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

NCT ID: NCT00518024

Last Updated: 2010-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Bilateral theta burst stimulation to the secondary auditory cortex

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: PROCEDURE

Bilateral Theta Burst Stimulation

2

Bilateral theta burst stimulation to the tertiary auditory cortex

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: PROCEDURE

Bilateral Theta Burst Stimulation

3

Bilateral theta burst stimulation to a non-cortical region

Group Type: SHAM_COMPARATOR

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: PROCEDURE

Bilateral Theta Burst Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

Bilateral Theta Burst Stimulation

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

CenTrial GmbH

INDUSTRY

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Principal Investigators

Christian Plewnia, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Tuebingen, Department of General Psychiatry

Locations

Department of General Psychiatry, University Hospital Tuebingen

Tübingen, , Germany

Countries

Germany

References

Arfeller C, Vonthein R, Plontke SK, Plewnia C. Efficacy and safety of bilateral continuous theta burst stimulation (cTBS) for the treatment of chronic tinnitus: design of a three-armed randomized controlled trial. Trials. 2009 Aug 21;10:74. doi: 10.1186/1745-6215-10-74.

Reference Type: DERIVED

PMID: 19698089 (View on PubMed)

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. doi: 10.1097/01.mao.0000178146.91139.3c.

Reference Type: BACKGROUND

PMID: 16015156 (View on PubMed)

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. doi: 10.1016/j.otohns.2004.09.134.

Reference Type: BACKGROUND

PMID: 15806046 (View on PubMed)

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. doi: 10.1016/s0006-3223(02)01896-6.

Reference Type: BACKGROUND

PMID: 14550687 (View on PubMed)

Plewnia C, Bartels M, Gerloff C. Transient suppression of tinnitus by transcranial magnetic stimulation. Ann Neurol. 2003 Feb;53(2):263-6. doi: 10.1002/ana.10468.

Reference Type: BACKGROUND

PMID: 12557296 (View on PubMed)

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. doi: 10.1136/jnnp.2006.095612. Epub 2006 Aug 4.

Reference Type: BACKGROUND

PMID: 16891384 (View on PubMed)

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. doi: 10.1002/hbm.20270.

Reference Type: BACKGROUND

PMID: 16773635 (View on PubMed)

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. doi: 10.1097/MLG.0b013e31802f4154.

Reference Type: BACKGROUND

PMID: 17334317 (View on PubMed)

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. doi: 10.1136/jnnp.2006.105007. Epub 2007 Feb 21.

Reference Type: BACKGROUND

PMID: 17314192 (View on PubMed)

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. doi: 10.1111/j.1468-1331.2006.01414.x.

Reference Type: BACKGROUND

PMID: 16930367 (View on PubMed)

Other Identifiers

PL 525/1-1

Identifier Type: -

Identifier Source: org_study_id