Key Dates

Related Announcements

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

This NINDS Notice of Special Interest (NOSI) announces the availability of administrative supplements to support hyperacute magnetic resonance imaging (MRI) of the brain in stroke patients to understand how lesion evolution and hyperacute brain changes affect cognitive trajectories and outcomes.

Background

Hyperacute neuroimaging is the standard of care for triaging stroke patients to thrombolysis, and more recently, endovascular therapy. Computed tomography (CT) has been the preferred modality for hyperacute neuroimaging (first / triage scan) of stroke patients due to its ease of use, widespread availability, quick scan times, and ability to accurately identify hemorrhagic and non-vascular causes of stroke. Rapid magnetic resonance imaging (MRI) protocols (~15 minutes) can replace CT in most cases, and MRI-based biomarkers of tissue injury can select ischemic stroke patients for thrombolysis when symptom onset is unknown (e.g. wake-up or unwitnessed strokes ; estimated to occur in 14 - 27% of cases).

Research has also suggested that hyperacute changes, such as perfusion abnormalities, blood brain barrier leakage, and loss of microstructural integrity, are relevant to stroke outcomes, but less is known about the effects on Alzheimer’s Disease and Alzheimer Disease Related Dementia (AD/ADRD). The NINDS will provide supplements to eligible active awards to examine hyperacute changes on MRI in stroke patients that aid in treatment decisions and/or assessing susceptibility/risk and prognosis related to AD/ADRD outcomes (Alzheimer Disease, Vascular contributions to Cognitive Impairment and Dementia (VCID), Lewy Body Dementia, and Frontotemporal degeneration).

Research Objectives

The primary scientific goals of this administrative supplement are to perform MRI in hyperacute ischemic stroke patients (triage/first scan) and to analyze the potential relationships between stroke and AD/ADRD imaging, clinical, and biomarker data, in order to allow for future evaluation of outcomes and associated factors. Additionally, the NINDS appreciates the logistical challenges of MRI in hyperacute ischemic stroke treatment settings and aims to facilitate research programs in partnering with health care systems interested in transitioning to an MRI first paradigm. Budget items related to logistics (e.g. MRI technician time, patient navigator time) are allowed in addition to items related to data acquisition, management, analysis, and sequence development. Research topics of interest for this administrative supplement may include, but are not limited to:

• Blood brain barrier breakdown on the first (triage) scan and within 24 hours of symptom onset in hemorrhagic and ischemic stroke patients who have AD/ADRD or are at risk of progression.
• Perfusion abnormalities identified on the first (triage) scan and within 24 hours in ischemic stroke patients that are persistent, or resistant to thrombolytic or endovascular treatment, among patients who have AD/ADRD or are at risk of progression.
• Diffusion imaging abnormalities on the first (triage) scan and within 24 hours of symptom onset in hemorrhagic and ischemic stroke patients who have AD/ADRD diagnoses or are at risk of progression.
• Susceptibility changes (e.g. T2* gradient echo, susceptibility weighted imaging, quantitative susceptibility mapping) on the first (triage) scan and within 24 hours of symptom onset in hemorrhagic and ischemic stroke patients who have AD/ADRD or are at risk of progression.
• Development of novel stroke sensitive sequences sensitive to AD/ADRD that could be implemented within a rapid MRI protocol.
• Obtaining clinical data and biomarker data relevant for longitudinal clinical research on stroke and AD/ADRD outcomes.
• Utilization of clinical data and biomarker standards established for VCID by the MarkVCID and DISCOVERY networks is strongly encouraged, as well as the use of NINDS Common Data Elements as appropriate.

Studies proposed in the supplement application must be within scope of the original parent application’s research. If an investigator is unsure whether their supplemental project would be considered within scope, then they should contact the appropriate program officer to discuss the proposed studies.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date(s) May 5, 2021, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include NOT-NS-21-038" (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Requests may be for two years of support only.
• Application budgets must reflect the actual needs of the proposed project. Supplement budget requests may not exceed $330,000 per year in direct costs or 100% of the direct costs of the current year of the parent award (exclusive of Facilities and Administrative costs on sub-contracts), whichever amount is lower. Applications that want to propose higher budgets must receive permission from the project officer and IC Contact prior to submission.
  • Given the significant workflow changes required to shift to MRI first, NINDS will milestone the award to include a planning period that will be administratively reviewed before further funds are released.
  • Specifically, supplements will have one milestone: full preparation to perform hyperacute MRI scans on stroke patients. This planning period should have a separate budget and should be a maximum of 6 months. The transition to MRI scans will be triggered by this milestone.
• Awards made under this NOSI are limited to one per parent award.
• Applicants must have the resources and ability to provide evidenced clinical care and perform the research work without critically impacting other high-priority, on-going NINDS research programs.
• The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
• The Research Strategy section of the application is limited to 6 pages.
• Eligibility criteria:
  • Existing awardees of NINDS sponsored stroke or AD/ADRD grants.
• The application Abstract section should describe the proposed supplement and the Research Strategy section should include a summary or abstract of the funded parent award or project. The Research Strategy should state the relevance to the parent award and AD/ADRD, and articulate the component(s) and any IC-specific priorities that the supplement is addressing.
• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

Carlos C. Faraco, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-496-9135
E-mail: carlos.faraco@ninds.nih.gov