This grant is for advancing clinical trial readiness for Functional Neurological Disorders (FNDs). FNDs, characterized by altered motor or sensory function, are highly prevalent, costly, and lead to significant disability, representing a major healthcare challenge. Diagnosis and management remain complex, with a critical need for universally agreed-upon diagnostic criteria, biomarkers, and robust laboratory-supported diagnosis. Current therapeutic interventions lack high-level evidence due to limitations in available outcome measures and difficulties in predicting treatment responses. This funding opportunity invites researchers to submit projects focused on validating essential biomarkers, endpoints, and clinical outcome assessments (COAs). The goal is to develop fit-for-purpose tools with defined contexts of use, ultimately enhancing the ability to conduct rigorous and effective clinical trials for FNDs.
Opportunity ID: 336363
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-053 |
| Funding Opportunity Title: | Clinical Trial Readiness for Functional Neurological Disorders (U01 Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 02, 2021 |
| Last Updated Date: | Nov 02, 2021 |
| Original Closing Date for Applications: | Nov 05, 2024 |
| Current Closing Date for Applications: | Nov 05, 2024 |
| Archive Date: | Dec 11, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Special district governments Native American tribal governments (Federally recognized) Independent school districts Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities County governments Private institutions of higher education For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | Functional Neurological Disorders (FNDs) are characterized by symptoms of altered voluntary motor or sensory function with clinical findings providing evidence of incompatibility between the symptoms and recognized neurological or medical conditions. FNDs are highly prevalent and associated with significant morbidity, health care costs, and even mortality. In some respects, this group of conditions sits at the intersection of neurology and psychiatry, but the majority of cases first come to the attention of neurologists. Management is complex and requires interdisciplinary approaches. Given the disability caused by the symptoms, and the high cost in healthcare utilization and loss of productivity, FNDs amount to a significant missed opportunity for therapeutic intervention and therefore, a healthcare crisis. Diagnosis and management of FNDs remain very challenging. Diagnostic criteria have been proposed but they are not universally agreed upon. Diagnosis is based on positive clinical findings, and can be supported by laboratory or ancillary investigation findings. Certain FND subtypes are more difficult to correctly diagnose than others. More importantly, laboratory-supported diagnosis is possible, and biomarkers can be developed, but significantly more research is needed in these areas to advance clinical management of FNDs. Therapies exist and have been studied in select populations but gathering high-level evidence through clinical trials is hampered by limitations in available outcome measures. Differential responses to treatments have been recorded, and thus, prediction of aggregate treatment response has been difficult. This FOA invites researchers to submit prospective clinical projects that address critical needs for clinical trial readiness in FNDs. Projects appropriate for this FOA include the validation of biomarkers, endpoints and clinical outcome assessments (COA) that are fit-for-purpose and have a defined context of use for clinical trials. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-053.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 336363 Full Announcement-PAR-22-053 -> PAR-22-053-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster OERWebmaster03@od.nih.gov Email: OERWebmaster03@od.nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00270426 | Jan 05, 2022 | Jan 24, 2023 | View | |
| FORMS-F | Use for due dates on or before January 24, 2022 | PKG00269992 | Jan 05, 2022 | Jan 24, 2022 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00277957 | Nov 04, 2022 | Nov 05, 2024 | View |
Package 1
Mandatory forms
336363 RR_SF424_5_0-5.0.pdf
336363 PHS398_CoverPageSupplement_5_0-5.0.pdf
336363 RR_OtherProjectInfo_1_4-1.4.pdf
336363 PerformanceSite_4_0-4.0.pdf
336363 RR_KeyPersonExpanded_4_0-4.0.pdf
336363 PHS398_ResearchPlan_4_0-4.0.pdf
336363 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
336363 RR_Budget_3_0-3.0.pdf
336363 RR_SubawardBudget30_3_0-3.0.pdf
336363 PHS398_ModularBudget_1_2-1.2.pdf
336363 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
336363 RR_SF424_2_0-2.0.pdf
336363 PHS398_CoverPageSupplement_5_0-5.0.pdf
336363 RR_OtherProjectInfo_1_4-1.4.pdf
336363 PerformanceSite_2_0-2.0.pdf
336363 RR_KeyPersonExpanded_2_0-2.0.pdf
336363 PHS398_ResearchPlan_4_0-4.0.pdf
336363 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
336363 RR_Budget_1_4-1.4.pdf
336363 RR_SubawardBudget30_1_4-1.4.pdf
336363 PHS398_ModularBudget_1_2-1.2.pdf
336363 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
336363 RR_SF424_5_0-5.0.pdf
336363 PHS398_CoverPageSupplement_5_0-5.0.pdf
336363 RR_OtherProjectInfo_1_4-1.4.pdf
336363 PerformanceSite_4_0-4.0.pdf
336363 RR_KeyPersonExpanded_4_0-4.0.pdf
336363 PHS398_ResearchPlan_5_0-5.0.pdf
336363 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
336363 RR_Budget_3_0-3.0.pdf
336363 RR_SubawardBudget30_3_0-3.0.pdf
336363 PHS398_ModularBudget_1_2-1.2.pdf
336363 PHS_AssignmentRequestForm_3_0-3.0.pdf
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