Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05737888
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2023-02-10
Brief Title:
Physiological Regulation of Chronic Tinnitus
Sponsor:
Wyss Center for Bio and Neuroengineering
Organization:
Wyss Center for Bio and Neuroengineering
Study Overview
Official Title:
Physiological Regulation of Chronic Tinnitus
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeuroTin
Brief Summary:
The present project involves research on humans with the aim to characterize the reduction of chronic continuous non-pulsatile and debilitating tinnitus in humans by comparing neurofeedback fMRI or EEG to the current gold standard behavioral cognitive therapy
Detailed Description:
Chronic tinnitus is affecting 10-15 of people typically for many decades with increasing prevalence with aging Multiple therapy forms for tinnitus exist including cognitive behavioral therapy external white noise stimulation meditation and various kinds of alternative approaches but up to now no generally accepted successful treatment exists Previously it was shown that voluntary control of the activation of the auditory cortex can be learned by means of real-time functional Magnetic Resonance Imaging fMRI neurofeedback and that it may alleviate tinnitus symptoms The same seems to hold for learned increase of alpha activity localized in the auditory cortex through electroencephalography EEG neurofeedback Given the high prevalence of chronic tinnitus its significant burden for affected individuals and given the absence of generally effective therapy neurofeedback training for tinnitus has the potential to become a clinical application
The main goal of this project is to comparatively assess tinnitus reduction using neurofeedback fMRI or EEG compared to cognitive behavioral therapy in participants with chronic severe tinnitus
The participants are assigned to 3 different experimental groups EEG neurofeedback fMRI neurofeedback or cognitive behavioral therapy The participation per subject will last from 4 to 12 months
The participants undergo medical tests including audiological tests as well as questionnaires related to tinnitus and quality of life at different timepoints of the study pre and post training visits
At the end of the experimental visits each participant will have one early and one late post-assessment evaluation visits
In order to evaluate the longer-term evolution of tinnitus over time long-term follow-ups will be scheduled starting at 9 months after the final experimental visit and will occur every 45 months thereafter until research ends for a maximum of 5 years
The main goal of this project is to comparatively assess tinnitus reduction using neurofeedback fMRI or EEG compared to cognitive behavioral therapy in participants with chronic severe tinnitus
The participants are assigned to 3 different experimental groups EEG neurofeedback fMRI neurofeedback or cognitive behavioral therapy The participation per subject will last from 4 to 12 months
The participants undergo medical tests including audiological tests as well as questionnaires related to tinnitus and quality of life at different timepoints of the study pre and post training visits
At the end of the experimental visits each participant will have one early and one late post-assessment evaluation visits
In order to evaluate the longer-term evolution of tinnitus over time long-term follow-ups will be scheduled starting at 9 months after the final experimental visit and will occur every 45 months thereafter until research ends for a maximum of 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None