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SUMMARY STATEMENT 

PROGRAM CONTACT: ( Privileged Communication ) Release Date: 10/26/2018 

Revised Date: 

Application Number: 1 R01 DC017683-01A1 

Principal Investigators (Listed Alphabetically): 

CAMARATA, STEPHEN MARK 

GIFFORD, RENE H (Contact) 

Applicant Organization: VANDERBILT UNIVERSITY MEDICAL CENTER 

Review Group: LCOM 

Language and Communication Study Section 

Meeting Date: 10/18/2018 RFAIPA: PA18-334 

Council: JAN 2019 PCC: HROS 

Requested Start: 04/01 /2019 

Project Title: Image-Guided Cochlear Implant Programming: Pediatric Speech, Language, and 

Literacy 

SRG Action: Impact Score:10 Percentile:1 

Next Steps: Visit https://grants.nih.gov/grants/next_steps.htm 

Human Subjects: 30-Human subjects involved - Certified, no SRG concerns 

Animal Subjects: 10-No live vertebrate animals involved for competing appl. 

Gender: 1A-Both genders, scientifically acceptable 

Minority: 1A-Minorities and non-minorities, scientifically acceptable 

Children: 2A-Only Children, scientifically acceptable 

Project Estimated 

Year Total Cost 

1 

2 

3 

4 

5 

TOTAL 

ADMINISTRATIVE BUDGET NOTE: The budget shown is the requested budget and has not been adjusted 

to reflect any recommendations made by reviewers. If an award is planned, the costs will be calculated by 

Institute grants management staff based on the recommendations outlined below in the COMMITTEE 

BUDGET RECOMMENDATIONS section. 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1 R01 DC017683-01A1 2 LCOM 

GIFFORD, R 

1R01DC017683-01A1 Gifford, Rene 

RESUME AND SUMMARY OF DISCUSSION: This resubmitted application proposes a project to 

investigate the effects of individualized, image-guided cochlear-implant programming (IGCIP) on 

auditory processing and language outcomes in children ages 6- to 12-years-old. This project addresses 

a critical need for improvement in outcomes for children with cochlear implants (CI), and if successful, 

this project would have both clinical and theoretical impact. The premise is well-supported by prior 

work. The investigative team is outstanding, with excellent expertise for the project, and the 

environment is also strong. The application is highly responsive to prior review. The approach is 

rigorous and well-designed, using a variety of close and distal outcome measures, and has a detailed 

and feasible timeline. The panel noted only minor weaknesses, including that the project is not highly 

innovative, but panel members agreed that the level of innovation is appropriate for this project. 

Additional concern was raised that the length of testing may pose challenges for data collection from 

this age group. These weaknesses do not detract from the likelihood that this outstanding project will 

exert a large, sustained impact in a significant and much-needed area of research. 

DESCRIPTION (provided by applicant): Although the recent literature has indicated that children 

receiving cochlear implants (CIs) often have dramatically improved speech and language ability relative 

to previous generations of children with hearing loss, many pediatric CI recipients display persistent 

speech and language disorders despite early implantation and associated speech/language 

intervention. There is a striking paucity and ongoing need for studies that systematically examine the 

relationship between intracochlear electrode location, audiological profile, and subsequent phonological 

awareness, speech, language, and literacy in pediatric CI recipients. This project provides a unique 

opportunity to examine whether individualized, image-guided CI programming (IGCIP) significantly 

improves outcomes in pediatric CI patients. The proposed research activities will examine the impact of 

personalized IGCIP in pediatric CI recipients on measures of basic auditory function (spectral, 

temporal, and spectrotemporal resolution), word and non-word recognition, speech production, 

language, phonological awareness, and reading comprehension using a double blind, waitlist control 

randomized clinical trial (RCT) design. A total sample of 72 children with CIs aged six to twelve years 

old will be enrolled in the project: half (n = 36) will be randomized to an immediate IGCIP condition and 

half to a waitlist control condition. The waitlisted participants (n = 36) will undergo IGCIP after 12 

months of monitoring and then followed for an additional 12 months after intervention (total time in the 

study for both groups: 24 months). Those immediately provided with IGCIP will also be followed for a 

total of 24 months. All participants will undergo extensive audiological assessment as well as tests of 

phonological awareness, speech, language, and literacy at baseline as well as at regular intervals: 2, 6, 

12, 14, 18, and 24 months. We will use predictor analyses to determine the impact of immediate and 

deferred IGCIP on subsequent auditory, speech, language, and literacy outcomes. 

PUBLIC HEALTH RELEVANCE: Despite significant advancements in technology and outcomes, 

pediatric cochlear implant (CI) recipients display persistent delay on measures of speech, language, 

and literacy despite early implantation and extensive speech/language intervention. Most CI recipients 

are programmed using a one-size-fits-all approach to setting upper and lower stimulation levels, 

maximum number of active electrical contacts, and selection of various signal processing parameters 

for electrical stimulation of the auditory system. Our interdisciplinary research team will examine the 

impact of a personalized, image-guided approach to CI programming and its effect on auditory 

processing, speech recognition, speech production, phonological processing, language, and literacy. 

CRITIQUE 1 

Significance: 1 

Investigator(s): 1 

Innovation: 3 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1 R01 DC017683-01A1 3 LCOM 

GIFFORD, R 

Approach: 2 

Environment: 1 

Overall Impact: This application seeks to teach a new cochlear implant programming strategy against 

the current standard of care programming strategy for 6- to 12-year-old children. Children are 

monitored for 1 to 2 years following programming on a variety of measures of working memory, auditory 

processing, speech, language, and pre-literacy skills to examine differences in closely related (auditory 

processing) and less closely related skills (speech, language, preliteracy). The scientific design is 

strong with an appropriate double blind randomization design, a well-specified and likely sensitive 

outcome measures, and an appropriately powered and detailed statistical analysis plan. The 

investigators and consultants have deep expertise in all aspects of the research and the environment is 

well suited to the type of research and the selected patient population. Although there are very minor 

weaknesses in innovation and in the preliminary data, these do not detract from the likely impact of the 

research. The proposed research is well suited to determining whether the new programming strategy 

has benefits over the standard programming strategy and will provide clear direction in whether and 

how the development of this new programming strategy should proceed. 

1. Significance: 

Strengths 

 There is tremendous variability in the outcomes of cochlear implantation. This application seeks 

to improve functioning of CIs by using a more individualized fitting strategy based on the actual 

location of the CI in the cochlea. 

 The proposed research examines differences between programming strategies (current 

standard of care versus the new Image-Guided Cochlear Implant Programming - IGCIP) on 

auditory functioning and then subsequent differences in speech, language, and pre-literacy 

skills over a 1- to 2-year period. As such, the research evaluates the impact of the different 

programming strategies on near and distal outcomes. 

 In addition to evaluating the different programming strategies, the longitudinal nature of the 

design combined with analysis of complex relationships among skills (e.g., mediated 

relationships between auditory processing and speech/language/pre-literacy skills) has strong 

potential to inform our understanding of how development in these areas influence each other. 

 The scientific premise is strong and preliminary data demonstrates the potential promise of the 

new programming strategy. 

Weaknesses 

 No major weaknesses noted. 

2. Investigator(s): 

Strengths 

 The local team is excellent with well-established and well-qualified scientists in all significant 

topic areas: CI, auditory function, speech perception (Gifford); child speech and language 

(Camarata), surgical/bioengineering (Labadie, Noble, Dawant), and biostatistics (Dietrich). 

 The expertise of the local team is further bolstered by external consultants who add expertise in 

speech perception, phonological awareness, and reading (Nittrouer, Bunta) 

 The local team has been collaborating on the development of the new programming strategy 

across several grants and publications, demonstrating the ability to work effectively together and 

to run large scale collaborative projects. 
 

 

 

 

 

 

 

 

 

1 R01 DC017683-01A1 4 LCOM 

GIFFORD, R 

Weaknesses 

 No major weaknesses noted. 

3. Innovation: 

Strengths 

 The proposed research is among the first to test this new programming strategy with children 

 This study is among the first to examine such a wide array of skills with sufficient power to 

unpack subtle relationships (e.g., mediation) among these skills. 

Weaknesses 

 Other aspects of the design are fairly standard (e.g., standardized tests, research protocols). 

This increases feasibility and confidence that the measures will be sensitive to the outcomes but 

somewhat limits innovation. 

4. Approach: 

Strengths 

 The overall design (double blind randomized immediate treatment vs. waitlist control) is a strong 

design for addressing the aims 

 The outcome measures have been carefully chosen based on past research. There is evidence 

that the measures will be sensitive to differences between treatment and control conditions as 

well as change over time. 

 The statistical analysis plan is well specified including how common challenges (e.g., missing 

data, intention to treat, baseline differences) will be addressed. 

 Sample size was determined using a power analysis and included appropriate attention to likely 

attrition. 

 Initial outcomes are appropriately assessed 1-month post treatment to allow families to opt out 

of the treatment if it is detrimental. This is an ethically appropriate way to allow families to 

choose whether to continue in the trial or not once the treatment has been applied. 

 The timeline is specified in detail and appears to be feasible. 

Weaknesses 

 Preliminary data suggest the potential benefits of the new mapping strategy but effects are 

somewhat modest and potentially variable. This is only a minor concern because the proposed 

clinical trial is appropriately powered to test for the effect sizes observed in the preliminary data 

and also appropriately powered to explore individual differences as a means of informing further 

development of this treatment. 

5. Environment: 

Strengths 

 Infrastructure for clinical research and recruitment of participants is excellent. Environment is 

highly conducive to accomplishing the aims in the planned timeline. 

Weaknesses 

 No major weaknesses noted. 
 

 

 

 

1 R01 DC017683-01A1 5 LCOM 

GIFFORD, R 

Study Timeline: 

Strengths 

 Timeline contains ample detail. Timeline is feasible. 

Weaknesses 

 No major weaknesses noted. 

Protections for Human Subjects: 

Acceptable Risks and/or Adequate Protections 

 Risks are minimal with appropriate safeguards and consent procedures 

Data and Safety Monitoring Plan (Applicable for Clinical Trials Only): 

Acceptable 

 The local IRB has indicated that a data safety monitoring board is not needed given the low risk 

of the research. 

Inclusion of Women, Minorities and Children: 

 Sex/Gender: Distribution justified scientifically 

 Race/Ethnicity: Distribution justified scientifically 

 For NIH-Defined Phase III trials, Plans for valid design and analysis: Not applicable 

 Inclusion/Exclusion of Children under 18: Including ages <18; justified scientifically 

 Demographics of the participants are expected to match the Vanderbilt CI patient 

characteristics. 

Vertebrate Animals: 

Not Applicable (No Vertebrate Animals) 

Biohazards: 

Not Applicable (No Biohazards) 

Resubmission: 

 Investigators were highly responsive to prior critiques. 

Authentication of Key Biological and/or Chemical Resources: 

Not Applicable (No Relevant Resources) 

Budget and Period of Support: 

Recommend as Requested 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1 R01 DC017683-01A1 6 LCOM 

GIFFORD, R 

CRITIQUE 2 

Significance: 1 

Investigator(s): 1 

Innovation: 1 

Approach: 3 

Environment: 1 

Overall Impact: This proposal aims to evaluate the impact of a personalized, image-guided approach 

to CI programming and its effect on the development of speech and language measures as well as on 

phonological processing and reading skills. Using a double-blinded randomized waitlist control trial with 

a longitudinal monitoring component, the efficacy of an innovative image-guided CI mapping method 

will be evaluated. Overall, the study has the potential to change the current standard of care for children 

with CIs by providing customized CI mapping to improve speech and language outcomes. It will also 

provide a rich data matrix that will inform theoretical models of speech language development in CI 

users. The approach is well designed and all outcome variables are justified and the environment at 

Vanderbilt Medical Center is excellent for conducting this study. The team is outstanding and the 

proposed timeline is justified and feasible. However, a few critique points remain, mostly related to the 

approach. The proposed age range is not adequately justified. The youngest participants will be 6 years 

which means that it is likely that they already received 1-2 years of formal reading instruction with 

suboptimal CI programming which may already resulted in poor pre-literacy and reading outcomes as 

well as a negative attitude towards reading which may be prevented with a younger start age. 

Furthermore, environmental variables that have been shown to influence reading outcome in typical 

developing children are not considered and reading fluency has been ignored as a potential construct 

but it could play an important role in the relationship between phonological processing, oral listening 

comprehension and reading comprehension. 

1. Significance: 

Strengths 

 Children with CI show profound deficits in language processing even if the CI was implanted 

early. Examining lower level auditory function and speech recognition skills and their 

relationship to the development of speech, language, phonological awareness and reading skills 

is of high significance. 

 The current clinical ‘one-fits-all’ approach to CI programming is often suboptimal and the 

proposed study testes the efficacy of the novel ICGP approach which employs a personalized, 

customized approach to mapping 

 The proposed study will have strong implications for clinical care and will add to theoretical 

foundations 

Weaknesses 

 The construct of reading fluency is absent in the theoretical foundation of this proposal but may 

explain variance in reading comprehension. 

2. Investigator(s): 

Strengths 

 The investigative team and consultants are very well suited to address the project’s aims. The 

team members have a history of collaborations in adults with CI. 
 

 

 

 

 

 

1 R01 DC017683-01A1 7 LCOM 

GIFFORD, R 

 The team has the expertise to manage a project of this scope and has experience with clinical 

trials. 

Weaknesses 

 No major weaknesses noted. 

3. Innovation: 

Strengths 

 The development of ‘expected’ longitudinal growth trajectories for speech and language 

development in pediatric CI users is highly innovative and has the potential to impact clinical 

care and assessments. 

 The application of image-guided CI mapping in children in order to develop personalized CI 

mapping is innovative and has the potential to replace current clinical care models. 

 The investigation of auditory function and speech perception as well as phonological awareness 

measures and reading skills and their interactions will provide a rich data matrix. 

Weaknesses 

 No major weaknesses noted 

4. Approach: 

Strengths 

 The study is well designed and all aspects of the analysis plan are well specified. The use of 

waitlist control and a longitudinal timeline is important for examining the aims of this proposal. 

 The preliminary studies show promising results in pediatric populations but this RCT is needed 

to further characterize effects, especially on reading skills. 

 All outcome variables are well designed and justified. 

Weaknesses 

 Although the age range has been justified, the argumentation is weak. Standardized tests for 

phonological awareness and early reading are normed for children younger than 6 years. The 

proposal aims to investigate phonological awareness and its relationship to reading skills but the 

youngest children will be examined after the onset of formal reading instruction which may be 

too late to close the gap between CI users and controls. 

 Environmental variables that could potentially influence outcome measures, especially reading 

skills are not examined. This includes quality and type of instruction, quality of reading in the 

home, etc. 

5. Environment: 

Strengths 

 Vanderbilt University Medical Center is one of the largest CI programs in the US and the 

environment is well suited for this study. 

Weaknesses 

 No major weaknesses noted. 
 

 

 

1 R01 DC017683-01A1 8 LCOM 

GIFFORD, R 

Study Timeline: 

Strengths 

 The timeline is well designed and described in great detail 

Weaknesses 

 No major weaknesses noted. 

Protections for Human Subjects: 

Acceptable Risks and/or Adequate Protections 

Data and Safety Monitoring Plan (Applicable for Clinical Trials Only): 

Acceptable 

Inclusion of Women, Minorities and Children: 

 Sex/Gender: Distribution justified scientifically 

 Race/Ethnicity: Distribution justified scientifically 

 For NIH-Defined Phase III trials, Plans for valid design and analysis: Not applicable 

 Inclusion/Exclusion of Children under 18: Excluding ages <18; justified scientifically 

Vertebrate Animals: 

Not Applicable (No Vertebrate Animals) 

Biohazards: 

Not Applicable (No Biohazards) 

Resubmission: 

 The team has been very responsive to the previous critique and has addressed most challenges 

and barriers. 

Resource Sharing Plans: 

Acceptable 

Authentication of Key Biological and/or Chemical Resources: 

Not Applicable (No Relevant Resources) 

Budget and Period of Support: 

Recommend as Requested 

CRITIQUE 3 

Significance: 1 
 

 

 

 

 

 

 

 

1 R01 DC017683-01A1 9 LCOM 

GIFFORD, R 

Investigator(s): 1 

Innovation: 3 

Approach: 2 

Environment: 2 

Overall Impact: This is a highly significant, and well-specified proposal from a top team of researchers, 

with very few weaknesses. It was already a strong proposal on the previous review, and the changes 

made have enhanced the proposal. 

1. Significance: 

Strengths 

 Addressing the underlying causes for variability in CI outcomes is highly significant. 

 Many individuals do not appear to make the gains from their CI as might be expected; this 

proposal represents a potential way of addressing this. 

 Image-guided cochlear implant programming (IGCIP) has been shown to be beneficial in adult 

CI users, and thus testing it in pediatric users is a logical next step. 

 Understanding how spectral resolution relates to auditory skills, phonological skills, speech 

skills, and reading skills, allows for the development of better models of the process of skill 

development in this population. 

Weaknesses 

 Given that Nittrouer has shown that children place less weight on spectral cues than adults, why 

would a strategy that aids in spectral/spatial selectivity be advantageous? 

2. Investigator(s): 

Strengths 

 The team has a history of productive collaboration 

 PIs both have a strong publication and grant record. 

 Other members of the team have complementary strengths (speech perception, otology, 

imaging, biostatistics, phonological development, etc.), and generally have strong records. 

 The team are experts in image-guided cochlear implant programming (IGCIP). 

Weaknesses 

 No major weaknesses noted. 

3. Innovation: 

Strengths 

 Attempting to develop individualized programming techniques for pediatric CI users is 

innovative. 

Weaknesses 

 The tasks used are fairly standard, although this does help in interpreting them and relating 

them to the prior literature. 
 

 

 

 

1 R01 DC017683-01A1 10 LCOM 

GIFFORD, R 

4. Approach: 

Strengths 

 Approach includes a wide array of assessments. 

 Participant size is based on a power analyses 

 Detailed statistical plans are in place, as well as plans for addressing missing data, and plans 

for addressing a decrement in performance. 

 Timeline is reasonable and well-specified. 

Weaknesses 

 Given the large number of assessments, might attentional skills be a relevant factor in these 

children? 

 Children will have already been implanted for some time; given that, one concern is that families 

who opt to participate in this study will specifically be those who were not gaining as great of a 

benefit from their CI as was expected/desired; this could artificially inflate the overall benefits of 

IGCIP. 

 The data management plan stops midsentence on page 125; it is not clear how an aberrant 

change in performance in a child whose programming was not changed would be addressed. 

5. Environment: 

Strengths 

 Physical environment is adequate. 

 Access to software platforms that aid in collaboration and data management. 

 Vanderbilt’s CI surgical facilities and Hearing & Speech Sciences department are co-located, as 

are the labs, making collaboration easier. 

 VU Medical Center has a large number of CI implantees as patients; as PI is the director of the 

CI program, there is presumably no question about recruiting from there. 

Weaknesses 

 No discussion of intellectual environment. 

Study Timeline: 

Strengths 

 Well specified, with consideration of family/school schedules as well as timelines for completion. 

Weaknesses 

 No major weaknesses noted. 

Protections for Human Subjects: 

Acceptable Risks and/or Adequate Protections 

 Minimal risk study, with the potential for clinical gains. 

Data and Safety Monitoring Plan (Applicable for Clinical Trials Only): 

Acceptable 
 

 

 

 

 

1 R01 DC017683-01A1 11 LCOM 

GIFFORD, R 

Inclusion of Women, Minorities and Children: 

 Sex/Gender: Distribution justified scientifically 

 Race/Ethnicity: Distribution justified scientifically 

 For NIH-Defined Phase III trials, Plans for valid design and analysis: Not applicable 

 Inclusion/Exclusion of Children under 18: Including ages <18; justified scientifically 

 They note that the ethnic/racial distribution of CI users is unknown and may not reflect the 

broader community. 

Vertebrate Animals: 

Not Applicable (No Vertebrate Animals) 

Biohazards: 

Not Applicable (No Biohazards) 

Resubmission: 

 The previous version of this proposal was seen as highly significant, and the inclusion of both 

near and distal outcome measures were a strength - these aspects remain. 

 The approach had been seen as generally strong, but with a few particular weaknesses: the 

timeline was not clear, the experimenters were not blinded, there was no assessment of working 

memory, and the age range was not justified. All of these concerns have been addressed in the 

new submission. 

Authentication of Key Biological and/or Chemical Resources: 

Not Applicable (No Relevant Resources) 

Budget and Period of Support: 

Recommend as Requested 

THE FOLLOWING SECTIONS WERE PREPARED BY THE SCIENTIFIC REVIEW OFFICER TO 

SUMMARIZE THE OUTCOME OF DISCUSSIONS OF THE REVIEW COMMITTEE, OR REVIEWERS’ 

WRITTEN CRITIQUES, ON THE FOLLOWING ISSUES: 

PROTECTION OF HUMAN SUBJECTS: ACCEPTABLE 

It was noted during the meeting that the Data and Safety Monitoring Plan appears incomplete. 

INCLUSION OF WOMEN PLAN: ACCEPTABLE 

INCLUSION OF MINORITIES PLAN: ACCEPTABLE 

INCLUSION OF CHILDREN PLAN: ACCEPTABLE 

COMMITTEE BUDGET RECOMMENDATIONS: The budget was recommended as requested. 
 

 

 

1 R01 DC017683-01A1 12 LCOM 

GIFFORD, R 

Footnotes for 1 R01 DC017683-01A1; PI Name: Gifford, Rene H 

NIH has modified its policy regarding the receipt of resubmissions (amended applications). 

See Guide Notice NOT-OD-14-074 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD14-074.html. The impact/priority score is calculated after discussion of an application by 

averaging the overall scores (1-9) given by all voting reviewers on the committee and 

multiplying by 10. The criterion scores are submitted prior to the meeting by the individual 

reviewers assigned to an application, and are not discussed specifically at the review meeting 

or calculated into the overall impact score. Some applications also receive a percentile 

ranking. For details on the review process, see 

http://grants.nih.gov/grants/peer_review_process.htm#scoring. 
 

 

MEETING ROSTER 

Language and Communication Study Section 

Biobehavioral and Behavioral Processes Integrated Review Group 

CENTER FOR SCIENTIFIC REVIEW 

LCOM 

10/18/2018 - 10/19/2018 

Notice of NIH Policy to All Applicants: Meeting rosters are provided for information purposes only. Applicant 

investigators and institutional officials must not communicate directly with study section members about an 

application before or after the review. Failure to observe this policy will create a serious breach of integrity 

in the peer review process, and may lead to actions outlined in NOT-OD-14-073 at 

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-073.html and NOT-OD-15-106 at 

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-106.html, including removal of the application from 

immediate review. 

CHAIRPERSON(S) 

MEMBERS 
SCIENTIFIC REVIEW OFFICER 

EXTRAMURAL SUPPORT ASSISTANT 

• Temporary Member. For grant applications, temporary members 

may participate in the entire meeting or may review only selected 

applications as needed. 

Consultants are required to absent themselves from the room 

during the review of any application if their presence would 

constitute or appear to constitute a conflict of interest.