SOURCES SOUGHT
A -- Brain Computer Interfacefor Communication
- Notice Date
- 12/23/2008
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- National Institutes of HealthOD - Office of Logistics andAcquisition OperationsBethesdaMD20892-7511
- ZIP Code
- 20892-7511
- Solicitation Number
- NIHDC2009008
- Response Due
- 1/12/2009
- Archive Date
- 2/11/2009
- Point of Contact
- KUTA, LOUIS A 301 496 8024, kutal@mail.nih.gov<br />
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION This Sources Sought announcement is in support of market research being conducted by the National Institutes of Health (NIH) to identify small businesses such as 8(a), HUBZone, Small Disadvantaged Businesses (SDB), Women-Owned Small Businesses (WOSB), and Service-Disabled Veteran-Owned Small Business (SDVOSB), that are capable of performing the requirements identified in the description and Statement of Work (SOW) below. The intended procurement will be classified under NAICS code 541712. This is not a request for technical or cost proposals. No solicitation is available at this time and requests for solicitation packages will not receive a response. This Sources Sought Notice is for information and planning purposes only and is not to be construed as a commitment by the Government. No reimbursement will be made for any costs associated with providing information in response to this Synopsis. No collect telephone calls will be accepted. DESCRIPTION The National Institute on Deafness and Other Communication Disorders (NIDCD), NIH, is seeking small businesses that possess the ability to construct, implant, and perform subject tests with a Brain Computer Interface (BCI) able to acquire multiunit neural signals from 50 or more sites in the brain of subjects severely impaired in their ability to speak or otherwise communicate. Specialized devices, subject tests, and training procedures shall be developed to optimize use of this communication prosthesis in appropriate patient populations. STATEMENT OF WORK Background: NIDCD held a workshop in May, 2006, to evaluate brain-computer interfaces (BCI) which could be used to control speech synthesis software and other forms of assistive technology that support the communication needs of patients who are locked in. During these discussions of the existing technology and its potential use for this application, the workshop participants agreed that the merit of this approach had been proven through a number of animal studies and a limited number of tests with human subjects. Human studies with BCIs have already demonstrated the ability to control computer cursor movements over two dimensions, and these results have been translated into a means for human subjects to control movement of a robotic arm. Patient testing and signal analysis techniques already employed for these studies provide a solid foundation for development of a BCI. Two areas were identified for additional development. First, studies in human subjects are required to determine the appropriate placement of the recording electrodes for acquisition of neural activity that can be modulated to provide control signals appropriate for communication tasks. Specialized subject testing and training procedures are required for use when testing patients for this application. Second, specialized audiovisual output devices are likely to be required in order to optimize the subjects ability to communicate through a BCI, and additional development of signal extraction algorithms is likely to facilitate the acquisition of user control signals from a BCI. NIDCD is requesting proposals that focus on acquiring neural response data and assessment of BCI device capabilities through studies with human subjects. This initiative will support investigations of electrode placement in different regions of the brain and speech motor nerve pathways and development of subject testing techniques that are optimized for communication prostheses. Chronic studies in patients with brainstem stroke or amyotrophic lateral sclerosis (ALS) are of particular interest. Objective: The contractor shall construct and implant a research Brain Computer Interface (BCI) able to acquire signals based on neural activity and function as a communication prosthesis for subjects with severe impairments in their ability to speak or otherwise communicate. Specialized subject testing and training procedures shall be developed to optimize use of the prosthesis in appropriate patient populations. Work to be performed: A. Fabricate or obtain a surgically implantable device with multiple electrodes able to sense single and/or multiunit neural activity and convey this signal outside of the subjects body. 1.The electrode design shall allow for placement of at least 100 distinct recording sites and support signal acquisition from independent populations of neurons. 2.The signal from each electrode site shall be conveyed outside of the subjects body with a minimum of predefined signal processing, such as that provided by a percutaneous connector. 3.Since FDA approval for investigational use of this device in human studies will be required, electrodes and devices which already have this approval shall be used when possible. Enhancement of this component can be proposed over the course of the project. B. Fabricate or obtain components that can be placed outside the subject to amplify the signal recorded from each electrode site and convey this signal to outside processing components. 1.This device shall be constructed to ensure patient safety during BCI operation, regardless of any functions that might be performed by subsequent components of the signal processing chain. 2.The following data shall be recorded during subject tests for subsequent offline re-analysis: unprocessed signals acquired from each electrode, extracted neural activity, decoded signals believed to be under the subjects control, and the communication result intended by the subject. 3.Sharing of recorded data from some patient test sessions shall be made available to outside researchers; this activity will be coordinated with the NIDCD project officer. C. Fabricate or obtain hardware and software components which are able to detect neural activity in real time and decode subject-modulated signals. Substantial signal processing capabilities should be provided to support band pass filter operation, artifact removal, and neural spike discrimination so that single or multi-unit neural activity can be extracted and displayed in real time. D. Fabricate or obtain output components which provide both audio and visual representations that convey the test subjects intent for communication, based on inputs received from the signal processing components described in items B and C (above). E. All signal processing functions provided to accomplish items B, C, and D (above) shall be encapsulated within individual hardware devices used in the signal processing chain for subject tests but readily replaceable with hardware that performs a similar function through alternate algorithms. F. Develop a study protocol to acquire neural activity over a period of at least 12 months with the goal of using neural activity to operate the prosthesis and support communication. This will require identification of candidate human subjects with a reduced ability to communicate, such as patients with the locked-in syndrome that can result from brainstem stroke or advanced stages of ALS. G. Surgically implant the neural interface in at least one subject. Specific approval from the NIDCD project officer shall be obtained before implanting any human subjects. H. Perform tests of the brain-computer interface to assess its ability to support communication needs of the subject. These tests shall include both synthesized speech generation and other communication tasks. Subject training and experience effects shall be addressed to quantify effects on performance. Tests with at least one subject shall be underway by the end of contract year one (1). I. Create quantitative performance criteria and evaluate the ability of the overall system to function as intended. 1.Assess of the range of modulations in neural activity under subject control and the stability of this signal over an extended period of time. 2.Assess the ability of neural activity modulations to provide the required control signals. 3.Make specific recommendations on the merits and limitations for neural interface signal processing, signal detection, control algorithms, and the audiovisual output technologies. J. Based on the results from the above studies, recommend and implement appropriate modifications in the design and function of the prosthesis. Perform studies with additional human subjects after obtaining specific approval from the NIDCD Project Officer before implanting each subject. 1.A range of electrode placements in the neural tissue shall be assessed over the course of the project. 2.Tests with augmentative and alternative communication (AAC) strategies shall be included with the audiovisual output technologies evaluated. 3.Initial studies can be performed with stationary equipment in the laboratory environment, but proposals shall include plans for the use of portable devices by the end of contract year three (3). K. Publish research data in peer-reviewed scientific journals. Data acquired during performance of the project shall be fully analyzed to determine important trends and subsequently published in the peer-reviewed literature. At least one submission for peer-review in a scientific journal is required on an annual basis to provide a timely review of the ongoing research and wide dissemination of the results. Required Travel: The Contractor shall travel to a national scientific meeting on an annual basis to discuss and present recent findings of the studies performed under the contract in conjunction with other NIDCD Neural Prosthesis Development PIs. The semiannual Conference on Implantable Auditory Prosthesis and the annual meetings of the Association for Research in Otolaryngology are typically candidates for these meetings. Offerors should estimate two persons traveling for four days per year. Deliverables: In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit to the Government the following reports/deliverables in the manner and number specified below: A. Quarterly Progress Report The Quarterly Progress Report shall consist of an abstract summarizing activity followed by a brief description of the work performed during the previous quarter and the anticipated work plan for the coming quarter. The first reporting period consists of the first full quarter of performance, including any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months. The report shall be submitted within 15 calendar days of the end of each quarter of the contract. A Quarterly Report is not due for the final quarterly period of the contract. One copy of each Quarterly Progress Report shall be submitted in the PDF electronic document format to the Project Officer and to the Contracting Officer by e-mail; addresses will be provided at the time of the award. Proprietary information may be withheld, after approval by the Project Officer. B. Final Report The Final Report shall briefly summarize the findings of the studies performed under the contract and shall include both positive and negative results; it should also provide recommendations for future research and development in the area. Research results from the last quarter of the contract should be included. Articles published, or submitted for publication, during the contract period should be listed and reprints should be included as an appendix. One copy of the Final Report shall be submitted to the Project Officer and to the Contracting Officer by e-mail (addresses will be provided at the time of the award) in the PDF document format on or before the expiration date of the contract. The Final Report will be made available to the public through the NIDCD Neural Prosthesis Development Web page (www.nidcd.nih.gov/npp). Proprietary information may be withheld, after approval by the Project Officer. INSTRUCTIONS Interested small businesses are invited to submit a capability statement addressing their ability to satisfy the requirement. The capability statement shall reference Sources Sought Synopsis number NIHDC2009008 and shall be 12 point Arial font with no less than one inch margins, no greater than 25 pages in length and shall include the following: (1) name and address of the company; size standard and small business program status of the company as listed under www.ccr.gov; (2) point of contact with name, title, telephone number, facsimile number, and e-mail address; (3) DUNS number; (4) contractor's capability statement that demonstrates the firm's ability, knowledge, and experience specific to the requirements set forth in the draft statement of work (NOTE: this item shall be 1.5 spaced); (5) lists of three clients to whom similar types of services have been previously provided within the last three years to include contract number, dollar value, and name and telephone number of point of contact; and (6) qualifications and experience of any key personnel likely to perform directly under any resultant contract (NOTE: this item shall be 1.5 spaced). Respondents will not be notified of the results of the evaluation. Information received will be considered solely for the purpose of determining whether sufficient small businesses possess the experience, expertise, and qualifications to ensure competition under a set-aside acquisition. A determination by the Government not to compete this requirement as a set-aside based upon responses to this notice is solely within the discretion of the Government. Interested firms are to mail two (2) copies of their capability statement to the Primary Point of Contact at either address identified in these instructions as follows: Primary Point of Contact: Mr. Louis A. Kuta, Sr., Contract Specialist,Telephone: 301-496-8024, FAX: 301-402-0178, email: kutal@od.nih.gov. Courier Address:6100 Executive BoulevardSuite 6E01Rockville, MD 20852 U.S. Postal Service Address:6100 Executive BoulevardMSC 7540 Suite 6E01Bethesda, MD 20892-7540 Secondary Point of Contact: Ms. Silver C. Jones, Contracting Officer,Telephone: 301-496-8504, FAX: 301-402-0178, email: joness@od.nih.gov. Statements should be received no later than 4:00 PM EST, January 12, 2009. Late, faxed or emailed responses will not be accepted.
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