Exploiting the Potential of Neural Attentional Control to Overcome Hearing Impairment

NCT ID: NCT05513352

Last Updated: 2023-12-07

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-04-30

Brief Summary

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This study will improve the understanding of the cerebral mechanisms that underlie the control of auditory selective attention and evaluate the potential of neuromodulation to enhance neural attention control as a possible way to overcome hearing impairment.

First, electroencephalography (EEG) will be applied to identify neural marker of auditory attention in individuals with hearing loss (HL), tinnitus (TI) and normal hearing (NH). Afterwards, the importance of the identified markers for attention control will be tested using non-invasive transcranial alternating current stimulation (tACS) and neurofeedback (NF).

Detailed Description

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Hearing loss and associated conditions such as tinnitus are the fourth highest cause of disability worldwide, with estimated annual cost of over 750 billion dollars. Due to the rise and ageing of the global population, the number of people with hearing impairment is growing at a rapid pace. Besides, the incidence of noise induced hearing impairment is also increasing in younger populations. A common complaint of hearing impaired individuals is the significant decline of speech comprehension under challenging listening conditions. These situations typically include reverberations, background noise or multiple speakers and they require the listener to direct attention selectively to a target sound source (e.g. the interlocutor) and to suppress distracting sounds in the background (e.g. from not attended speakers).

Auditory prostheses with pinna-imitating microphones can improve the localization of a target sound source through the sensory enhancement of spatial cues in the acoustic signal. However, the benefit of additional sensory information is limited due of the missing implementation of attention control that would permit the selective amplification of the target sound source and the suppression of irrelevant distracting noise.

The question of how the brain instantiates attentional filter mechanisms that control target amplification and distractor suppression has drawn a lot of interest in the field of cognitive neuroscience. Neural markers of auditory attention such as lateralized oscillatory brain activity in the alpha frequency band (\~8-12Hz) and the enhanced neural tracking of attended of attended speech have been linked to the top-down control of attention. However, the interrelationship between these neural markers is still underexplored. Further, the functional role of alpha band oscillations in auditory attention is underspecified as they could potentially implement target enhancement and distractor suppression. Together, this limits the understanding of the neuro-cognitive basis of attention.

The proposed project aims to address this problem by improving the investigators understanding of the cerebral mechanisms that underlie the control of auditory selective attention. The outlined research project will test the hypothesis that individuals with hearing impairment have deficits in auditory distractor inhibition that are reflected by ineffective neural suppression of irrelevant information. This hypothesis will be examined in three different lines of research. In research line 1, I will test a new framework in individuals who suffer from sensorineural hearing loss or tinnitus that allows to dissociate target selection and distractor suppression at the neural level based on electroencephalography (EEG) recordings. In research lines 2-3, I will then evaluate the potential of electric brain stimulation and neurofeedback to enhance auditory distractor suppression.The results of this project will have theoretical implications for current models of auditory attention and speech comprehension by specifying the functional role of oscillatory brain activity in normal hearing individual and hearing impaired populations. Beyond, this research will contribute new insights how the control of auditory selective attention could be implemented in a brain-computer interface.

Conditions

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Hearing Loss Attention Impaired Tinnitus

Keywords

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neuromodulation auditory attention neurobiology of language electroencephalography transcranial alternating current stimulation neurofeedback alpha oscillations speech tracking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experiment 1:

* between-subject design
* 3x4 = 3(hearing group) x 4(condition)
* Masking: Single (Participant)
* Masking Description: single-blind

Experiment 2:

* between-subject design
* 3x4 = 3(hearing group) x 4(condition)
* Masking: Single (Participant)
* Masking Description: single-blind

Experiment 3:

* between-subject design
* 3x2x2x4 = 3(hearing group) x 2 (stimulation) x 2(timepoint) x 4(condition)
* Masking: Double (Participant, investigator)
* Masking Description: double-blind

Experiment 4:

* between-subject design
* 3x2x2x4 = 3(hearing group) x 2 (stimulation) x 2(timepoint) x 4(condition)
* Masking: Double (Participant, investigator)
* Masking Description: double-blind

Experiment 5:

* within-subject design
* 2x2x4 = 2 (training) x 2(timepoint) x 4(condition)
* Masking: Double (Participant, investigator)
* Masking Description: double-blind

Primary Purpose: Basic Science
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
single-blind

Study Groups

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Experiment 1 - Normal hearing - AAT

Each participant assigned to the normal hearing group will undergo one experimental session during which EEG is recorded while participants perform an auditory attention task (AAT).

Group Type NO_INTERVENTION

No interventions assigned to this group

Experiment 1 - Hearing impaired - AAT

Each participant assigned to the normal hearing impaired group will undergo one experimental session during which EEG is recorded while participants perform an auditory attention task (AAT).

Group Type NO_INTERVENTION

No interventions assigned to this group

Experiment 2 - normal hearing _ SAT

Each participant assigned to the normal hearing group will undergo one experimental session in which EEG is used to measure neural speech tracking while participants undergo the selective speech attention task (SAT).

Group Type NO_INTERVENTION

No interventions assigned to this group

Experiment 2 - hearing impaired - SAT

Each participant assigned to the hearing impaired group will undergo one experimental session in which EEG is used to measure neural speech tracking while participants undergo the selective speech attention task (SAT).

Group Type NO_INTERVENTION

No interventions assigned to this group

Experiment 2 - tinnitus - SAT

Each participant assigned to the tinnitus group will undergo one experimental session in which EEG is used to measure neural speech tracking while participants undergo the selective speech attention task (SAT).

Group Type NO_INTERVENTION

No interventions assigned to this group

Experiment 3 - normal hearing (tACS) - AAT

The subjects assigned to the normal hearing group will undertake 20min tACS stimulation applied over the temporo-parietal cortex.

Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded.

Group Type EXPERIMENTAL

tACS - transcranial alternating current stimulation

Intervention Type DEVICE

TACS is a non-invasive brain stimulation (NIBS) techniques that belong to the class of low current transcranial electric stimulation. In contrast to the better known transcranial direct current stimulation (tDCS), the tACS current is not constant, but alternates with a certain frequency.

The stimulation will be applied over the left temporo-parietal cortex at participants' individual alpha frequency. The stimulation intensity will be 2 milliampere (mA, peak-to-peak value, corresponding to a sine wave of ±1 mA amplitude). Stimulation will be delivered through conductive rubber electrodes.

Experiment 3 - normal hearing (sham) - AAT

The subjects assigned to the normal hearing group will undertake 20min sham stimulation applied over the temporo-parietal cortex.

Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded.

Group Type SHAM_COMPARATOR

sham - transcranial alternating current stimulation

Intervention Type DEVICE

During "sham stimulation" (placebo), tACS will be ramped up and down for 12 seconds , that is, no electric stimulation wil be applied during the actual experiment. The up and down ramping will be repeated at the end of the experiment.

The sham condition serves to evoke sensations associated with tACS stimulation, but without stimulating during the actual experiment.

Experiment 3 - hearing impaired (tACS) - AAT

The subjects assigned to the hearing impaired group will undertake 20min tACS stimulation applied over the temporo-parietal cortex.

Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded.

Group Type EXPERIMENTAL

tACS - transcranial alternating current stimulation

Intervention Type DEVICE

TACS is a non-invasive brain stimulation (NIBS) techniques that belong to the class of low current transcranial electric stimulation. In contrast to the better known transcranial direct current stimulation (tDCS), the tACS current is not constant, but alternates with a certain frequency.

The stimulation will be applied over the left temporo-parietal cortex at participants' individual alpha frequency. The stimulation intensity will be 2 milliampere (mA, peak-to-peak value, corresponding to a sine wave of ±1 mA amplitude). Stimulation will be delivered through conductive rubber electrodes.

Experiment 3 - hearing impaired (sham) - AAT

The subjects assigned to the hearing impaired group will undertake 20min sham stimulation applied over the temporo-parietal cortex.

Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded.

Group Type SHAM_COMPARATOR

sham - transcranial alternating current stimulation

Intervention Type DEVICE

During "sham stimulation" (placebo), tACS will be ramped up and down for 12 seconds , that is, no electric stimulation wil be applied during the actual experiment. The up and down ramping will be repeated at the end of the experiment.

The sham condition serves to evoke sensations associated with tACS stimulation, but without stimulating during the actual experiment.

Experiment 3 - tinnitus (tACS) - AAT

The subjects assigned to the tinnitus group will undertake 20min tACS stimulation applied over the temporo-parietal cortex.

Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded.

Group Type EXPERIMENTAL

tACS - transcranial alternating current stimulation

Intervention Type DEVICE

TACS is a non-invasive brain stimulation (NIBS) techniques that belong to the class of low current transcranial electric stimulation. In contrast to the better known transcranial direct current stimulation (tDCS), the tACS current is not constant, but alternates with a certain frequency.

The stimulation will be applied over the left temporo-parietal cortex at participants' individual alpha frequency. The stimulation intensity will be 2 milliampere (mA, peak-to-peak value, corresponding to a sine wave of ±1 mA amplitude). Stimulation will be delivered through conductive rubber electrodes.

Experiment 3 - tinnitus (sham) - AAT

The subjects assigned to the tinnitus group will undertake 20min sham stimulation applied over the temporo-parietal cortex.

Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. AAT will be conducted in each phase and concurrent EEG will be recorded.

Group Type SHAM_COMPARATOR

sham - transcranial alternating current stimulation

Intervention Type DEVICE

During "sham stimulation" (placebo), tACS will be ramped up and down for 12 seconds , that is, no electric stimulation wil be applied during the actual experiment. The up and down ramping will be repeated at the end of the experiment.

The sham condition serves to evoke sensations associated with tACS stimulation, but without stimulating during the actual experiment.

Experiment 4 - normal hearing (tACS) - SAT

The subjects assigned to the normal hearing group will undertake 20min tACS stimulation applied over the temporo-parietal cortex.

Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded.

Group Type EXPERIMENTAL

tACS - transcranial alternating current stimulation

Intervention Type DEVICE

TACS is a non-invasive brain stimulation (NIBS) techniques that belong to the class of low current transcranial electric stimulation. In contrast to the better known transcranial direct current stimulation (tDCS), the tACS current is not constant, but alternates with a certain frequency.

The stimulation will be applied over the left temporo-parietal cortex at participants' individual alpha frequency. The stimulation intensity will be 2 milliampere (mA, peak-to-peak value, corresponding to a sine wave of ±1 mA amplitude). Stimulation will be delivered through conductive rubber electrodes.

Experiment 4 - normal hearing (sham) - SAT

The subjects assigned to the normal hearing group will undertake 20min sham stimulation applied over the temporo-parietal cortex.

Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded.

Group Type SHAM_COMPARATOR

sham - transcranial alternating current stimulation

Intervention Type DEVICE

During "sham stimulation" (placebo), tACS will be ramped up and down for 12 seconds , that is, no electric stimulation wil be applied during the actual experiment. The up and down ramping will be repeated at the end of the experiment.

The sham condition serves to evoke sensations associated with tACS stimulation, but without stimulating during the actual experiment.

Experiment 4 - hearing impaired (tACS) - SAT

The subjects assigned to the hearing impaired group will undertake 20min tACS stimulation applied over the temporo-parietal cortex.

Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded.

Group Type EXPERIMENTAL

tACS - transcranial alternating current stimulation

Intervention Type DEVICE

TACS is a non-invasive brain stimulation (NIBS) techniques that belong to the class of low current transcranial electric stimulation. In contrast to the better known transcranial direct current stimulation (tDCS), the tACS current is not constant, but alternates with a certain frequency.

The stimulation will be applied over the left temporo-parietal cortex at participants' individual alpha frequency. The stimulation intensity will be 2 milliampere (mA, peak-to-peak value, corresponding to a sine wave of ±1 mA amplitude). Stimulation will be delivered through conductive rubber electrodes.

Experiment 4 - hearing impaired (sham) - SAT

The subjects assigned to the hearing impaired group will undertake 20min sham stimulation applied over the temporo-parietal cortex.

Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded.

Group Type SHAM_COMPARATOR

sham - transcranial alternating current stimulation

Intervention Type DEVICE

During "sham stimulation" (placebo), tACS will be ramped up and down for 12 seconds , that is, no electric stimulation wil be applied during the actual experiment. The up and down ramping will be repeated at the end of the experiment.

The sham condition serves to evoke sensations associated with tACS stimulation, but without stimulating during the actual experiment.

Experiment 4 - tinnitus (tACS) - SAT

The subjects assigned to the tinnitus group will undertake 20min tACS stimulation applied over the temporo-parietal cortex.

Each session will include the following three phases: (1) pre-stimulation baseline, (2) brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded.

Group Type EXPERIMENTAL

tACS - transcranial alternating current stimulation

Intervention Type DEVICE

TACS is a non-invasive brain stimulation (NIBS) techniques that belong to the class of low current transcranial electric stimulation. In contrast to the better known transcranial direct current stimulation (tDCS), the tACS current is not constant, but alternates with a certain frequency.

The stimulation will be applied over the left temporo-parietal cortex at participants' individual alpha frequency. The stimulation intensity will be 2 milliampere (mA, peak-to-peak value, corresponding to a sine wave of ±1 mA amplitude). Stimulation will be delivered through conductive rubber electrodes.

Experiment 4 - tinnitus (sham) - SAT

The subjects assigned to the tinnitus group will undertake 20min sham stimulation applied over the temporo-parietal cortex.

Each session will include the following three phases: (1) pre-stimulation baseline, (2) sham brain stimulation, and (3) post-stimulation. SAT will be conducted in each phase and concurrent EEG will be recorded.

Group Type SHAM_COMPARATOR

sham - transcranial alternating current stimulation

Intervention Type DEVICE

During "sham stimulation" (placebo), tACS will be ramped up and down for 12 seconds , that is, no electric stimulation wil be applied during the actual experiment. The up and down ramping will be repeated at the end of the experiment.

The sham condition serves to evoke sensations associated with tACS stimulation, but without stimulating during the actual experiment.

Experiment 5 - normal hearing (NF right) - AAT

Each participant of the normal hearing group will undergo the neurofeedback training in which the participants learn to increase alpha power in the right relative to the left parietal cortex. Before and after the NF training, participants will perform the AAT and concurrent EEG will be recorded.

Group Type EXPERIMENTAL

NF - Neurofeedback

Intervention Type DEVICE

Neurofeedback (NF) is a non-invasive approach that combines neurophysiological recordings with real-time sensory feedback (most studies use visual feedback). Through real-time NF, individuals thus can learn to regulate their brain activity.

In this study, NF will be based on concurrent EEG recordings. During NF, participants will observe a space ship automatically navigating through a narrow tunnel. The modulation of their neural alpha power lateralization into the trained direction will be rewarded by the acceleration of the space ship, a modulation in the opposite direction will reduce speed and autopilot accuracy.

Experiment 5 - normal hearing (NF left) - AAT

Each participant of the normal hearing group will undergo the neurofeedback training in which the participants learn to increase alpha power in the left relative to the right parietal cortex. Before and after the NF training, participants will perform the AAT and concurrent EEG will be recorded.

Group Type ACTIVE_COMPARATOR

NF - Neurofeedback

Intervention Type DEVICE

Neurofeedback (NF) is a non-invasive approach that combines neurophysiological recordings with real-time sensory feedback (most studies use visual feedback). Through real-time NF, individuals thus can learn to regulate their brain activity.

In this study, NF will be based on concurrent EEG recordings. During NF, participants will observe a space ship automatically navigating through a narrow tunnel. The modulation of their neural alpha power lateralization into the trained direction will be rewarded by the acceleration of the space ship, a modulation in the opposite direction will reduce speed and autopilot accuracy.

Interventions

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tACS - transcranial alternating current stimulation

TACS is a non-invasive brain stimulation (NIBS) techniques that belong to the class of low current transcranial electric stimulation. In contrast to the better known transcranial direct current stimulation (tDCS), the tACS current is not constant, but alternates with a certain frequency.

The stimulation will be applied over the left temporo-parietal cortex at participants' individual alpha frequency. The stimulation intensity will be 2 milliampere (mA, peak-to-peak value, corresponding to a sine wave of ±1 mA amplitude). Stimulation will be delivered through conductive rubber electrodes.

Intervention Type DEVICE

sham - transcranial alternating current stimulation

During "sham stimulation" (placebo), tACS will be ramped up and down for 12 seconds , that is, no electric stimulation wil be applied during the actual experiment. The up and down ramping will be repeated at the end of the experiment.

The sham condition serves to evoke sensations associated with tACS stimulation, but without stimulating during the actual experiment.

Intervention Type DEVICE

NF - Neurofeedback

Neurofeedback (NF) is a non-invasive approach that combines neurophysiological recordings with real-time sensory feedback (most studies use visual feedback). Through real-time NF, individuals thus can learn to regulate their brain activity.

In this study, NF will be based on concurrent EEG recordings. During NF, participants will observe a space ship automatically navigating through a narrow tunnel. The modulation of their neural alpha power lateralization into the trained direction will be rewarded by the acceleration of the space ship, a modulation in the opposite direction will reduce speed and autopilot accuracy.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age: 18-35 / 55-75
* German as first language
* Normal or corrected to normal vision
* Right-handed
* Normal hearing, hearing impairment or tinnitus (see specified inclusion)
* Normal hearing: ≤20 decibel (dB) hearing level (HL) at frequencies from 250 Hz to 8,000 Hz for both ears.

Specified inclusion for Experiment 1, 2, 3 \& 4:

* Hearing loss:
* bilateral symmetrical sensorineural hearing loss
* pure tone thresholds of ≥25 dB HL at one or more frequencies between 250 Hz and 8,000 Hz and differences in thresholds across the two ears of ≤20 dB at every frequency.
* Tinnitus:
* Persistent chronic tinnitus with duration of more than 3 months
* Tinnitus with a Tinnitus Handicap Inventory Grade 2 to 4 (18-76 points)

Exclusion Criteria

* Non-symmetrical hearing loss
* Raised bi- or multilingually (second language acquired earlier than 6 years of age)
* Women who are currently pregnant or breastfeeding
* History of brain injury or any neurological disorder (y/n)

• For example, stroke, traumatic brain injury, brain surgery, epilepsy etc.
* Dyslexia
* History of psychiatric disorder
* Recent recreational drug consumption
* Known or suspected drug or alcohol abuse
* Medication with cognitive side effects (e.g., psychoactive medications or sleeping pills)
* Metallic implants in the head region (excluding fixed braces and tooth fillings)
* Any implanted medical device (e.g., cardiac pacemakers)
* Previous enrolment in one of the experiments comprising the main investigational plan
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Luebeck

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Basil Preisig, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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University of Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Basil Preisig, Dr.

Role: CONTACT

Phone: +41 44 634 21 85

Email: [email protected]

Facility Contacts

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Basil Preisig, Dr.

Role: primary

Nataliya Fartdinova, MA

Role: backup

Other Identifiers

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201864

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AuditoryAttention

Identifier Type: -

Identifier Source: org_study_id