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Innovative Treatments in Disorders of Consciousness (ITDC) Grant Program

MRI brain scan

Spaulding Rehabilitation announces the following funding opportunity to generate and initiate disruptive ideas in the treatment of patients with disorders of consciousness and other “slow-to-recover” brain injuries.

This award funds projects that create infrastructure to enable prospective multicenter RCTs (including adaptive platform trials) and/or evaluate biologically plausible treatments. Acquisition of pilot data for larger multicenter studies is a key aim of this initiative.

Applying for this opportunity is a two-step process. Applicants must first submit a Letter of Intent (LOI), 2-page maximum. Applicants will then be advanced to the next round and invited to submit a full proposal.

LOI submission window expected to open in Spring 2024. Email SRNOutcomesCenter@partners.org to be notified once more details are available and the LOI window opens.

Background

Disorders of consciousness (DoC) – including coma, vegetative state, and minimally conscious state – are highly prevalent with estimates in the United States (2018)1 of:

  • up to 42,000 people in a coma and vegetative state
  • up to 280,000 in a minimally conscious state.

The landscape of DoC management is fraught with challenges. Diagnosis is difficult, with no laboratory nor imaging tests to detect consciousness. Published estimates of misdiagnosis among people with DoC are around 40%. No treatments are available to prevent secondary effects of primary brain injury. There is only one proven post-acute treatment available with narrow indications – amantadine hydrochloride.

A 2020 Symposium from the Curing Coma Campaign2 laid out research targets across six areas: defining endotypes/phenotypes, biomarkers, proof-of-concept clinical trials, prognostication, long-term recovery, and large data sets. Advances in our understanding of brain pathophysiology and biotechnology offer new avenues to improve diagnosis and treatment through research. The below table lists potential areas of exploration for applicants to consider. It is not an exhaustive list, and applicants are not limited to the below topics.

Knowledge Gap Area of Exploration
Infrastructure for clinical trials and observational studies Establish infrastructure such as a multicenter DoC network or Model System, focused on a specific research question
Poor understanding of neurobiological mechanisms underlying consciousness/DoC Connectomics / Circuit mapping
Patient classification Phenotyping / Endotyping
Long-term outcome Trajectory modeling
Lack of biomarkers Validation of diagnostic, prognostic, response biomarkers
Prognostication Modeling, large datasets, machine learning
Effective treatments for neuroprotection & post-acute recovery Focus on innovative proposals, from proof-of-concept to comparative effectiveness drug (re-purposed agents) and device (DBS, tDCS, TMS, VNS, LIFUP) studies

 

1Giacino et al. “Comprehensive systematic review update summary: disorders of consciousness.” Neurology, 2018 Sept. 4; 91(10:461–470)

2Claassen J, Akbari Y, Alexander S, et al. Proceedings of the First Curing Coma Campaign NIH Symposium: Challenging the Future of Research for Coma and Disorders of Consciousness. Neurocrit Care. 2021;35(Suppl 1):4-23. doi:10.1007/s12028-021-01260-x