Notice Number: NOT-MH-17-051

Key Dates
Release Date: September 29, 2017

Issued by
National Institute of Mental Health (NIMH)

Purpose

The purpose of this Notice is to clarify the language concerning realistic head/electric field modeling for device-based studies in the R33 phase in RFA-MH-17-602.

It is NIMH’s expectation that applicants will provide a figure demonstrating the modeled stimulation dosage. This figure should include a figure legend/scale bar with labeled axes and demarcate relevant stimulation thresholds, when relevant. If multiple targets are proposed, models should be provided to demonstrate stimulation capabilities at each site (if individualized targets are to be used, models covering multiple general targets may be used).

Additionally, individualized targeting should be used throughout the proposed application, not just for the example figure. Each subject should be given individualized stimulation that matches unique aspects of the subject’s anatomy, in order to more accurately target the stimulation in the subject.

Part 2. Section I. Funding Opportunity Description

Additional information for specific intervention types

Current language:

Medical devices. All aspects of delivered dose should be thoroughly defined, modeled, and where appropriate, measured, including its spatial and temporal components, as well as the context of its administration. Characterization of the spatial aspects of delivered dose for electromagnetic devices should use realistic head modeling to simulate the amplitude of the electric field induced across the brain, and should evaluate degree of target to non-target stimulation. Characterization of temporal elements of dosage should specify pulse shape, pulse direction, frequency, train duration, inter-train interval, etc.

Revised Language:

Medical devices. All aspects of delivered dose should be thoroughly defined, modeled, and where appropriate, measured, including its spatial and temporal components, as well as the context of its administration. Characterization of the spatial aspects of delivered dose for electromagnetic devices should use realistic head modeling to simulate the amplitude of the electric field induced across the brain, and should evaluate degree of target to non-target stimulation. A figure should be provided demonstrating this head modeling, including labeled axes on figure legends/scale bars and demarcating a threshold for activation, when relevant. If multiple targets are proposed, models should be provided to demonstrate stimulation capabilities at each site (if individualized targets are to be used, models covering multiple general targets may be used). Additionally, individualized targeting should be used throughout the proposed application, not just for the example figure. Each subject should be given individualized stimulation that matches unique aspects of their anatomy. Characterization of temporal elements of dosage should specify pulse shape, pulse direction, frequency, train duration, inter-train interval, etc.

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

For Pediatric Studies
Margaret Grabb, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3563
Email: mgrabb@mail.nih.gov

For Adult Device Studies
David McMullen, M.D.
National Institute of Mental Health (NIMH)
Telephone:  301-451-0180
Email: david.mcmullen@nih.gov

For Geriatric Studies
Jovier Evans, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  301-443-6328
Email: jevans1@mail.nih.gov