DOMAIN SPECIFIC TASKS OF EXECUTIVE FUNCTIONS RELEASE DATE: April 6, 2004 NOTICE: NOT-NS-04-012 National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) The National Institute of Neurological Disorders and Stroke (NINDS) is exploring the market interest and capabilities relating to the development of valid, reliable and domain specific tasks of Executive Functions for measurement and adequate intervention of executive dysfunction in neurological disorders. NINDS is attempting to identify competent sources to establish and coordinate the research activities leading to new measurement approaches. Background Executive Function (EF) refers to a constellation of cognitive abilities that include the ability to plan, organize, and sequence tasks and manage multiple tasks simultaneously. Appropriate EF also includes components of self- monitoring and self-correcting behaviors. These important behaviors are compromised in healthy elders and in people with neurological, mental and age related disorders, leading to disruption of lifestyle and loss of independence. One obstacle for progressive research in this area of cognition is a paucity of valid and reliable tasks that specifically tap domains of EF. While some research has been ongoing with funding from NIH, the National Science Foundation and the McDonnell Foundation, it has been difficult to establish standard operational definitions of Executive Functions, resolve areas of controversies such as the design and validation of comprehensive neuropsychological tests to assess multiple domains of Executive Function in both basic and clinical research settings. This solicitation will take advantage of the state of our knowledge on research issues such as: neural pathways associated with executive function; appropriate animal models to study executive function; the nature, extent and rate of change of executive function in pathological states; the characterization sparing or impairment - of executive function in neurodegenerative diseases; current tasks for assessment of executive function and the development of new tasks; factors that modulate executive function; and feasible behavioral and/or pharmacological interventions. The development of domain specific tasks of executive function as specified in this proposed solicitation will be of considerable value to many of NINDS current and future research programs in neurological disorders where dysfunction in cognitive processes are integral components of functional outcomes and quality of life for affected patients. While there are numerous neuropsychological test batteries, their use has been maximized in research settings with little attention paid to adaptability to clinical trials. However, some aspects of executive function are being incorporated into many recent or current clinical trials in neurology, usually as secondary outcome measures. Many neuropsychological assessment scales have been developed for use in various disease settings; however, some of the existing scales have questionable validity and there is no consensus on what methods should be used within or across studies or disease areas. The lack of consensus about the best tools or approaches creates a situation where based on the existing literature, it is not possible to compare the relative burden of various neurological conditions to each other or more importantly, to compare the relative benefits of one treatment over another on the same patient-centered outcome. Supporting a research agenda that will create a battery of domain specific Executive Function tasks would greatly increase the probability for more precise clinical assessment and integration in a large range of basic brain research. Goals of the Proposed Initiative The overall goal of this initiative would be to obtain a battery of tasks for EF that tap into its specific components that are comparable in animals and humans and the development of a battery of EF tasks with the specific characteristics such as: o focused on one or more of the following six domains: inhibition (response suppression); working memory (manipulation and maintenance of information; temporal organization (time & place); set shifting (mental flexibility); self monitoring (behavioral awareness, insight); abstraction (rules, categories). o modifiable (depending on individual protocols or paradigms and individual differences) o programmable; replicable (flexible across laboratories) o usable across species (rodents, monkeys, humans) and across age groups o adaptable for clinical trials o utilizes naturalistic situations (virtual reality) o includes functional outcomes (sensitive to treatment, training, drugs) Information Requested Information in the following areas could aid in the design of a possible future solicitation. We ask that interested organizations help identify critical criteria that would be germane to any such solicitation. The information supplied in any response to this request should address, but not be limited to the following: o General scientific approach to identifying content and developing measures, considering the current state-of the-art in qualitative and quantitative psychometric methods; o Overall estimation of the number of personnel required and specific expertise needed, with approximate level of effort required for each; o Availability of technology; o Target populations (e.g., source, characteristics, numbers needed for each phase); o Human subjects concerns; o Methods of evaluation of data; o Database/data management requirements; o Project timeline. This Request for Information (RFI) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government’s use of such information. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the Government’s evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this request for information or the Government’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked. All respondents are asked to indicate the type and size of your business organization, e.g., Large Business, Small Business, Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, HUBZone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other nonprofit organization. Responses should be limited to 20 pages, should be identified with NINDS RFI No. NOT-NS-04-012 and are due by May 3, 2004. Please submit three (3) copies of your response to: Helene Braun Contract Specialist Contracts Management Branch National Institute of Neurological Disorders and Stroke NIH 6001 Executive Boulevard, Room 3287 MSC 9531 Bethesda, Maryland 20892-9531. (for FedEx or courier, use: Rockville, MD 20852) E-mail responses, sent to hb106s@nih.gov, will also be accepted.
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