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Exploiting the Potential of Neural Attentional Control to Overcome Hearing Impairment (NeurAttContr)

Primary Purpose

Hearing Loss, Attention Impaired, Tinnitus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
tACS - transcranial alternating current stimulation
sham - transcranial alternating current stimulation
NF - Neurofeedback
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hearing Loss focused on measuring neuromodulation, auditory attention, neurobiology of language, electroencephalography, transcranial alternating current stimulation, neurofeedback, alpha oscillations, speech tracking

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm Type

No Intervention

No Intervention

No Intervention

No Intervention

No Intervention

Experimental

Sham Comparator

Experimental

Sham Comparator

Experimental

Sham Comparator

Experimental

Sham Comparator

Experimental

Sham Comparator

Experimental

Sham Comparator

Experimental

Active Comparator

Arm Label

Experiment 1 - Normal hearing - AAT

Experiment 1 - Hearing impaired - AAT

Experiment 2 - normal hearing _ SAT

Experiment 2 - hearing impaired - SAT

Experiment 2 - tinnitus - SAT

Experiment 3 - normal hearing (tACS) - AAT

Experiment 3 - normal hearing (sham) - AAT

Experiment 3 - hearing impaired (tACS) - AAT

Experiment 3 - hearing impaired (sham) - AAT

Experiment 3 - tinnitus (tACS) - AAT

Experiment 3 - tinnitus (sham) - AAT

Experiment 4 - normal hearing (tACS) - SAT

Experiment 4 - normal hearing (sham) - SAT

Experiment 4 - hearing impaired (tACS) - SAT

Experiment 4 - hearing impaired (sham) - SAT

Experiment 4 - tinnitus (tACS) - SAT

Experiment 4 - tinnitus (sham) - SAT

Experiment 5 - normal hearing (NF right) - AAT

Experiment 5 - normal hearing (NF left) - AAT

Arm Description

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).

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).

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).

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Experiment 1 - EEG
The primary endpoint is the comparison of neural alpha power lateralization in response to target selection and distractor suppression in individuals with HL, TI and a NH control group.
Experiment 2 - EEG
The primary endpoint is the comparison of the neural tracking of the amplitude envelope of speech between individuals with HL, TI and NH.
Experiment 3 - AAT
The primary endpoint is the comparison of auditory attention performance between tACS over the left temporo-parietal cortex, and an ineffective sham stimulation during and after stimulation relative to pre-stimulation baseline.
Experiment 4 - SAT
The primary endpoint is the comparison of speech comprehension performance between tACS over the left temporo-parietal cortex, and an ineffective sham stimulation during and after stimulation relative to pre-stimulation baseline.
Experiment 5 - EEG 1
The primary endpoint is the comparison of participants' ability to control alpha power lateralization index during training between training conditions (left NF training vs. right NF training).

Secondary Outcome Measures

Experiment 1 - AAT
To test whether alpha power lateralization during distractor suppression and target selection predicts AAT task performance in HL, TI, and NH individuals.
Experiment 2 - SAT
The relation between neural speech tracking and speech comprehension performance in NH, HL, and TI
Experiment 3 - EEG 1
Comparison of neural alpha power lateralization between stimulation conditions (tACS vs. sham)
Experiment 3 - EEG 2
Comparison of event-related responses to target and distractor stimuli between stimulation conditions (tACS vs. sham)
Experiment 4 - EEG 1
Comparison of lateralization index between stimulation conditions (tACS vs. sham)
Experiment 4 - EEG 2
Comparison between neural tracking of target and distracting speech between stimulation conditions (tACS vs. sham)
Experiment 5 - EEG 2
Comparison of auditory evoked responses to probes presented ipsilateral vs. contralateral to the trained hemisphere
Experiment 5 - EEG 3
Comparison of changes in target and distractor related alpha power lateralization between NF training conditions (left NF training vs. right NF training) pre- vs post NF Training
Experiment 5 - AAT
Comparison of auditory attention performance across training conditions (left NF training vs. right NF training)

Full Information

First Posted
August 17, 2022
Last Updated
May 11, 2023
Sponsor
University of Zurich
Collaborators
University of Luebeck
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1. Study Identification

Unique Protocol Identification Number
NCT05513352
Brief Title
Exploiting the Potential of Neural Attentional Control to Overcome Hearing Impairment
Acronym
NeurAttContr
Official Title
Exploiting the Potential of Neural Attentional Control to Overcome Hearing Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
University of Luebeck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Attention Impaired, Tinnitus
Keywords
neuromodulation, auditory attention, neurobiology of language, electroencephalography, transcranial alternating current stimulation, neurofeedback, alpha oscillations, speech tracking

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
single-blind
Allocation
Randomized
Enrollment
275 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiment 1 - Normal hearing - AAT
Arm Type
No Intervention
Arm Description
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).
Arm Title
Experiment 1 - Hearing impaired - AAT
Arm Type
No Intervention
Arm Description
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).
Arm Title
Experiment 2 - normal hearing _ SAT
Arm Type
No Intervention
Arm Description
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).
Arm Title
Experiment 2 - hearing impaired - SAT
Arm Type
No Intervention
Arm Description
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).
Arm Title
Experiment 2 - tinnitus - SAT
Arm Type
No Intervention
Arm Description
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).
Arm Title
Experiment 3 - normal hearing (tACS) - AAT
Arm Type
Experimental
Arm Description
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.
Arm Title
Experiment 3 - normal hearing (sham) - AAT
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Experiment 3 - hearing impaired (tACS) - AAT
Arm Type
Experimental
Arm Description
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.
Arm Title
Experiment 3 - hearing impaired (sham) - AAT
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Experiment 3 - tinnitus (tACS) - AAT
Arm Type
Experimental
Arm Description
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.
Arm Title
Experiment 3 - tinnitus (sham) - AAT
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Experiment 4 - normal hearing (tACS) - SAT
Arm Type
Experimental
Arm Description
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.
Arm Title
Experiment 4 - normal hearing (sham) - SAT
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Experiment 4 - hearing impaired (tACS) - SAT
Arm Type
Experimental
Arm Description
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.
Arm Title
Experiment 4 - hearing impaired (sham) - SAT
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Experiment 4 - tinnitus (tACS) - SAT
Arm Type
Experimental
Arm Description
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.
Arm Title
Experiment 4 - tinnitus (sham) - SAT
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Experiment 5 - normal hearing (NF right) - AAT
Arm Type
Experimental
Arm Description
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.
Arm Title
Experiment 5 - normal hearing (NF left) - AAT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
tACS - transcranial alternating current stimulation
Intervention Description
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
Intervention Name(s)
sham - transcranial alternating current stimulation
Intervention Description
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
Intervention Name(s)
NF - Neurofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Experiment 1 - EEG
Description
The primary endpoint is the comparison of neural alpha power lateralization in response to target selection and distractor suppression in individuals with HL, TI and a NH control group.
Time Frame
One study session of 4 hours and 40 minutes
Title
Experiment 2 - EEG
Description
The primary endpoint is the comparison of the neural tracking of the amplitude envelope of speech between individuals with HL, TI and NH.
Time Frame
One study session of 4 hours and 40 minutes
Title
Experiment 3 - AAT
Description
The primary endpoint is the comparison of auditory attention performance between tACS over the left temporo-parietal cortex, and an ineffective sham stimulation during and after stimulation relative to pre-stimulation baseline.
Time Frame
One study session of 4 hours and 40 minutes
Title
Experiment 4 - SAT
Description
The primary endpoint is the comparison of speech comprehension performance between tACS over the left temporo-parietal cortex, and an ineffective sham stimulation during and after stimulation relative to pre-stimulation baseline.
Time Frame
One study session of 4 hours and 40 minutes
Title
Experiment 5 - EEG 1
Description
The primary endpoint is the comparison of participants' ability to control alpha power lateralization index during training between training conditions (left NF training vs. right NF training).
Time Frame
two sessions of 4 hours and 40 minutes on separate days
Secondary Outcome Measure Information:
Title
Experiment 1 - AAT
Description
To test whether alpha power lateralization during distractor suppression and target selection predicts AAT task performance in HL, TI, and NH individuals.
Time Frame
One study session of 4 hours and 40 minutes
Title
Experiment 2 - SAT
Description
The relation between neural speech tracking and speech comprehension performance in NH, HL, and TI
Time Frame
One study session of 4 hours and 40 minutes
Title
Experiment 3 - EEG 1
Description
Comparison of neural alpha power lateralization between stimulation conditions (tACS vs. sham)
Time Frame
One study session of 4 hours and 40 minutes
Title
Experiment 3 - EEG 2
Description
Comparison of event-related responses to target and distractor stimuli between stimulation conditions (tACS vs. sham)
Time Frame
One study session of 4 hours and 40 minutes
Title
Experiment 4 - EEG 1
Description
Comparison of lateralization index between stimulation conditions (tACS vs. sham)
Time Frame
One study session of 4 hours and 40 minutes
Title
Experiment 4 - EEG 2
Description
Comparison between neural tracking of target and distracting speech between stimulation conditions (tACS vs. sham)
Time Frame
One study session of 4 hours and 40 minutes
Title
Experiment 5 - EEG 2
Description
Comparison of auditory evoked responses to probes presented ipsilateral vs. contralateral to the trained hemisphere
Time Frame
two sessions of 4 hours and 40 minutes on separate days
Title
Experiment 5 - EEG 3
Description
Comparison of changes in target and distractor related alpha power lateralization between NF training conditions (left NF training vs. right NF training) pre- vs post NF Training
Time Frame
two sessions of 4 hours and 40 minutes on separate days
Title
Experiment 5 - AAT
Description
Comparison of auditory attention performance across training conditions (left NF training vs. right NF training)
Time Frame
two sessions of 4 hours and 40 minutes on separate days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Basil Preisig, Dr.
Phone
+41 44 634 21 85
Email
basil.preisig@uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Basil Preisig, Dr.
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Zurich
City
Zürich
ZIP/Postal Code
8090
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Basil Preisig, Dr.
Email
basil.preisig@uzh.ch
First Name & Middle Initial & Last Name & Degree
Anouk Glättli, Msc.
Email
anouk.glaettli@uzh.ch

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators intend to share the raw data of the included participants and the analysis code.
IPD Sharing Time Frame
after the project is completed
IPD Sharing Access Criteria
upon personal request

Learn more about this trial

Exploiting the Potential of Neural Attentional Control to Overcome Hearing Impairment

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