Exploiting the Potential of Neural Attentional Control to Overcome Hearing Impairment
NCT ID: NCT05513352
Last Updated: 2023-12-07
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
275 participants
INTERVENTIONAL
2023-11-01
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
* 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
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Luebeck
OTHER
University of Zurich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Basil Preisig, Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Zurich
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Basil Preisig, Dr.
Role: primary
Nataliya Fartdinova, MA
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201864
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AuditoryAttention
Identifier Type: -
Identifier Source: org_study_id