Contact Points
Primary Contract Specialist
Secondary Contracting Officer
Therefore, our only current option is to purchase a Somatics Thymatron® System IV to use for the study.
- Statement of Need and Purpose:
The Thymatron® System IV ECT Instrument is needed to administer an experimental brain stimulation therapy as part of a proposed Noninvasive Neuromodulation Unit (NNU) protocol, “A Feasibility Study of Transcranial Electric Stimulation Therapy (TEST) for treatment resistant depression (TRD)”. This device will be a backup device that will be used if technical issues arise with the current device. Having this backup device is critical to preventing disruption of a research participant’s experimental treatment during the study. Disruption of experimental treatment could have significant adverse clinical effects for the participant, e.g., worsening of depressive symptoms, and significant adverse scientific effects for the study in that it would exclude use of data from the participant if the technical issue could not be resolved before the next scheduled treatment. Treatments are given Mondays, Wednesdays, and Fridays. Shipping the device to the manufacturer for repair, repairing it, and shipping it back cannot be accomplished within 48 hours. The EctoBrain Testing training device accessory is needed to train ECT practitioners and to interrogate the device to assess its function as a measure of quality control.
- Background Information and Objective:
The mission of the NIMH Noninvasive Neuromodulation Unit is to promote the development and refinement of new and existing non-invasive neuromodulation technologies with the goal of furthering the understanding and treatment of mental illnesses using transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), magnetic seizure therapy (MST), vagus nerve stimulation (VNS), deep brain stimulation (DBS), and other devices.
The overall objective of “A Feasibility Study of Transcranial Electric Stimulation Therapy (TEST) for treatment resistant depression (TRD)” is to assess whether a type of noninvasive brain stimulation that is like electroconvulsive therapy (ECT) but uses a lower dose of current so as not to cause a seizure can cause less side effects than ECT, while remaining as effective as ECT for TRD. ECT is the most effective treatment for TRD, but it is very underused due to its side effects, primarily its adverse effects on memory. The study could have a major effect on TRD therapy by determining whether a seizure is necessary for the antidepressant effect of ECT. If a seizure is not required, then approaches like TEST could eventually be used in clinical practice to reach a large group of individuals with TRD who have rejected ECT over concern over side effects.
TEST can be administered with a standard, unmodified FDA-cleared ECT device with the dosing set at a very low level so as not to induce a seizure. There are only two manufacturers of FDA-cleared ECT devices, Somatics LLC and MECTA Corp. The MECTA device would need to be modified to include a lower frequency setting to enable the low range dosing. Due to the coronavirus pandemic, MECTA, is unable to take on new research commitments including modifying a device for the TEST study.
Therefore, our only current option is to purchase a Somatics Thymatron® System IV to use for the study.
- Purchase Description:
- Brand name: Thymatron® System IV ECT Instrument
- With accessories: EctoBrain Testing – Training device
- Manufacturer: Somatics, LLC (Venice, FL, USA)
- Salient characteristics:
- Made in the USA
- CSA Approved
- Adjust dose with a single dial
- Prints 4 channels plus digital heart rate
- Important EEG measures require no special training
- Optimal stimulus automatically selected at every dose
- Store entire treatment on palm or windows computer
Ultra-brief therapy at every stimulus dose
Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.
All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.
All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.