Attachment 1 - Purchase Description_updated 03March2021.pdf

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

PURCHASE DESCRIPTION

1. Statement of Need and Purpose:

The National Institute of Mental Health (NIMH) on Section Development and Affective

Neuroscience (SDAN) conducts considerable research on various aspects of fear and pain.

This research requires very precise control of stimulus features, as the research involves work with children, a vulnerable population. Fear and pain must be manipulated in a way that creates emotions that are genuine but in no way traumatizing. Thermosensory Stimulator devices are unusual in that they possess the precise level of control that is needed to generate such manipulations. This has led the requested device to emerge as a standard in the field.

The SDAN would like to purchase two Thermosensory Stimulator devices for generating heat pain and examining fear conditioning in children in Building 10 and data analysis in Building 15k.

As previously discussed with the Board of Scientific Counselors (BSC) at the SDAN review, the gold-standard procedure for examining fear conditioning in humans relies on electric shock as the unconditioned stimulus (UCS). However, ethical concerns limit applications to children.

SDAN has used six alternative techniques to examine fear conditioning. Our two most aversive procedures, which rely on loud sounds as a UCS, clearly are useful, but they generate levels of conditioning that are weaker than generated by procedures using shock UCS. Moreover, habituation to the loud-sound UCS hinders repeated testing, necessary in longitudinal research.

Due to these limitations, SDAN began in 2014 to collaborate with Lauren Atlas, PhD, a tenure-track scientist in the National Center for Complementary and Integrative Health (NCCIH). Dr.

Atlas developed fear-conditioning techniques that rely on heat-pain UCS by adapting procedures from research on pain. These procedures rely on a Thermosensory Stimulator device to generate more robust changes in physiology and reported emotion than generated by our procedures utilizing loud sound UCS. Moreover, unlike response to a loud-sound UCS, which habituates following multiple exposures, response to heat-pain UCS remains stable on repeated testing. Finally, research on developmental psychophysics of pain thresholds relies extensively on the Thermosensory Stimulator devices to generate heat-pain in children. As a result, SDAN began to work with Dr. Atlas in June of 2015 to apply her heat-pain-based methods in our samples. Following early success, we now are ready to increase patient flow but can only do so with devices of our own.

2. Background Information and Objective:

The Section on Development and Affective Neuroscience (SDAN) is a laboratory designed to conduct psychophysiological and brain imaging studies in children and adolescents. A particular area of promising research involves examining the expectancy of pain, as can be manipulated using fear conditioning procedures. SDAN has conducted considerable work using various manipulations as part of fear conditioning.

The current project uses a manipulation of heat pain to study fear conditioning. This provides major insights on the underlying biological mechanisms of anxiety in children.

Such insights are important to developing novel treatments, designed to target perturbations in biology. SDAN has been successfully using a Thermosensory Stimulator device for the past few years (Abend et al., Journal of Psychiatry and Neuroscience, in press; Michalska, et al., Psychosomatic Medicine, 2018).

3. Generic Name of Product:

Thermosensory Stimulator

Purchase Description:

Thermosensory Stimulator is capable of rapid heating and cooling, which enables recording of both heat and cold evoked potentials via EEG. TTL IN and OUT allow full synchronization with the EEG device.

Salient characteristics:

SPECIFICATIONS

Thermode continuous active area 30x30 mm, 16x16 mm, Intra-oral Intra-vaginal FMRI compatibility Yes 30x30mm, 16x16mm, (dual-thermode configuration) Dual thermode port configuration Yes Temperature range 0°C – 53°C Temperature change rate range 0.113°C/sec Maximum duration at target temperature 600 sec Stimulation methods Limits, Levels, TSL, Chain, Pulses, Ramp and Hold, Search, VAS Search, CPM (for dual thermode protocols)

External control support Yes Absolute temperature accuracy ± 0.3°C Temperature repeatability ± 0.2°C Set-Point resolution 0.1 °C Display resolution 0.01 °C Baseline temperature 10°C – 45°C

Programmable parameters Method, Adaptation Temperature, Heating Rate, Cooling Rate, Number of Stimuli, ISI, Sound Option, Randomize Option, events

TTL output Voltage: ± 5V, Duration: <10[msec TTL Input Voltage: 3.3V- 5V Accessories 2 Button Response Unit (Y/N) Communication with host PC USB (2.0) Software Dedicated graphic based software –

Quantity:

3 EACH

4. Generic Name of Product:

Digital Thermal Calibration Kit

Purchase Description:

Calibration Kit can be used to check and recalibrate thermal stimulators to assure stimulation precision and safety. Calibration Kit Components.

• Calibration Device

• Thermal grease

• Thermode adaptor

• USB Communication cable

Salient characteristics:

• Calibration Jigs (per thermode type - 30x30mm, 16x16mm)

• Connection type: USB

• Compatible Software: Required

• Calibration Range: -3 to 54°C

• Sensor type: NTC

• Calibration device dimensions: 58.7 x 26 x 62.5 mm

• Sensor Accuracy: +/- 0.08°C

• Calibration Range: -3 to 54°C

• Calibrated according to NIST traceable standards

Quantity:

3 EACH

5. Delivery Date: Within 30 days after receipt of order.

6. Period of Performance: not applicable

7. Option(s): none