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

Not Applicable

Completed

• Conditions: Chronic Tinnitus
• Interventions: Other: high-frequency multisite two weeks; Other: high-frequency multisite four weeks; Other: standard multisite two weeks; Other: standard multisite four weeks

• Registration Number: NCT02653547
• Lead Sponsor: University of Regensburg

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-12
• Primary Completion: 2018-05-23
• Study Completion: 2018-05-23
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-14
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high-frequency multisite two weeks	high-frequency multisite two weeks	Combined high-frequency dorsolateral prefrontal (unilateral) and high-frequency temporoparietal (bilateral) stimulation; discontinuation after two weeks
high-frequency multisite four weeks	high-frequency multisite four weeks	Combined high-frequency dorsolateral prefrontal (unilateral) and high-frequency temporoparietal (bilateral) stimulation; complete treatment of four weeks
standard multisite two weeks	standard multisite two weeks	Combined high-frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation; discontinuation after two weeks
standard multisite four weeks	standard multisite four weeks	Combined high-frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation; complete treatment of four weeks

Primary Outcome Measures

Name	Time	Method
change in tinnitus questionnaire	week12	change in tinnitus questionnaire

Secondary Outcome Measures

Name	Time	Method
change in tinnitus handicap inventory	week2, week3, week4, week12	change in tinnitus handicap inventory
change in tinnitus numeric rating scales	week2, week3, week4, week12	change in tinnitus numeric rating scales
change in major depression inventory	week2, week3, week4, week12	change in major depression inventory
change in clinical global impression	week2, week3, week4, week12	change in clinical global impression
change in quality of life	week2, week3, week4, week12	change in quality of life
change in tinnitus questionnaire	week2, week3, week4, week12	change in tinnitus questionnaire

Trial Locations

Locations (1)

University of Regensburg- Dept of Psychiatry; 🇩🇪 Regensburg, Germany