Neurofeedback for tinnitus: study protocol for a randomised controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both sound perception and psychological distress in a cohort of chronic tinnitus sufferers.
Adolescent
Adult
Aged
Aged, 80 and over
Alpha Rhythm
Auditory Perception
Chronic Disease
/ therapy
Cohort Studies
Delta Rhythm
Female
Germany
Humans
Male
Middle Aged
Neurofeedback
/ methods
Psychological Distress
Randomized Controlled Trials as Topic
Stress, Psychological
/ therapy
Tinnitus
/ therapy
Treatment Outcome
Young Adult
Neurofeedback, Chronic tinnitus, Severe tinnitus, Tinnitus patient, Electroencephalography, Tinnitus treatment
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
05 May 2020
05 May 2020
Historique:
received:
16
08
2019
accepted:
02
04
2020
entrez:
7
5
2020
pubmed:
7
5
2020
medline:
30
1
2021
Statut:
epublish
Résumé
Tinnitus is a particularly common condition and can have debilitating psychological consequences for certain people. Although several interventions have been helpful in teaching individuals to better cope with tinnitus, no cure exists at present. Neurofeedback is an emerging treatment modality in tinnitus. Previous studies, utilising an alpha/delta training protocol, have shown promise. However, they were characterised by small sample sizes and a lack of neurofeedback control conditions. Therefore, the aim of this study is to investigate whether an alpha/delta neurofeedback training protocol, compared to beta/theta neurofeedback or a diary control group, is effective in reducing not only the tinnitus sound perception but also the psychological symptoms associated with the condition. The study is designed as a three-armed randomised controlled trial. Participants are randomly assigned to a) an established neurofeedback protocol for tinnitus (alpha/delta training), b) an active control group (beta/theta training) or c) a diary control group. In the 4-week intervention period, participants in both neurofeedback groups undergo 10 sessions, whereas participants in the diary control group complete a bi-weekly diary. The primary outcomes are between group differences in tinnitus sound perception change, as measured with the Tinnitus Magnitude Index (TMI), and changes in tinnitus distress, measured with the Tinnitus Handicap Inventory (THI), 4 weeks after the start of the intervention. Secondary outcome measures include changes in tinnitus distress, sleep quality, depressive symptoms and whether neurofeedback leads to specific power changes in the trained frequency bands. This is the first randomised controlled trial examining the efficacy of an alpha/delta neurofeedback training protocol in reducing tinnitus sound perception and the distress associated with the condition. Compared to former studies, the present study is designed to assess both the specificity of an alpha/delta neurofeedback training protocol by including an active comparator and beta/theta neurofeedback training, in addition to controlling for placebo effects by the inclusion of a diary control group. This study aims to contribute to an understanding of the influences of both specific and non-specific effects in neurofeedback treatment for tinnitus. ClinicalTrials.gov: NCT03550430. Registered on 27 May 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Tinnitus is a particularly common condition and can have debilitating psychological consequences for certain people. Although several interventions have been helpful in teaching individuals to better cope with tinnitus, no cure exists at present. Neurofeedback is an emerging treatment modality in tinnitus. Previous studies, utilising an alpha/delta training protocol, have shown promise. However, they were characterised by small sample sizes and a lack of neurofeedback control conditions. Therefore, the aim of this study is to investigate whether an alpha/delta neurofeedback training protocol, compared to beta/theta neurofeedback or a diary control group, is effective in reducing not only the tinnitus sound perception but also the psychological symptoms associated with the condition.
METHODS
METHODS
The study is designed as a three-armed randomised controlled trial. Participants are randomly assigned to a) an established neurofeedback protocol for tinnitus (alpha/delta training), b) an active control group (beta/theta training) or c) a diary control group. In the 4-week intervention period, participants in both neurofeedback groups undergo 10 sessions, whereas participants in the diary control group complete a bi-weekly diary. The primary outcomes are between group differences in tinnitus sound perception change, as measured with the Tinnitus Magnitude Index (TMI), and changes in tinnitus distress, measured with the Tinnitus Handicap Inventory (THI), 4 weeks after the start of the intervention. Secondary outcome measures include changes in tinnitus distress, sleep quality, depressive symptoms and whether neurofeedback leads to specific power changes in the trained frequency bands.
DISCUSSION
CONCLUSIONS
This is the first randomised controlled trial examining the efficacy of an alpha/delta neurofeedback training protocol in reducing tinnitus sound perception and the distress associated with the condition. Compared to former studies, the present study is designed to assess both the specificity of an alpha/delta neurofeedback training protocol by including an active comparator and beta/theta neurofeedback training, in addition to controlling for placebo effects by the inclusion of a diary control group. This study aims to contribute to an understanding of the influences of both specific and non-specific effects in neurofeedback treatment for tinnitus.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov: NCT03550430. Registered on 27 May 2018.
Identifiants
pubmed: 32370767
doi: 10.1186/s13063-020-04309-y
pii: 10.1186/s13063-020-04309-y
pmc: PMC7201543
doi:
Banques de données
ClinicalTrials.gov
['NCT03550430']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
382Subventions
Organisme : Oticon Fonden
ID : 16-3805
Références
PLoS Med. 2005 Jun;2(6):e153
pubmed: 15971936
Psychosom Med. 2011 May;73(4):323-35
pubmed: 21536837
Am Psychol. 2017 Oct;72(7):679-688
pubmed: 29016171
Prog Brain Res. 2007;166:473-85
pubmed: 17956812
Clin Otolaryngol Allied Sci. 2001 Oct;26(5):388-93
pubmed: 11678946
N Engl J Med. 2002 Sep 19;347(12):904-10
pubmed: 12239260
Psychother Psychosom. 2015;84(4):193-207
pubmed: 26021883
J Cogn Neurosci. 2002 Apr 1;14(3):340-7
pubmed: 11970796
J Clin Neurophysiol. 1994 Jan;11(1):111-3
pubmed: 8195414
Sleep Med. 2001 Jul;2(4):297-307
pubmed: 11438246
J Am Acad Audiol. 2018 Nov/Dec;29(10):936-947
pubmed: 30479266
Front Aging Neurosci. 2017 Dec 01;9:386
pubmed: 29249959
J Am Acad Audiol. 1998 Apr;9(2):153-60
pubmed: 9564679
Ear Hear. 2012 Mar-Apr;33(2):153-76
pubmed: 22156949
Neural Plast. 2019 Mar 26;2019:3540898
pubmed: 31049052
Front Hum Neurosci. 2014 Oct 21;8:846
pubmed: 25374528
Neurosci Lett. 2010 Jul 19;479(1):49-53
pubmed: 20478360
Auris Nasus Larynx. 2011 Dec;38(6):735-8
pubmed: 21592701
Laryngorhinootologie. 2017 Sep;96(9):615-619
pubmed: 28499301
Internet Interv. 2016 Oct 03;6:107-114
pubmed: 30135819
Neurosci Biobehav Rev. 2006;30(6):730-48
pubmed: 16919333
J Commun Disord. 2007 Jul-Aug;40(4):313-34
pubmed: 17418230
Ann Otol Rhinol Laryngol. 1984 Jan-Feb;93(1 Pt 1):39-44
pubmed: 6367601
J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86
pubmed: 11132119
Yale J Biol Med. 2013 Sep 20;86(3):343-58
pubmed: 24058309
Front Hum Neurosci. 2016 Jun 17;10:301
pubmed: 27378892
Bull World Health Organ. 2001;79(4):373-4
pubmed: 11357217
Ear Hear. 2014 Jul-Aug;35(4):476-84
pubmed: 24603542
J Neural Transm (Vienna). 2011 Feb;118(2):275-84
pubmed: 21165661
Brain. 2017 Apr 1;140(4):862-864
pubmed: 28375458
Brain Res. 2017 May 15;1663:194-204
pubmed: 28315312
Sleep. 2011 May 01;34(5):601-8
pubmed: 21532953
BMJ. 2005 Apr 9;330(7495):843
pubmed: 15817555
BMC Med Res Methodol. 2013 Dec 06;13:150
pubmed: 24314204
N Engl J Med. 2012 Oct 4;367(14):1355-60
pubmed: 23034025
Am J Clin Hypn. 2007 Oct;50(2):177-82
pubmed: 18030929
Neuroimage. 2013 Jan 15;65:324-35
pubmed: 23022326
JAMA. 2016 Jan 26;315(4):407-8
pubmed: 26813213
Front Hum Neurosci. 2017 Mar 31;11:135
pubmed: 28408873
Cereb Cortex. 2005 Nov;15(11):1676-89
pubmed: 15703252
J Atten Disord. 2013 Jul;17(5):374-83
pubmed: 23086616
Eur Child Adolesc Psychiatry. 2019 Mar;28(3):293-305
pubmed: 29445867
Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8
pubmed: 8630207
Eur J Neurosci. 2010 Feb;31(4):770-8
pubmed: 20384819
Psychother Psychosom. 2009;78(5):275-84
pubmed: 19602916
Biol Psychol. 2014 Jan;95:108-15
pubmed: 24321363
Hear Res. 2016 Jul;337:70-9
pubmed: 27246985
Behav Res Methods. 2007 May;39(2):175-91
pubmed: 17695343
Eur Child Adolesc Psychiatry. 2017 May;26(5):573-582
pubmed: 27866283
Dialogues Clin Neurosci. 2013 Mar;15(1):109-19
pubmed: 23576894
J Psychosom Res. 2015 Mar;78(3):277-84
pubmed: 25582803
Clin Pharmacol Ther. 2012 Mar;91(3):550-4
pubmed: 22318615
Restor Neurol Neurosci. 2007;25(3-4):371-8
pubmed: 17943012
Gen Hosp Psychiatry. 2006 Jan-Feb;28(1):71-7
pubmed: 16377369
Front Hum Neurosci. 2014 Jul 24;8:555
pubmed: 25104932
Neuropsychologia. 1997 Jun;35(6):747-58
pubmed: 9204482
Brain. 2017 Oct 1;140(10):e63
pubmed: 28969378
J Gen Intern Med. 2001 Sep;16(9):606-13
pubmed: 11556941
Electroencephalogr Clin Neurophysiol. 1983 Apr;55(4):468-84
pubmed: 6187540