Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus

Phase 2

Completed

• Conditions: Tinnitus
• Interventions: Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)

• Registration Number: NCT00518024
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

Tinnitus, i.e., the perception of sounds or noise in the absence of auditory stimuli, is a frequent and often severely disabling symptom of different disorders of the auditory system. There are currently no causal treatments. Using repetitive transcranial magnetic stimulation (rTMS), we have previously demonstrated that the temporoparietal cortex is critically involved in tinnitus perception and that tinnitus can be reduced by rTMS applied to these cortical regions. Therefore, it is reasonable to test rTMS as a potential new treatment strategy against tinnitus. At this stage, small pilot studies indicate some effect on tinnitus impairment but the reduction is predominantly reported to be transient, with high interindividual variability, and questionable clinical relevance. Moreover, the optimal stimulation area is unclear.

Here, we use theta burst stimulation (TBS), a new rTMS paradigm for the prolonged modulation of cortical activity. The aim of this study is to test safety and effectivity of 4 weeks of daily bilateral TBS to two cortical areas on chronic tinnitus compared to sham-stimulation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-15
• Study First Submitted QC: 2007-08-15
• Study First Posted: 2007-08-17
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-28
• Last Update Posted: 2010-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Subjective tinnitus > 6 mo , < 5 ys

Exclusion Criteria

• Objective tinnitus
• Seizures
• Brain trauma
• Brain surgery
• Pacemaker
• intake of: benzodiazepines, antiepileptics, neuroleptics
• Suicidality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Repetitive Transcranial Magnetic Stimulation (rTMS)	Bilateral theta burst stimulation to the secondary auditory cortex
2	Repetitive Transcranial Magnetic Stimulation (rTMS)	Bilateral theta burst stimulation to the tertiary auditory cortex
3	Repetitive Transcranial Magnetic Stimulation (rTMS)	Bilateral theta burst stimulation to a non-cortical region

Primary Outcome Measures

Name	Time	Method
Tinnitus severity (Tinnitus Questionnaire)	after the end of treatment

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (Tinnitus Loudness); Visual Analog Scale (Tinnitus Annoyance); Visual Analog Scale (Tinnitus Change); Becks Depression Inventory; Symptom Check List; Audiogram; Speech Audiometry	after end of treatment

Trial Locations

Locations (1)

Department of General Psychiatry, University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany