Notice Number: NOT-NS-05-006
Release Date: March 22, 2005
RFP Release Date: April 1, 2005
The National Institute of Neurological Disorders and Stroke (NINDS) has a requirement for an innovative approach to Executive Function (EF) measurement that will be responsive to the needs of researchers in a variety of neurological disorders and settings with a particular emphasis on measuring outcomes in clinical trials. 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. The proposed contract 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 contract 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. Cross-cultural issues are also important; the resulting tool must be applicable to the US Hispanic population and must be available in Spanish. The specific goals of the proposed contract are as follows: (1) to develop a core set of tasks that will address specific domains of Executive Function that is universal to patients with chronic neurological disorders; (2) to integrate the specific following characteristics in the NINDS Executive Function test battery: a) focused on two or more of the following six domains: inhibition (response suppression; interference resolution); working memory (manipulation and maintenance of information; temporal organization (time and place); set shifting (mental flexibility); self monitoring (behavioral awareness, insight); abstraction (rules, categories); b) modifiable (depending on individual protocols or paradigms and individual differences); c) portable (battery that can be administered in emergency room; physician offices); d) programmable; replicable (flexible across laboratories); e) usable across species (rodents, monkeys, humans) and across age groups; f) adaptable for clinical trials; g) utilizes naturalistic situations (virtual reality); and g) includes functional outcomes (sensitive to treatment, training, drugs). The proposed contract will be structured in two phases. Phase I will encompass qualitative research focusing on the identification of content area and the development of EF domain specific tasks. Phase II addresses the formal testing and refining of the final battery of EF tests.
It is anticipated that one cost-reimbursement type contract award will be made for a period of five years beginning on or about September 30, 2005. This acquisition has been designated as full and open competition under the North American Industrial Classification System (NAICS) code 541710. The solicitation will be available electronically on or about April 1, 2005. RFP NIH-NINDS-05-02 will be available at the FedBizOpps Website: http://www.fedbizopps.gov and at the NINDS public website: http://www.ninds.nih.gov/funding/funding_announcements/RFP_all.htm). Proposals will be due on or about May 31, 2005. Offerors are responsible for downloading their own copy of the solicitation and amendments and for routinely checking the Internet sites for any possible solicitation amendments that may be issued by the Government. All responsible sources may submit proposals which will be considered by the Government. This advertisement does not commit the Government to award a contract.
Inquiries may be directed to:
Contract Specialist, Contracts Management Branch, DER
National Institute of Neurological Disorders and Stroke, NIH
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Department of Health
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