D1 Attach 1 PD Purchase Description.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

1. Statement of Need and Purpose:

The Magnetic Resonance Imaging (MRI) compatible Brainsight Navigator for non-invasive brain stimulation (NIBS) is needed to support the Study entitled, “Non-invasive Brain Stimulation Technique Development: Substudy 3 (Controlling Ongoing Cortical State during NIBS with Neurofeedback)" in order to precisely target the Transcranial Magnetic Stimulation (TMS) induced magnetic and electric field for concurrent TMS/fMRI projects based on individually determined locations and orientations. The Brainsight system is compatible with the MagVenture TMS Device that is also being used in the same study. The system includes all software and hardware and all of the components have been determined to be MRI safe.

2. Background Information and Objective:

The NIMH Strategic Plan for Research’s top goal is to “define brain mechanisms underlying complex behaviors”. The goal of the study entitled, “Non-invasive Brain Stimulation Technique Development: Substudy 3 (Controlling Ongoing Cortical State during NIBS with Neurofeedback)" is to explore the use of real-time fMRI neurofeedback to control the activated state of the amygdala while it is targeted transynaptically with short trains of 5 Hz rTMS using individualized fMRI-based targeting.

As there is significant inter-individual variability in functional network architecture and thus optimal region to modulate the desired brain regions and functional networks, the Brainsight System described will allow for individualized targeting. The individual’s functional and structural brain MRI will be uploaded into the system and be used to target the transcranial magnetic stimulation to a precise, individualized brain region while the person is lying in the MRI scanner. Rogue Research, Inc is the sole source of this device (see attached sole source letter).

3. Generic Name of Product:

MRI compatible Neuronavigation System for TMS

4. Purchase Description:

Product brand name: Brainsight Navigator for Non-Invasive Brain Stimulation (NIBS) with Computer and Electromyography (EMG), and Upgrade kit for MRI compatibility Manufacturer: LES RECHERCHES ROGUE INC or Rogue Research

Items supplied:

• Brainsight for NIBS with computer & EMG o Brainsight Neuronavigation Software for TMS w. 5 years of updates o Northern Digital Polaris Lyra, Pwr supply & cables o Camera Stand for Lyra o Complete Tracker Kit (pointer, coil tracker, subject tracker, calibration tool, subject head tracker elastic band, subject tracker glasses, 1 coil tracker fixation adapter, 1 coil calibration jig, 3 extra reflective spheres) o Apple Mac Minicomputer (24.0GB RAM, 27" 5k Apple Studio Monitor)

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs o I/O box w. 2 TTL trigger inputs one switch compatible input & 3 Ethernet ports o 2 channel MEP amplifiers opto-isolation unit & isolation transformer o Mobile Trolley

• Upgrade kit for MRI compatibility (with Vega) o NDI Vega camera with MRI compatible stand and Optical Ethernet adapter o MRI compatible Tracker Kit (pointer, coil tracker, subject tracker) with adapter for MagVenture MRI coil.

• Technical Support:

o Brainsight Software: 5 years of updates, o Computer: 3 Years (AppleCare warranty) o Other hardware: 1 year, parts & labour for manufacturer defects

5. Salient characteristics

• Incorporation of the most state of the art current modelling software to estimate magnetic and electrical current strength and trajectories.

• Automatic curvilinear reconstruction, skin reconstruction, multiple overlays, and easy interface with TMS equipment.

• A computer is provided with the added capability of acquiring 2 channels of EMG data from built-in EMG amplifiers for precise motor threshold determination.

• Portability. This device fits on a wheeled cart suitable for easy and safe transport from the storage space to the exam room where it will be used.

• MRI compatibility. All of the components in this system are safe to use in the MRI environment.

6. Quantity: One (1) x Brainsight Navigator for Non-Invasive Brain Stimulation (NIBS) with

Computer and Electromyography (EMG), and Upgrade kit for MRI compatibility

7. Delivery Date:

60 days from date of purchase.

Ship to:

NIH/NIMH

Neurodevelopmental and Behavioral Phenotyping Service & Noninvasive Neuromodulation Unit, Experimental Therapeutics and Pathophysiology Branch 10 Center Drive Bldg. 10, Room 4N238 Bethesda, MD, 20814

8. Period of Performance:

N/A

9. Option(s):

N/A