Attachment 2-Purchase Description.pdf

PURCHASE DESCRIPTION

1. Statement of Need and Purpose:

A transcranial magnetic stimulation system is needed to support the Study entitled, “Role of GABAergic transmission in auditory processing in Autism Spectrum Disorder”. The study has been reviewed and approved by the National Institute of Mental Health (NIMH) committee for the Scientific Review of Protocols (CSRP) and is now being reviewed by the National Institute of Health (NIH) Institutional Review Board (IRB).

2. Background Information and Objective:

The 2020 NIMH Strategic Plan for Research’s top goal is to “define brain mechanisms underlying complex behaviors”. The goal of the study entitled, “Role of GABAergic transmission in auditory processing in Autism Spectrum Disorder” is to define the brain mechanism underlying a core behavioral deficit of Autism Spectrum Disorder (ASD), language processing through an experimental therapeutics approach.

The transcranial magnetic stimulation system will allow for the targeted stimulation of language processing networks within the brain in order to transiently modulate the putative brain mechanism, GABAergic transmission. In doing so, we aim to define the causal link between the putative mechanism and the neurological and behavioral phenotype of ASD.

3. Generic Name of Product:

Transcranial Magnetic Stimulation System

4. Purchase Description:

Name Brand or Equal MagProX100 with MagOption Magnetic Stimulator System

Items supplied:

• MagVenture MagProX100 with MagOption Magnetic Stimulator

• Isolation Transformer

• Active and Blinded Sham Coils

• Coil Cooler for to prevent from overheating

• Software to allow for blinding of coils

• Cart with wheels and coil holder to allow for portability of the system

• Miscellaneous Cables and Connectors

• Shipping and Insurance

5. Salient characteristics

• Capable of delivering bi-phasic, bi-phasic burst, and mono-phasic waveform stimulation at frequencies of between .1 and 100Hz, with the ability to define stimulation frequency with .1Hz resolution.

• Capability to empirically measure and display current discharge through the transducer coil circuit (di/dt). The di/dt value is a measurement of the electrical flux through the coil and is measured, displayed and can be recorded for every stimulation. This is important to ensure that the device is calibrated and delivering the prescribed amount of stimulation.

• Capability to capture, record, and display EMG recordings coordinated with delivery of magnetic stimulation pulses. This will allow for efficient identification of motor threshold (appropriate intensity of stimulation for that individual participant).

• Inclusion of flexible arm for positioning and holding the stimulation coil stable anywhere on the participant’s scalp.

• Inclusion of a “figure of eight” coil with state-of-the-art focality.

• Capability of supporting double blind delivery of experimental TMS, including ability to utilize a transducer coil that facilitates delivery of active TMS, and sham TMS with concurrent electrical stimulation and a sham noise generator to mask the acoustic noise produced by the TMS coil (to mimic the auditory and somatic sensation of active TMS).

• The TMS coils generate a lot of current in order to produce the magnetic field strengths needed, therefore equipment safety is of utmost importance. Thus, system must include a tracking system with real-time diagnostic monitoring of the status of the coil (i.e. Coil temperature, magnetic field strength delivered, etc.) in order to optimize patient as well as operator safety.

• Inclusion of coil cooling system and a refrigeration cooling unit that keeps the coils from overheating and maintains the temperature of the coils between 18 and 20°C at all time.

• Security system designed to limit/ prevent unauthorized use. This is critical as the device will be stored in a secured yet shared space.

• Compatibility with Brainsight Neuronavigation System.

• 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.

6. Quantity:

One (1)

7. Delivery Date:

The Contractor shall deliver and install the equipment within Sixty (60) days after receipt of order to:

Point of Contact: to be provided at award Delivery address: 10 Center Drive, Bethesda, MD 20814

8. Period of Performance:

The Contractor shall warrant that the new equipment covering parts and labor for a minimum of one (1) year from the date of acceptance.