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

Tinnitus Clinical Trial

Official title:

Safety and Effectiveness of Bilateral Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) in the Treatment of Chronic Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518024
• Other study ID #: PL 525/1-1
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2007
• Last updated: June 28, 2010

Study information

• Verified date: June 2010
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Procedure:
• Repetitive Transcranial Magnetic Stimulation (rTMS)
Bilateral Theta Burst Stimulation

Locations

Country	Name	City	State
Germany	Department of General Psychiatry, University Hospital Tuebingen	Tuebingen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Tuebingen	CenTrial GmbH, German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Plewnia C, Bartels M, Gerloff C. Transient suppression of tinnitus by transcranial magnetic stimulation. Ann Neurol. 2003 Feb;53(2):263-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus severity (Tinnitus Questionnaire)		after the end of treatment
Secondary	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