Use of Functional Near-infrared Spectroscopy to Investigate Role of Human Auditory Cortex Plasticity and Multi-sensory Integration on Cochlear Implant Performance After Single-sided Deafness
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03713554|
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment|
|Hearing Loss||Procedure: FNIRS Observational|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||Use of Functional Near-infrared Spectroscopy to Investigate Role of Human Auditory Cortex Plasticity and Multi-sensory Integration on Cochlear Implant Performance After Single-sided Deafness|
|Estimated Study Start Date :||November 15, 2019|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
- Procedure: FNIRS Observational
In addition to completing an Informed Consent and survey questions, fNIRS Imaging and Electroencephalography (EEG) will take place will take place:The fNIRS imaging is experimental technology that has not been approved by the FDA. EEG is a noninvasive way to record electrical activity of the brain. The recording device is made up of electrodes that are fixed to a snug-fitting elastic cap. An MRI and EEG will follow the fNIRS procedure. The MRI will be performed before participants undergo fNIRS or EEG. The MRI will be done to show there are no lesions in the inner ear and therefore is a recruitment clearance tool.
- Change in Hemodynamic activity (fNIRS correlate of neural activity) in primary auditory cortex (A1) other non-auditory (somatosensory and visual) after single sided deafness; before and after cochlear implantation (CI). [ Time Frame: 12 months ]Functional near-infrared spectroscopy (fNIRS) is a non-invasive tool for measuring cortical hemodynamic activity in human auditory and non-auditory studies. fNIRS measures changing optical properties of the brain using infrared (IR) light to extrapolate and quantify hemodynamic responses through neurovascular coupling. When a specific brain region is activated, fNIRS measures changes in local hemoglobin as an index/correlate of neural activity within a chosen brain region.
- Resting state functional connectivity (RSFC; connectivity) between primary auditory cortex (A1) and other non-auditory (somatosensory and visual) cortices after single sided deafness; before and after cochlear implantation (CI). [ Time Frame: All fNIRS recordings will be taken at baseline (Aim 1) 1,3,6,9 and 12 months after single-sided deafness and at the same intervals after CI (Aim 2). ]Resting state functional connectivity (RSFC) is the association of baseline activity between two brain regions. Although RSFC portends anatomical/structural interactions it does not assess activity at the individual neuron level. By assessing RSFC, we obtain information regarding spatiotemporal patterns of hemodynamic cortical responses across brain regions, which are thought to reflect plastic changes that play a role in both adaptive and maladaptive conditions. RSFC has been proposed to represent contextual influences of connections involved in local processing, connections between regions that are likely to work together in the future, or serve to coordinate neural activity.
- Event-related potentials (ERPs from EEG recordings) in auditory cortex (A1) and other non-auditory (somatosensory and visual) cortices after single sided deafness; before and after cochlear implantation (CI) [ Time Frame: All EEG recordings will be taken at baseline (Aim 1) 1,3,6,9 and 12 months after single-sided deafness and at the same intervals after CI (Aim 2). ]Electroencephalography (EEG) is another non-invasive method used to capture neuro-electric activity. Scalp electrodes measure currents that flow during excitation of cortical pyramidal neurons. EEG measures event-related potentials (ERPs) that are fluctuations time-locked to an event or stimulus onset. Many investigative approaches combine fNIRS for spatial resolution and EEG for temporal resolution as each is linked to the same neuronal activities and therefore complementary.
- Cochlear implant (CI) speech performance [ Time Frame: Cochlear implant speech performance will be measured 6 and 12 months after implantation (Aim 3). ]All CI participants will undergo formal speech recognition testing per the clinical standard of care. Measures commonly used in clinical care of participants with CIs will be used in this study. Consonant-Nucleus-Consonant (CNC) monosyllabic words will be presented at a level of 60dB sound pressure level (SPL) in quiet. Additionally, two lists of sentences from the Bamford-Kowal-Bench Speech-in-Noise-Test (BKB-SIN) will be administered according to recommendations of the Minimal Speech Test Battery and will determine the SNR at which participants understand 50% of the words in the sentences.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713554
|Contact: Gregory Basura, M.D., Ph.D.||email@example.com|