Req_4180740 SOW.docx

Statement of Work

A. Background Information This contract will support scanning and brain functional imaging studies of eight (8) subjects under NIH Clinical Protocol 97-DC-0057, Genetic studies of stuttering. This work will be done to support a collaborative study of brain structural and functional differences associated with stuttering. Previous studies of a large family with many cases of stuttering have identified a specific cause of stuttering in this family (Raza et al. Am J Hum Genet 97:715-725 (2015)). Preliminary brain imaging studies of the affected members of this family have generated promising results showing potentially abnormal features in brain structure and function in the individuals who carry the causative mutation. To complete this study, scans must be done using carefully matched normal individuals to demonstrate the differences found in stuttering subjects are not found in the normal population.

B. Purpose and Objectives The purpose of this contract is to bring Ho Ming Chow, PhD, to the NIH to perform brain imaging and data analysis. Dr. Chow was formerly a postdoctoral fellow in the Language Section of the NIDCD, and was the investigator who performed the preliminary brain scanning studies in the stuttering family described above. Dr. Chow has now assumed a position at the University of Michigan in Ann Arbor, MI. To render this study valid, the experimental methods used for the imaging studies described above must be exactly duplicated. The only way to insure this is to perform the studies with the same investigator, using the same instrumentation and the same analytical methods in the same setting within the NIH Clinical Center. This can only be practically achieved by bringing Dr. Chow to the NIH. The overall objective of this contract is to obtain data that will support discovery and publication of new findings regarding alterations in brain structure and function associated with specific, well-defined inherited deficits that cause stuttering.

C. Contractor requirements The contractor will be responsible for scanning subjects and analyzing the resulting data using the same instrumentation and analysis methods previously used in our studies of a large stuttering family described above. These methods will include:

Gathering imaging data Image quality checking White matter diffusivity measures White matter tractography measures Cortical thickness and volume measures Seed-based functional connectivity analyses Functional activation measures during speaking

The contractor will also be responsible for communicating results to other study team members, including written reports where appropriate, and will be responsible for producing written components of publications describing the study results. This includes background, materials and methods, results, and discussion.

Brain scanning of subjects will be performed during two visits to the NIH (4 days each) during the first half of calendar 2016, scheduled for the convenience of both the contractor and the human subjects being studied. Analysis of data and written communication of results will be provided within 3 months of completion of the last subject scan at the NIH.

D. Government Responsibilities This work will be performed at the NIH Clinical Center (CC) in Bethesda, MD using subjects enrolled at the NIH. NIH will provide resources for patient recruitment (including advertisement, outreach, and informed consent of subjects), clinical activities (including admitting, history and physical, scanning and brain imaging in the NIH CC, and medical records) and data analysis (including computer analysis hardware and software).

E. Reporting requirements and deliverables The contractor will keep the principal investigator continuously informed of the progress of the work by either in-person discussions or e-mail throughout the course of the contract, with a minimum frequency of once per week. The deliverables of the contract will consist of:

Brain imaging data from 8 normal subjects Analysis reports, including statistical analyses, for each of the contractor requirements above, in text and/or graphical format as appropriate Text, figures, figure legends, and references for publication of study findings Consulting on paper submission and response to reviews

F. Program management and control requirements Contractor will be paid upon invoice, to be approved by the principal investigator Partial invoices may be submitted following scanning of subjects and upon delivery of data to the project officer.

G. Inspection and acceptance criteria Potential contractors will be evaluated on the basis of experience within the National Institutes of Health/NINDS Clinical Center imaging facility and experience performing brain imaging studies of individuals with non-syndromic speech disorders. Work will be evaluated based on consistency with the methods and protocols previously used in brain imaging studies at the NIH Clinical Center and the NIDCD, and acceptability of data to both the project officer and to other members of the study team, including Allen Braun, MD, NIDCD.

H. Evaluation criteria Candidate contractors will be evaluated on both technical criteria and experience.

For technical criteria, the contractor will have strong expertise in human neuroimaging studies of speech and stuttering performed at the NIH Clinical Center (CC). Specific expertise will include knowledge of NIH subject recruitment and subject enrollment into NIH intramural research protocols, including expertise on NIH informed consent procedures, knowledge of admission and other clinical administrative requirements and procedures at the NIH CC, working knowledge of the scanning instruments and equipment at the NIH CC, and knowledge of the analytical methods previously used in the Section on Systems Biology of Communication Disorders and the Section on Neuroimaging of the NIDCD.

Experience must include working with NIH CC instruments, equipment, and clinical procedures, and specific experience with the following neuroimaging techniques performed on subjects undergoing evaluations of speech and language: White matter diffusivity measures, white matter tractography measures, cortical thickness and volume measures, seed-based functional connectivity analyses, and functional activation measures during speaking.

Price Among those technically acceptable offerors that have acceptable past performance, the offeror with the lowest price will receive the award.

Performance dates Phase I performance period is July 15, 2016 - May, 2017,