Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Tinnitus severity (Tinnitus Questionnaire) [after the end of treatment]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of General Psychiatry, University Hospital Tuebingen | Tuebingen | Germany | D-72072 |
Sponsors and Collaborators
- University Hospital Tuebingen
- German Research Foundation
- CenTrial GmbH
Investigators
- Principal Investigator: Christian Plewnia, M.D., University of Tuebingen, Department of General Psychiatry
Study Documents (Full-Text)
None provided.More Information
Publications
- De Ridder D, Verstraeten E, Van der Kelen K, De Mulder G, Sunaert S, Verlooy J, Van de Heyning P, Moller A. Transcranial magnetic stimulation for tinnitus: influence of tinnitus duration on stimulation parameter choice and maximal tinnitus suppression. Otol Neurotol. 2005 Jul;26(4):616-9.
- Eichhammer P, Langguth B, Marienhagen J, Kleinjung T, Hajak G. Neuronavigated repetitive transcranial magnetic stimulation in patients with tinnitus: a short case series. Biol Psychiatry. 2003 Oct 15;54(8):862-5.
- Fregni F, Marcondes R, Boggio PS, Marcolin MA, Rigonatti SP, Sanchez TG, Nitsche MA, Pascual-Leone A. Transient tinnitus suppression induced by repetitive transcranial magnetic stimulation and transcranial direct current stimulation. Eur J Neurol. 2006 Sep;13(9):996-1001.
- Kleinjung T, Eichhammer P, Langguth B, Jacob P, Marienhagen J, Hajak G, Wolf SR, Strutz J. Long-term effects of repetitive transcranial magnetic stimulation (rTMS) in patients with chronic tinnitus. Otolaryngol Head Neck Surg. 2005 Apr;132(4):566-9.
- Plewnia C, Bartels M, Gerloff C. Transient suppression of tinnitus by transcranial magnetic stimulation. Ann Neurol. 2003 Feb;53(2):263-6.
- Plewnia C, Reimold M, Najib A, Brehm B, Reischl G, Plontke SK, Gerloff C. Dose-dependent attenuation of auditory phantom perception (tinnitus) by PET-guided repetitive transcranial magnetic stimulation. Hum Brain Mapp. 2007 Mar;28(3):238-46.
- Plewnia C, Reimold M, Najib A, Reischl G, Plontke SK, Gerloff C. Moderate therapeutic efficacy of positron emission tomography-navigated repetitive transcranial magnetic stimulation for chronic tinnitus: a randomised, controlled pilot study. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):152-6. Epub 2006 Aug 4.
- Rossi S, De Capua A, Ulivelli M, Bartalini S, Falzarano V, Filippone G, Passero S. Effects of repetitive transcranial magnetic stimulation on chronic tinnitus: a randomised, crossover, double blind, placebo controlled study. J Neurol Neurosurg Psychiatry. 2007 Aug;78(8):857-63. Epub 2007 Feb 21.
- Smith JA, Mennemeier M, Bartel T, Chelette KC, Kimbrell T, Triggs W, Dornhoffer JL. Repetitive transcranial magnetic stimulation for tinnitus: a pilot study. Laryngoscope. 2007 Mar;117(3):529-34.
- PL 525/1-1