Trial Outcomes & Findings for Pediatric Image-Guided Cochlear Implant Programming (NCT NCT03886168)
NCT ID: NCT03886168
Last Updated: 2026-08-24
Results Overview
The spectral modulation detection (SMD) task of spectral resolution will use a 3-interval, 2-alternative forced-choice procedure. The participant will discriminate between flat-spectrum and spectrally-modulated noise presented at 65 dB SPL. The investigators will use a broadband stimulus and assess spectral modulation rates of 0.5 and 1.0 cycle per octave. Threshold will be expressed in modulation depth (in dB) for each modulation rate tested.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Data were gathered at baseline (Time 1), 12 months (Time 2) and 24 months (Time 3).
Results posted on
2026-08-24
Participant Flow
Participants were recruited from the audiology clinic at Vanderbilt University Medical Center. Enrollment began on 06/30/2019 and was completed 11/30/2022. Visits were at the Vanderbilt University Medical Center in the audiology lab (Gifford lab) for hearing assessments and the developmental disabilities lab (Camarata lab) for the speech, language and literacy assessments.
Participant milestones
| Measure |
Immediate IGCIP
Immediate signal processing intervention of a biomedical device
Signal processing intervention of a biomedical device: This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based on image processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.
|
Deferred IGCIP
Delayed signal processing intervention of a biomedical device.
Signal processing intervention of a biomedical device: This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based on image processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.
IGCIP was completed one year after enrollment for the deferred group.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
|
Overall Study
COMPLETED
|
24
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pediatric Image-Guided Cochlear Implant Programming
Baseline characteristics by cohort
| Measure |
Immediate IGCIP
n=24 Participants
Immediate signal processing intervention of a biomedical device
Signal processing intervention of a biomedical device: This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based on image processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.
|
Deferred IGCIP
n=23 Participants
Delayed signal processing intervention of a biomedical device.
Signal processing intervention of a biomedical device: This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based on image processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.
IGCIP was completed one year after enrollment for the deferred group.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
13 Participants
n=1541 Participants
|
12 Participants
n=1121 Participants
|
25 Participants
n=2662 Participants
|
|
Age, Categorical
<=18 years
|
24 Participants
n=1541 Participants
|
23 Participants
n=1121 Participants
|
47 Participants
n=2662 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Age, Continuous
|
7 years
n=1541 Participants
|
8 years
n=1121 Participants
|
7 years
n=2662 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=1541 Participants
|
11 Participants
n=1121 Participants
|
22 Participants
n=2662 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=1541 Participants
|
23 Participants
n=1121 Participants
|
46 Participants
n=2662 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
1 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=1541 Participants
|
2 Participants
n=1121 Participants
|
4 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
1 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=1541 Participants
|
21 Participants
n=1121 Participants
|
41 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
1 Participants
n=2662 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=1541 Participants
|
23 participants
n=1121 Participants
|
47 participants
n=2662 Participants
|
PRIMARY outcome
Timeframe: Data were gathered at baseline (Time 1), 12 months (Time 2) and 24 months (Time 3).Population: Children with severe hearing loss who have received a cochlear implant.
The spectral modulation detection (SMD) task of spectral resolution will use a 3-interval, 2-alternative forced-choice procedure. The participant will discriminate between flat-spectrum and spectrally-modulated noise presented at 65 dB SPL. The investigators will use a broadband stimulus and assess spectral modulation rates of 0.5 and 1.0 cycle per octave. Threshold will be expressed in modulation depth (in dB) for each modulation rate tested.
Outcome measures
| Measure |
Immediate IGCIP
n=24 Participants
Immediate signal processing intervention of a biomedical device
Signal processing intervention of a biomedical device: This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based on image processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.
|
Deferred IGCIP
n=23 Participants
Delayed signal processing intervention of a biomedical device.
Signal processing intervention of a biomedical device: This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based onimage processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.
IGCIP was completed one year after enrollment for the deferred group.
|
|---|---|---|
|
Spectral Resolution (Spectral Modulation Detection or SMD)
Baseline
|
14.06 SMD 0.5 cyc/oct (dB)
Interval 10.91 to 17.2
|
15.52 SMD 0.5 cyc/oct (dB)
Interval 12.49 to 18.6
|
|
Spectral Resolution (Spectral Modulation Detection or SMD)
12-Month
|
9.81 SMD 0.5 cyc/oct (dB)
Interval 6.66 to 13.0
|
9.70 SMD 0.5 cyc/oct (dB)
Interval 6.69 to 12.7
|
|
Spectral Resolution (Spectral Modulation Detection or SMD)
24-Month
|
8.79 SMD 0.5 cyc/oct (dB)
Interval 5.68 to 11.9
|
8.84 SMD 0.5 cyc/oct (dB)
Interval 5.79 to 11.9
|
SECONDARY outcome
Timeframe: Data were gathered at baseline (Time 1), 12 months (Time 2) and 24 months (Time 3).Population: Children with hearing loss who have received cochlear implants
The temporal resolution task includes sinusoidal amplitude modulation (SAM) detection with a 3-interval, 2-alternative forced-choice procedure.The participant will discriminate between noises with a flat temporal envelope and sinusoidal amplitude modulation. The investigators will use a broadband stimulus at 65 dB SPL and assess amplitude modulation rates of 4, 32, and 128 Hz. SAM threshold will be expressed in 20 log m (in dB), with m representing the modulation index (0 to 1).
Outcome measures
| Measure |
Immediate IGCIP
n=24 Participants
Immediate signal processing intervention of a biomedical device
Signal processing intervention of a biomedical device: This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based on image processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.
|
Deferred IGCIP
n=23 Participants
Delayed signal processing intervention of a biomedical device.
Signal processing intervention of a biomedical device: This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based onimage processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.
IGCIP was completed one year after enrollment for the deferred group.
|
|---|---|---|
|
Temporal Resolution (Sinusoidal Amplitude Modulation (SAM) Detection
Baseline
|
-6.41 4-Hz SAM (dB)
Interval -8.27 to -4.55
|
-6.47 4-Hz SAM (dB)
Interval -8.23 to -4.71
|
|
Temporal Resolution (Sinusoidal Amplitude Modulation (SAM) Detection
12-Month
|
-10.32 4-Hz SAM (dB)
Interval -12.18 to -8.46
|
-10.04 4-Hz SAM (dB)
Interval -11.82 to -8.26
|
|
Temporal Resolution (Sinusoidal Amplitude Modulation (SAM) Detection
24-Month
|
-10.89 4-Hz SAM (dB)
Interval -12.73 to -9.06
|
-11.29 4-Hz SAM (dB)
Interval -13.09 to -9.49
|
Adverse Events
Immediate IGCIP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Deferred IGCIP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immediate IGCIP
n=24 participants at risk
Immediate signal processing intervention of a biomedical device
Signal processing intervention of a biomedical device: This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based on image processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.
|
Deferred IGCIP
n=23 participants at risk
Delayed signal processing intervention of a biomedical device
Signal processing intervention of a biomedical device: This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based on image processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.
|
|---|---|---|
|
Ear and labyrinth disorders
Adverse Events
|
0.00%
0/24 • 2 years
Non-Systematic Assessment: A non-systematic method was employed for determining whether or not adverse events have occurred. This included self-reporting by participants or their parent or guardian and during annual assessment/testing sessions.
|
0.00%
0/23 • 2 years
Non-Systematic Assessment: A non-systematic method was employed for determining whether or not adverse events have occurred. This included self-reporting by participants or their parent or guardian and during annual assessment/testing sessions.
|
Other adverse events
Adverse event data not reported
Additional Information
Professor Stephen Camarata Principal Investigator
Vanderbilt University Medical Center
Phone: 615-579-5608
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place