Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
Primary Purpose
Tinnitus
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, transcranial magnetic stimulation, treatment, cortex
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
Sites / Locations
- Department of General Psychiatry, University Hospital Tuebingen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
1
2
3
Arm Description
Bilateral theta burst stimulation to the secondary auditory cortex
Bilateral theta burst stimulation to the tertiary auditory cortex
Bilateral theta burst stimulation to a non-cortical region
Outcomes
Primary Outcome Measures
Tinnitus severity (Tinnitus Questionnaire)
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
Full Information
NCT ID
NCT00518024
First Posted
August 15, 2007
Last Updated
June 28, 2010
Sponsor
University Hospital Tuebingen
Collaborators
German Research Foundation, CenTrial GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00518024
Brief Title
Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
Official Title
Safety and Effectiveness of Bilateral Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) in the Treatment of Chronic Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Tuebingen
Collaborators
German Research Foundation, CenTrial GmbH
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus, transcranial magnetic stimulation, treatment, cortex
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Bilateral theta burst stimulation to the secondary auditory cortex
Arm Title
2
Arm Type
Experimental
Arm Description
Bilateral theta burst stimulation to the tertiary auditory cortex
Arm Title
3
Arm Type
Sham Comparator
Arm Description
Bilateral theta burst stimulation to a non-cortical region
Intervention Type
Procedure
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
Bilateral Theta Burst Stimulation
Primary Outcome Measure Information:
Title
Tinnitus severity (Tinnitus Questionnaire)
Time Frame
after the end of treatment
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Plewnia, M.D.
Organizational Affiliation
University of Tuebingen, Department of General Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General Psychiatry, University Hospital Tuebingen
City
Tuebingen
ZIP/Postal Code
D-72072
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
16891384
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. doi: 10.1136/jnnp.2006.095612. Epub 2006 Aug 4.
Results Reference
background
PubMed Identifier
16773635
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. doi: 10.1002/hbm.20270.
Results Reference
background
PubMed Identifier
17334317
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. doi: 10.1097/MLG.0b013e31802f4154.
Results Reference
background
PubMed Identifier
17314192
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. doi: 10.1136/jnnp.2006.105007. Epub 2007 Feb 21.
Results Reference
background
PubMed Identifier
16930367
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. doi: 10.1111/j.1468-1331.2006.01414.x.
Results Reference
background
PubMed Identifier
16015156
Citation
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.
Results Reference
background
PubMed Identifier
15806046
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. doi: 10.1016/j.otohns.2004.09.134.
Results Reference
background
PubMed Identifier
14550687
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. doi: 10.1016/s0006-3223(02)01896-6.
Results Reference
background
PubMed Identifier
12557296
Citation
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.
Results Reference
background
PubMed Identifier
19698089
Citation
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.
Results Reference
derived
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Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
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