Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520865
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
TIDE Project Biomarker Discovery for Chronic Tinnitus Diagnosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Identification and Validation of a Biomarker for Tinnitus an Objective Data-driven Personalized Approach to Diagnosis of Chronic Tinnitus - The Tinnitus Detection TIDE Project
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIDE
Brief Summary:
Research in clinical neuroscience is founded on the conviction that a better understanding of tinnitus related changes of brain function will improve our ability to diagnose and treat tinnitus Although considerable advances have been made in understanding the mechanisms of tinnitus the clinical management of tinnitus remains largely based on a trial and error approach The identification and validation of a biomarker for tinnitus is thought to be the crucial step in the development of a personalized approach to the diagnosis and treatment of tinnitus The overarching goal of this study is to incorporate advanced technologies to provide an objective data-driven personalized approach to the diagnosis of chronic tinnitus This should lead to a clinically applicable tool that can be widely and easily used
Detailed Description:
The tinnitus detect TIDE consortium has been designed to identify and validate a biomarker for the presence and intensity of tinnitus For this purpose two test paradigms are combined which are derived from the most recent models of tinnitus and which have shown promise in pilot studies
A first approach is based on a method used in animals to objectively assess tinnitus by gap detection namely Gap prepulse inhibition of the acoustic startle GPIAS The GPIAS paradigm is inspired from the combination of both gap detection and pre-pulse inhibition PPI used for the assessment of temporal sensory processing in both animals and humans The basic principle of PPI relies on the ability of a weak lead stimulus a prepulse or a silent gap presented in a carrier background to inhibit a startling effect of a following more intense abrupt stimulus These paradigms have been used to assess the automatic or preconscious inhibition of the motor reflex response that occurs in healthy subjects Because GPIAS is regulated at the level of the auditory cortex cortical responses may provide a more accurate measure of inhibition than motor reflex responses such as the startle response in animals or the eye blinking in humans The hypothesis is that individuals with tinnitus would have impaired inhibition of cortical evoked responses to sound pulses when preceded by a silent gap in comparison to non-tinnitus individuals due to the ongoing tinnitus percept
A second approach is based on the concept that tinnitus occurrence is related to altered processing of prediction errors This concept is supported by empirical evidence demonstrating that people with tinnitus exhibit a more pronounced electrophysiological response to a mismatch between predictions the expected sound based on the auditory training paradigm and perceptions as compared to non-tinnitus individuals This sensitivity to prediction errors the difference between prediction and input is associated with how loud patients perceive their tinnitus independent of co-occurring hyperacusis and hearing loss For example the amplitude of the mismatch negativity MMN positively correlates with subjectively reported tinnitus loudness Thus the MMN might be a biomarker for how loud tinnitus patients perceive their tinnitus That is people with a more pronounced electrophysiological response to a prediction error perceive a louder phantom sound Using another paradigm a group independent of us confirmed the importance of the MMN for tinnitus detection Furthermore an increase in amplitude and a delay in latency for the late positive evoked brain response P300 has been demonstrated in tinnitus patients using both auditory and visual oddball paradigms Both the MMN and P300 are conceived as measures of prediction errors identified at respectively the sensory cortex and higher levels ie frontal-parietal cortex The P300 is thought to reflect processes involved in stimulus evaluation or categorization whether the stimulus is behaviourally relevant or not Therefore the aim of the current approach is to validate that both the MMN and the P300 using an auditory oddball paradigm with omission can be used as biomarkers for tinnitus loudness and presence respectively ie cross-validation
We propose to investigate these two paradigms in a large international sample of tinnitus patients and controls in order to determine the sensitivity of GPIAS and the oddball paradigm in diagnosing tinnitus in humans
A first approach is based on a method used in animals to objectively assess tinnitus by gap detection namely Gap prepulse inhibition of the acoustic startle GPIAS The GPIAS paradigm is inspired from the combination of both gap detection and pre-pulse inhibition PPI used for the assessment of temporal sensory processing in both animals and humans The basic principle of PPI relies on the ability of a weak lead stimulus a prepulse or a silent gap presented in a carrier background to inhibit a startling effect of a following more intense abrupt stimulus These paradigms have been used to assess the automatic or preconscious inhibition of the motor reflex response that occurs in healthy subjects Because GPIAS is regulated at the level of the auditory cortex cortical responses may provide a more accurate measure of inhibition than motor reflex responses such as the startle response in animals or the eye blinking in humans The hypothesis is that individuals with tinnitus would have impaired inhibition of cortical evoked responses to sound pulses when preceded by a silent gap in comparison to non-tinnitus individuals due to the ongoing tinnitus percept
A second approach is based on the concept that tinnitus occurrence is related to altered processing of prediction errors This concept is supported by empirical evidence demonstrating that people with tinnitus exhibit a more pronounced electrophysiological response to a mismatch between predictions the expected sound based on the auditory training paradigm and perceptions as compared to non-tinnitus individuals This sensitivity to prediction errors the difference between prediction and input is associated with how loud patients perceive their tinnitus independent of co-occurring hyperacusis and hearing loss For example the amplitude of the mismatch negativity MMN positively correlates with subjectively reported tinnitus loudness Thus the MMN might be a biomarker for how loud tinnitus patients perceive their tinnitus That is people with a more pronounced electrophysiological response to a prediction error perceive a louder phantom sound Using another paradigm a group independent of us confirmed the importance of the MMN for tinnitus detection Furthermore an increase in amplitude and a delay in latency for the late positive evoked brain response P300 has been demonstrated in tinnitus patients using both auditory and visual oddball paradigms Both the MMN and P300 are conceived as measures of prediction errors identified at respectively the sensory cortex and higher levels ie frontal-parietal cortex The P300 is thought to reflect processes involved in stimulus evaluation or categorization whether the stimulus is behaviourally relevant or not Therefore the aim of the current approach is to validate that both the MMN and the P300 using an auditory oddball paradigm with omission can be used as biomarkers for tinnitus loudness and presence respectively ie cross-validation
We propose to investigate these two paradigms in a large international sample of tinnitus patients and controls in order to determine the sensitivity of GPIAS and the oddball paradigm in diagnosing tinnitus in humans
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None