Exploiting the Potential of Neural Attentional Control to Overcome Hearing Impairment
NeurAttContr
2 other identifiers
interventional
275
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2022
CompletedFirst Posted
Study publicly available on registry
August 24, 2022
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedDecember 7, 2023
November 1, 2023
2.4 years
August 17, 2022
November 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
One study session of 4 hours and 40 minutes
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.
One study session of 4 hours and 40 minutes
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.
One study session of 4 hours and 40 minutes
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.
One study session of 4 hours and 40 minutes
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).
two sessions of 4 hours and 40 minutes on separate days
Secondary Outcomes (9)
Experiment 1 - AAT
One study session of 4 hours and 40 minutes
Experiment 2 - SAT
One study session of 4 hours and 40 minutes
Experiment 3 - EEG 1
One study session of 4 hours and 40 minutes
Experiment 3 - EEG 2
One study session of 4 hours and 40 minutes
Experiment 4 - EEG 1
One study session of 4 hours and 40 minutes
- +4 more secondary outcomes
Study Arms (19)
Experiment 1 - Normal hearing - AAT
NO INTERVENTIONEach 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).
Experiment 1 - Hearing impaired - AAT
NO INTERVENTIONEach 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).
Experiment 2 - normal hearing _ SAT
NO INTERVENTIONEach 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).
Experiment 2 - hearing impaired - SAT
NO INTERVENTIONEach 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).
Experiment 2 - tinnitus - SAT
NO INTERVENTIONEach 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).
Experiment 3 - normal hearing (tACS) - AAT
EXPERIMENTALThe 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.
Experiment 3 - normal hearing (sham) - AAT
SHAM COMPARATORThe 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.
Experiment 3 - hearing impaired (tACS) - AAT
EXPERIMENTALThe 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.
Experiment 3 - hearing impaired (sham) - AAT
SHAM COMPARATORThe 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.
Experiment 3 - tinnitus (tACS) - AAT
EXPERIMENTALThe 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.
Experiment 3 - tinnitus (sham) - AAT
SHAM COMPARATORThe 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.
Experiment 4 - normal hearing (tACS) - SAT
EXPERIMENTALThe 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.
Experiment 4 - normal hearing (sham) - SAT
SHAM COMPARATORThe 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.
Experiment 4 - hearing impaired (tACS) - SAT
EXPERIMENTALThe 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.
Experiment 4 - hearing impaired (sham) - SAT
SHAM COMPARATORThe 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.
Experiment 4 - tinnitus (tACS) - SAT
EXPERIMENTALThe 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.
Experiment 4 - tinnitus (sham) - SAT
SHAM COMPARATORThe 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.
Experiment 5 - normal hearing (NF right) - AAT
EXPERIMENTALEach 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.
Experiment 5 - normal hearing (NF left) - AAT
ACTIVE COMPARATOREach 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.
Interventions
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.
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.
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
You may qualify if:
- Age: 18-35 / 55-75
- German as first language
- Normal or corrected to normal vision
- Right-handed
- Normal hearing: ≤20 decibel (dB) hearing level (HL) at frequencies from 250 Hz to 8,000 Hz for both ears.
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- University of Luebeckcollaborator
Study Sites (1)
University of Zurich
Zurich, 8090, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Basil Preisig, Dr.
University of Zurich
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- single-blind
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2022
First Posted
August 24, 2022
Study Start
November 1, 2023
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
December 7, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- after the project is completed
- Access Criteria
- upon personal request
The investigators intend to share the raw data of the included participants and the analysis code.