Clinical Trial Readiness for Functional Neurological Disorders (U01 Clinical Trial Optional)

The Functional Neurological Disorders (FNDs) Clinical Trial Readiness Grant welcomes researchers to submit prospective clinical projects focusing on preparing for potentially promising clinical trials in the field of FNDs. FNDs are medical conditions characterized by altered voluntary motor or sensory function, a type of disorders that comfortably sits at the intersection of neurology and psychiatry. Symptoms often don't line up with recognized neurological or medical conditions. They're fairly widespread and come with considerable morbidity, healthcare costs, and even mortality.

Most patients with FNDs first interact with neurologists. Management of FNDs is complex, involves interdisciplinary approaches, and poses a significant healthcare challenge due to the disability caused by the symptoms and the high cost in healthcare utilization and loss of productivity. This makes the FNDs significantly unexploited in terms of therapeutic intervention, hence implying a notable healthcare crisis.

Diagnosing and managing FNDs continues to pose considerable difficulties. While diagnostic criteria exist, they lack universal consensus. Currently, diagnosis is largely reliant on positive clinical findings, supported often but not always by laboratory or ancillary investigation results. Some types of FNDs are more difficult to diagnose correctly than others.

While therapies exist and have been studied in select populations, collecting substantial evidence through clinical trials suffers due to inadequate outcome measures. There have been varying responses to treatments, making it difficult to accurately predict overall treatment response. Therefore, more research is critically needed in these areas to enhance clinical management of FNDs.

The grant aims to address these very challenges by inviting projects that focus on the validation of biomarkers, endpoints, and clinical outcome assessments (COA). An emphasis is placed on those that are "fit-for-purpose" for clinical trials and have clearly defined contexts of use.