in affective disorders. Thus, the aim of the present trial is to investigate the influence of high-frequency stimulation of the temporoparietal cortex and of increasing the number of treatment days.

Patients receive two weeks of treatment (prefrontal high-frequency and bilateral low-frequency rTMS vs. prefrontal high-frequency and bilateral high-frequency rTMS). After two weeks of treatment they can decide if they want to quit the treatment or if they want to proceed with the treatment for another two weeks.

Conditions

Chronic Tinnitus

Study Design

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

Study Groups

standard multisite four weeks

Combined high-frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation; complete treatment of four weeks

Group Type: EXPERIMENTAL

standard multisite four weeks

Intervention Type: OTHER

Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients continue treatment after two weeks for further two weeks of treatment (20 treatment days).

high-frequency multisite four weeks

Combined high-frequency dorsolateral prefrontal (unilateral) and high-frequency temporoparietal (bilateral) stimulation; complete treatment of four weeks

Group Type: EXPERIMENTAL

high-frequency multisite four weeks

Intervention Type: OTHER

Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients continue treatment after two weeks for further two weeks of treatment (20 treatment days).

standard multisite two weeks

Combined high-frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation; discontinuation after two weeks

Group Type: EXPERIMENTAL

standard multisite two weeks

Intervention Type: OTHER

Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients discontinue treatment after two weeks (10 treatment days).

high-frequency multisite two weeks

Combined high-frequency dorsolateral prefrontal (unilateral) and high-frequency temporoparietal (bilateral) stimulation; discontinuation after two weeks

Group Type: EXPERIMENTAL

high-frequency multisite two weeks

Intervention Type: OTHER

Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients discontinue treatment after two weeks (10 treatment days).

Interventions

standard multisite four weeks

Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients continue treatment after two weeks for further two weeks of treatment (20 treatment days).

Intervention Type: OTHER

high-frequency multisite four weeks

Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients continue treatment after two weeks for further two weeks of treatment (20 treatment days).

Intervention Type: OTHER

standard multisite two weeks

Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients discontinue treatment after two weeks (10 treatment days).

Intervention Type: OTHER

high-frequency multisite two weeks

Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients discontinue treatment after two weeks (10 treatment days).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• written informed consent
• duration of tinnitus more than 6 months
• bothersome chronic tinnitus

Exclusion Criteria

• not stable internal, mental, and neurological diseases
• contraindication for rTMS (pacemaker, metal implants, pregnancy, epilepsy, status post severe craniocerebral injury )
• uninvolvement in other treatment studies for tinnitus at the same time

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Regensburg

OTHER

Sponsor Role: lead

Responsible Party

Berthold Langguth, MD, Ph.D.

M.D., Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berthold Langguth

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg, Department of Psychiatry

Locations

University of Regensburg- Dept of Psychiatry

Regensburg, , Germany

Countries

Germany

Other Identifiers

dur-freq-rTMS-tin

Identifier Type: -

Identifier Source: org_study_id