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

NCT00518024 | Completed Phase 2 DMC

• 1 other identifier: PL 525/1-1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

tinnitus; transcranial magnetic stimulation; treatment; cortex

Outcome Measures

Primary Outcomes (1)

• Tinnitus severity (Tinnitus Questionnaire)

  after the end of treatment

Secondary Outcomes (1)

• 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

Study Arms (3)

1

EXPERIMENTAL

Bilateral theta burst stimulation to the secondary auditory cortex

Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)

2

EXPERIMENTAL

Bilateral theta burst stimulation to the tertiary auditory cortex

Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)

3

SHAM COMPARATOR

Bilateral theta burst stimulation to a non-cortical region

Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) PROCEDURE

Bilateral Theta Burst Stimulation

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjective tinnitus \> 6 mo , \< 5 ys

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• German Research Foundation: collaborator
• CenTrial GmbH: collaborator

Study Sites (1)

Department of General Psychiatry, University Hospital Tuebingen

Tübingen, D-72072, Germany

Location

Related Publications (10)

• 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.

  PMID: 16891384 BACKGROUND

• 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.

  PMID: 16773635 BACKGROUND

• 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.

  PMID: 17334317 BACKGROUND

• 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.

  PMID: 17314192 BACKGROUND

• 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.

  PMID: 16930367 BACKGROUND

• 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.

  PMID: 16015156 BACKGROUND

• 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.

  PMID: 15806046 BACKGROUND

• 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.

  PMID: 14550687 BACKGROUND

• 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.

  PMID: 12557296 BACKGROUND

• 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.

  PMID: 19698089 DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Christian Plewnia, M.D.

  University of Tuebingen, Department of General Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 17, 2007
• Last Updated: June 29, 2010

Record last verified: 2010-06

Locations

DE (1)