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

NCT03713554 | Withdrawn DMC

• 1 other identifier: HUM00137093
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The timing of brain changes that may influence hearing rehabilitation within human A1 after single-sided deafness (SSD) is not known. The goal is to determine when A1 neural plasticity occurs following SSD onset.

Conditions

Hearing Loss

Keywords

SSD, unilateral hearing loss

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  12 months

Secondary Outcomes (3)

• 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).

  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).

• 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)

  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).

• Cochlear implant (CI) speech performance

  Cochlear implant speech performance will be measured 6 and 12 months after implantation (Aim 3).

Interventions

FNIRS Observational PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

SSD Patients

You may qualify if:

• Adults over age 18

You may not qualify if:

• prior otologic surgery
• any SSD less than profound hearing loss
• any subjected treated at an outside institution

Sponsors & Collaborators

• University of Michigan: lead

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Unilateral

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Otorhinolaryngology Department - Faculty and Staff Medical School - Faculty and Staff

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 19, 2018
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After scientific papers are accepted for publication, data will be available for 7 years after study completion.
• Access Criteria: Researchers requesting data will first have to sign a data sharing agreement, agreeing to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, electronically securing the data while in use, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, no use of the data for commercial purposes and proper acknowledgement of the data resource.