NINDS is issuing this Notice of Special Interest to encourage the submission of applications focused on the development and validation of biomarkers for functional neurological disorders (FND).
FND are a complex and heterogeneous group of neuropsychiatric syndromes. They are characterized by symptoms of altered voluntary motor or sensory function and frequently have comorbid medical, neurological, and psychiatric disorders. Although patients with FND represent the second commonest category of referrals to neurology outpatient clinics after headache, management is complex and requires interdisciplinary approaches. The high prevalence of FND, the disability caused by symptoms, high cost in healthcare utilization and loss of productivity points to an important opportunity for development of effective therapeutic interventions.
This common, disabling, and costly group of conditions sits at the intersection of neurology and psychiatry. In the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM) the term functional is used as the primary descriptor in the term for this group of conditions, although the term conversion disorder is still accepted as an alternative expression that acknowledges unconscious processes in patients. However, this term emphasizes the implicit inference of causative psychological stressors, which are not always present or may not be readily identifiable.
Diagnostic criteria for FND have been proposed, but are not universally accepted, and have varying rates of interrater reliability, depending on the symptom presentation (high for non-epileptic psychogenic seizures; poor for other FND). For this reason, diagnosis remains very challenging.
Recent recommendations suggest that diagnosis should be based on positive clinical findings and supported, when necessary, by laboratory or ancillary investigation findings. Certain FND subtypes are more difficult to correctly diagnose than others. More importantly, laboratory-supported diagnosis is possible. Valid and reliable laboratory/ ancillary investigations depend on the identification and development of biomarkers. This will facilitate the research needed to advance clinical management of FNDs.
This notice applies to due dates on or after February 5, 2022 and subsequent receipt dates through January 8, 2025.
Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.
- PAR-19-315 - Discovery of Biomarkers and Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)
- PAR-21-056 - Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
- PAR-21-057 - Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
- PAR-21-058 - Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
- PAR-21-059 - Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
Application Due Dates: February 22, 2021, June 22, 2021, February 22, 2022, June 22, 2022, February 22, 2023, and June 22, 2023.
NOT-NS-22-010