Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tinnitus |
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Safety and Effectiveness of Bilateral Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) in the Treatment of Chronic Tinnitus |
- Tinnitus severity (Tinnitus Questionnaire) [ Time Frame: after the end of treatment ]
- Visual Analog Scale (Tinnitus Loudness); Visual Analog Scale (Tinnitus Annoyance); Visual Analog Scale (Tinnitus Change); Becks Depression Inventory; Symptom Check List; Audiogram; Speech Audiometry [ Time Frame: after end of treatment ]
| Estimated Enrollment: | 48 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Bilateral theta burst stimulation to the secondary auditory cortex
|
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
Bilateral Theta Burst Stimulation
|
|
Experimental: 2
Bilateral theta burst stimulation to the tertiary auditory cortex
|
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
Bilateral Theta Burst Stimulation
|
|
Sham Comparator: 3
Bilateral theta burst stimulation to a non-cortical region
|
Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)
Bilateral Theta Burst Stimulation
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjective tinnitus > 6 mo , < 5 ys
Exclusion Criteria:
- Objective tinnitus
- Seizures
- Brain trauma
- Brain surgery
- Pacemaker
- intake of: benzodiazepines, antiepileptics, neuroleptics
- Suicidality
Contacts and Locations| Germany | |
| Department of General Psychiatry, University Hospital Tuebingen | |
| Tuebingen, Germany, D-72072 | |
| Principal Investigator: | Christian Plewnia, M.D. | University of Tuebingen, Department of General Psychiatry |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00518024 History of Changes |
| Other Study ID Numbers: | PL 525/1-1 |
| Study First Received: | August 15, 2007 |
| Last Updated: | June 28, 2010 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University Hospital Tuebingen:
|
tinnitus transcranial magnetic stimulation treatment cortex |
Additional relevant MeSH terms:
|
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013