Repetitive Transcranial Magnetic Stimulation for Chronic Subjective Tinnitus
NCT ID: NCT03425045
Last Updated: 2018-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2015-03-01
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Repetitive Transcranial Magnetic Stimulation
Patients in this study arm will undergo the rTMS stimulation as described above.
Repetitive Transcranial Magnetic Stimulation
Patients randomised in Arm 1 will receive stimulation of the dorsolateral prefrontal cortex (frequency 25 Hz; 300 pulses; 80% resting motor threshold=RMT) and primary auditory cortex on both sides (1 Hz; 1000 pulses; 110% RMT) will be stimulated in patients in rTMS stimulation group for 5 consecutive days. No medication therapy will be provided for patients in this arm.
Sham stimulation
Patients in this study arm will undergo the sham stimulation as described above.
Sham stimulation
Sham stimulation will be performed in patients randomised in Arm 2 of the study for 5 consecutive days. No medication therapy will be provided for patients in this arm.
Ginkgo Biloba Extract
Patients in this study arm will receive medication therapy as described above, without any rTMS or sham procedure.
Ginkgo Biloba Extract
Patients randomised in Arm 3 of the study will receive medication therapy with Ginkgo biloba extract EGb 761 once a day for 6 months.
Interventions
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Repetitive Transcranial Magnetic Stimulation
Patients randomised in Arm 1 will receive stimulation of the dorsolateral prefrontal cortex (frequency 25 Hz; 300 pulses; 80% resting motor threshold=RMT) and primary auditory cortex on both sides (1 Hz; 1000 pulses; 110% RMT) will be stimulated in patients in rTMS stimulation group for 5 consecutive days. No medication therapy will be provided for patients in this arm.
Sham stimulation
Sham stimulation will be performed in patients randomised in Arm 2 of the study for 5 consecutive days. No medication therapy will be provided for patients in this arm.
Ginkgo Biloba Extract
Patients randomised in Arm 3 of the study will receive medication therapy with Ginkgo biloba extract EGb 761 once a day for 6 months.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* epilepsy
* organic brain lesion
* Meniere's disease or fluctuating hearing loss
* cochlear or bone-anchored hearing device implantation
* history of suicide
* pregnancy
* therapy with anticonvulsants
* antipsychotic medication
* heart pacemaker implantation
* rTMS performed in the past
* not signing of the informed consent
18 Years
99 Years
ALL
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Michal Bar, Ass.Prof.,MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
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University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Countries
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References
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Folmer RL, Carroll JR, Rahim A, Shi Y, Hal Martin W. Effects of repetitive transcranial magnetic stimulation (rTMS) on chronic tinnitus. Acta Otolaryngol Suppl. 2006 Dec;(556):96-101. doi: 10.1080/03655230600895465.
Oberman L, Edwards D, Eldaief M, Pascual-Leone A. Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. J Clin Neurophysiol. 2011 Feb;28(1):67-74. doi: 10.1097/WNP.0b013e318205135f.
Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.
Kim BG, Kim DY, Kim SK, Kim JM, Baek SH, Moon IS. Comparison of the outcomes of repetitive transcranial magnetic stimulation to the ipsilateral and contralateral auditory cortex in unilateral tinnitus. Electromagn Biol Med. 2014 Sep;33(3):211-5. doi: 10.3109/15368378.2013.801353. Epub 2013 Jun 19.
Kleinjung T, Eichhammer P, Landgrebe M, Sand P, Hajak G, Steffens T, Strutz J, Langguth B. Combined temporal and prefrontal transcranial magnetic stimulation for tinnitus treatment: a pilot study. Otolaryngol Head Neck Surg. 2008 Apr;138(4):497-501. doi: 10.1016/j.otohns.2007.12.022.
Kreuzer PM, Landgrebe M, Schecklmann M, Poeppl TB, Vielsmeier V, Hajak G, Kleinjung T, Langguth B. Can Temporal Repetitive Transcranial Magnetic Stimulation be Enhanced by Targeting Affective Components of Tinnitus with Frontal rTMS? A Randomized Controlled Pilot Trial. Front Syst Neurosci. 2011 Nov 4;5:88. doi: 10.3389/fnsys.2011.00088. eCollection 2011.
De Ridder D, Song JJ, Vanneste S. Frontal cortex TMS for tinnitus. Brain Stimul. 2013 May;6(3):355-62. doi: 10.1016/j.brs.2012.07.002. Epub 2012 Jul 24.
Lehner A, Schecklmann M, Kreuzer PM, Poeppl TB, Rupprecht R, Langguth B. Comparing single-site with multisite rTMS for the treatment of chronic tinnitus - clinical effects and neuroscientific insights: study protocol for a randomized controlled trial. Trials. 2013 Aug 23;14:269. doi: 10.1186/1745-6215-14-269.
Lehner A, Schecklmann M, Poeppl TB, Kreuzer PM, Vielsmeier V, Rupprecht R, Landgrebe M, Langguth B. Multisite rTMS for the treatment of chronic tinnitus: stimulation of the cortical tinnitus network--a pilot study. Brain Topogr. 2013 Jul;26(3):501-10. doi: 10.1007/s10548-012-0268-4. Epub 2012 Dec 11.
Langguth B, Landgrebe M, Frank E, Schecklmann M, Sand PG, Vielsmeier V, Hajak G, Kleinjung T. Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus: Pooled analysis of two randomized controlled studies. World J Biol Psychiatry. 2014 May;15(4):276-85. doi: 10.3109/15622975.2012.708438. Epub 2012 Aug 22.
Hoekstra CE, Versnel H, Neggers SF, Niesten ME, van Zanten GA. Bilateral low-frequency repetitive transcranial magnetic stimulation of the auditory cortex in tinnitus patients is not effective: a randomised controlled trial. Audiol Neurootol. 2013;18(6):362-73. doi: 10.1159/000354977. Epub 2013 Oct 19.
Engelhardt J, Dauman R, Arne P, Allard M, Dauman N, Branchard O, Perez P, Germain C, Caire F, Bonnard D, Cuny E. Effect of chronic cortical stimulation on chronic severe tinnitus: a prospective randomized double-blind cross-over trial and long-term follow up. Brain Stimul. 2014 Sep-Oct;7(5):694-700. doi: 10.1016/j.brs.2014.05.008. Epub 2014 Jun 4.
Plewnia C, Vonthein R, Wasserka B, Arfeller C, Naumann A, Schraven SP, Plontke SK. Treatment of chronic tinnitus with theta burst stimulation: a randomized controlled trial. Neurology. 2012 May 22;78(21):1628-34. doi: 10.1212/WNL.0b013e3182574ef9. Epub 2012 Apr 25.
Roland LT, Peelle JE, Kallogjeri D, Nicklaus J, Piccirillo JF. The effect of noninvasive brain stimulation on neural connectivity in Tinnitus: A randomized trial. Laryngoscope. 2016 May;126(5):1201-6. doi: 10.1002/lary.25650. Epub 2015 Sep 30.
Kleinjung T, Steffens T, Sand P, Murthum T, Hajak G, Strutz J, Langguth B, Eichhammer P. Which tinnitus patients benefit from transcranial magnetic stimulation? Otolaryngol Head Neck Surg. 2007 Oct;137(4):589-95. doi: 10.1016/j.otohns.2006.12.007.
Khedr EM, Rothwell JC, Ahmed MA, El-Atar A. Effect of daily repetitive transcranial magnetic stimulation for treatment of tinnitus: comparison of different stimulus frequencies. J Neurol Neurosurg Psychiatry. 2008 Feb;79(2):212-5. doi: 10.1136/jnnp.2007.127712.
Marcondes RA, Sanchez TG, Kii MA, Ono CR, Buchpiguel CA, Langguth B, Marcolin MA. Repetitive transcranial magnetic stimulation improve tinnitus in normal hearing patients: a double-blind controlled, clinical and neuroimaging outcome study. Eur J Neurol. 2010 Jan;17(1):38-44. doi: 10.1111/j.1468-1331.2009.02730.x. Epub 2009 Jul 9.
Frank G, Kleinjung T, Landgrebe M, Vielsmeier V, Steffenhagen C, Burger J, Frank E, Vollberg G, Hajak G, Langguth B. Left temporal low-frequency rTMS for the treatment of tinnitus: clinical predictors of treatment outcome--a retrospective study. Eur J Neurol. 2010 Jul;17(7):951-6. doi: 10.1111/j.1468-1331.2010.02956.x. Epub 2010 Feb 10.
Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8. doi: 10.1001/archotol.1996.01890140029007.
Related Links
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The American Academy of Audiology is the world's largest professional organization of, by, and for audiologists.
Other Identifiers
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MH CZ-DRO (FNOs/2015)
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FNO-ENT-tinnitus
Identifier Type: -
Identifier Source: org_study_id
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