2024 Focused Ultrasound and ALS Research RFP

Eligibility

Applicants must hold a faculty appointment as a tenure-track assistant professor or higher rank at award activation. 

Additional Requirements 

For consideration, proposed projects must meet the following:  

• The project must be collaborative and require a team of at least one focused ultrasound researcher and one ALS expert. Both The ALS Association and the Focused Ultrasound Foundation are committed to building new research teams for ongoing collaborations moving forward.

The following metrics must be captured:

• Biological: analyses of blood samples pre- and post-focused ultrasound as well as histopathological evaluation when necessary 
• Acoustic: intensity/pressure (derated and non-derated), voltage/power/energy or whichever parameter used on the focused ultrasound device, pulsing parameters, sonication duration, frequency, and transducer characteristics, including diameter, focal depth, etc. 
• Imaging: ultrasound, MR protocols (MR thermometry, acoustic radiation force impulse, shearwave imaging, elastography, functional MRI), or nuclear imaging used for treatment monitoring 

Summary

The Focused Ultrasound Foundation and The ALS Association established a partnership funding program earlier this year with the goal of advancing the development of new focused ultrasound applications for the treatment and diagnosis of amyotrophic lateral sclerosis (ALS). The organizations will extend up to $1 million in funding to support research projects that address critical unanswered questions to treat ALS patients.   

While all projects submitted related to the use of focused ultrasound technology for ALS will be considered, the selection committee will prioritize projects that address the following two research areas. 

Research Area #1: Focused Ultrasound and Blood-Brain Barrier Opening (BBBO) 

The quantification of neurofilament light chain (NfL) in the blood and cerebrospinal fluid has emerged as a critical endpoint biomarker for pharmaceutical clinical trials in patients with ALS. In addition, studies have reported that the presence of NfL precedes clinical diagnosis by up to 12 months.  

The potential to detect NfL earlier in the disease could allow for the delivery of neuroprotective agents and even gene-targeted therapies that could significantly delay or halt the typical course of ALS. Focused ultrasound has been reported to safely and reversibly open the blood-brain barrier (BBB) within the motor cortex of patients with ALS, which could allow for the targeted delivery of therapeutics. This technique could also permit two-way trafficking of NfL and other analytes back into the circulation for earlier and more sensitive detection, characterization of disease subtypes, and disease monitoring.  

Some potential areas of interest include: 

• Investigating the safety of focused ultrasound BBBO in the motor strip by analyzing the kinetics of NfL release into the circulation and effects on motor function. 
• Enhancing our knowledge of biomarker release with focused ultrasound BBBO, including but not limited to proteomics, transcriptomics, and metabolomics. 
• Researching the ability of focused ultrasound BBBO to enhance the delivery of various classes of therapeutics for ALS, including but not limited to, existing approved medications, new antisense oligonucleotides (ASOs), gold nanoparticles, and gene-targeted therapies. 

Research Area #2: Focused Ultrasound and Neuromodulation (NM)

The ALS Foundation and Focused Ultrasound Foundation encourage projects that will improve the current quality and longevity of life for patients until a cure or new treatments are available. Recent technological advances with indwelling neuromodulators improve clinical function in ALS patients. Clinical trials using focused ultrasound are currently underway to assess noninvasive NM to treat an assortment of neurological diseases. We believe there is the potential to also noninvasively modulate the motor cortex with the goal of improving function in patients with ALS.    

Some potential areas of interest include: 

• Evaluating the safety of focused ultrasound NM in the motor strip by analyzing the kinetics of NfL release into the circulation and effects on motor function. 
• Demonstrating the feasibility and efficacy of focused ultrasound NM to the motor cortex. 

Funding 

A variety of research funding is available based on the type of project. 

• Preclinical research projects will be funded for one to two years with a budget range of $150,000 to $200,000. 
• Clinical research projects will be funded for one to three years (with an option to extend based on patient recruitment) with a budget range of $300,000 to $600,000 dependent upon protocol and number of patients.  

Project budgets outside of these ranges will be considered on a case-by-case basis with sufficient justification. All monetary figures are in USD. 

Application Submission

The application process will be completed in two-stages:

1. Letter of Intent (LOI). Those interested in applying for this funding opportunity must first submit a letter of intent describing the research plan by 3:00pm MT, Monday, October 2, 2023. All applications should be submitted via the Focused Ultrasound Foundation’s online portal. Please be sure to select the ALS track.

2. Full Research Proposal. Selected applicants will be invited to submit a full research proposal via the Foundation’s online portal. Applicants must obtain institutional approval from the University of Calgary prior to submitting their full proposal to the Focused Ultrasound Foundation.  Initiate required University of Calgary internal approvals by completing a Pre-Award/Application record in RMS (https://my.rms.ucalgary.ca/). Attach a copy of your complete full proposal materials and submit for approvals. Please ensure that you allow time for academic approvals prior to the Research Services Office internal review deadline of 12:00pm MT, November 28, 2023.

Overhead

10% of total direct costs

Application deadlines

RSO detailed review deadline

RSO final internal review deadline

Program application deadline

Application deadlines

Letter of Intent (LOI) Deadline

NOTE: Consult your Faculty Associate Dean (Research) (ADR) regarding Faculty-specific deadlines and submission processes.

Principal Investigators: Complete a Research Management System (RMS) record, including a copy of your complete application, and submit this for approvals in RMS.

Approvals: The University of Calgary requires that all funding applications be approved prior to submission. Approval requires signatures via RMS in the following order:

• Principal Investigator
• Department Head
• Faculty ADR/Dean
• Research Services (on behalf of the Vice-President Research)

Read the Meaning of Grant Signatures policy to understand what your approval means. Please see the agency guidelines for details about which signatures are required on your application, as it may differ from internal requirements.

Late submissions: Late submissions will only be accepted in cases of medical or family emergencies, or other exceptional circumstances. If you submit your RMS record to Research Services after the internal deadline has passed, you must secure additional approvals. Please read: Late Applications Process.