Trial record 3 of 287501 for:
ALL
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
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| ClinicalTrials.gov Identifier: NCT03713554 |
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Recruitment Status :
Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
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Sponsor:
University of Michigan
Information provided by (Responsible Party):
Gregory Basura, University of Michigan
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Hearing Loss | Procedure: FNIRS Observational |
Show Detailed Description
| Study Type : | Observational |
| Estimated Enrollment : | 75 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| 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, 2018 |
| Estimated Primary Completion Date : | August 1, 2020 |
| Estimated Study Completion Date : | August 1, 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Nonsyndromic hearing loss
Intervention Details:
- 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.
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
SSD Patients
Criteria
Inclusion Criteria:
- Adults over age 18
Exclusion Criteria:
- prior otologic surgery
- any SSD less than profound hearing loss
- any subjected treated at an outside institution
Information from the National Library of Medicine
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
Contacts
| Contact: Gregory Basura, M.D., Ph.D. | 734-936-8006 | gbasura@umich.edu |
Sponsors and Collaborators
University of Michigan
| Responsible Party: | Gregory Basura, Otorhinolaryngology Department - Faculty and Staff Medical School - Faculty and Staff, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT03713554 History of Changes |
| Other Study ID Numbers: |
HUM00137093 |
| First Posted: | October 19, 2018 Key Record Dates |
| Last Update Posted: | October 19, 2018 |
| Last Verified: | October 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Gregory Basura, University of Michigan:
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SSD, unilateral hearing loss |
Additional relevant MeSH terms:
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Hearing Loss Deafness Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |