SOURCES SOUGHT
A -- Support of USAMMDA's Hyperbaric Oxygen Program Management Office and conduct of clinical trials using hyperbaric oxygen to determine the feasibility of treating mild traumatic brain injury (mTBI) in wounded warriors.
- Notice Date
- 8/25/2015
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH15-RFI-HBO2
- Response Due
- 9/21/2015
- Archive Date
- 10/24/2015
- Point of Contact
- Shannyn Scassero, 301-619-2640
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(shannyn.scassero.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- 1.0 SUBJECT: In support of the U.S. Army Medical Materiel Development Activity's (USAMMDA) mission the Hyperbaric Oxygen Program Management Office is conducting clinical trials in the area of hyperbaric oxygen to determine the feasibility of treating mild traumatic brain injury (mTBI) in wounded warriors. The current on-going trial, quote mark Development of Normative Datasets for Assessments Planned for Use in Patients with Mild Traumatic Brain Injury (NORMAL) quote mark, has three (3) Primary Objectives; 1) To develop a database from normal healthy participants for the same outcomes used in a program of studies of hyperbaric oxygen (HBO2) vs. sham control in participants with persistent post-concussive symptoms; 2) To characterize the distribution of responses and change in responses over time for each of the outcomes and to examine associations between measures within a given normal participant and across participant characteristics such as age and gender; and 3) To evaluate the test-retest reliability of a series of assessments anticipated for use in the primary, secondary, and exploratory outcomes of this program of studies. The NORMAL study is assigned the Institutional Review board (IRB) number M-10313. This study is performed under the sponsorship of the Office of the Surgeon General, Army Investigational New Drug (IND). The quote mark Brain Injury and Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury (BIMA) quote mark study has three Primary Objectives; 1) To obtain pilot data that will complement results from another pilot study (HOPPS); 2) Will describe the brain function and anatomy of active duty personnel and Veterans with PCS who are symptomatic at least 3 months but no more than 5 years after mild traumatic brain injury; and 3) Explore potential associations between changes in function, anatomy, and participant reported outcomes. The BIMA study is assigned the Institutional Review board (IRB) IRB Log Number M-10226. This study is performed under the sponsorship of the Office of the Surgeon General, Army Investigational New Drug (IND). Both studies are performed under the sponsorship of the Office of the Surgeon General, Army Investigational New Drug (IND) number 104678. 2.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. 3.0 DESCRIPTION: USAMMDA has a requirement to complete all six month follow-up assessments with study subjects as described in the protocol by 31 January 2016. - Neuropsychological Assessments to include Neurobehavioral Symptoms Inventory (NSI), Ohio State University (OSU) TBI Identification Method (OSU TBI-ID), Center for Epidemiological Studies - Depression Scale (CES-D), Post-Traumatic Stress Disorder Checklist - Civilian Version (PCL- C), World Health Organization Quality of Life (WHOQOL-BREF), RAND-36 Health Survey, Satisfaction With Life Scale (SWLS). - Neurological Function Testing to include Sharpened Romberg Test (SRT), Romberg Test (RT), and Audiology and Vestibular Evaluation. - Audiology and Vestibular Evaluation to include Vestibular Symptoms Questionnaire (VSQ), Peripheral and Central Auditory Examination, Clinical Vestibular Assessments, Videonystagmography, Computerized Dynamic Posturography and Dynamic Visual Acuity, Rotational Vestibular Test, Dynavision, VORTEQ VOR Assessment, Ocular and Cervical Vestibular Evoked Myogenic Potentials (oVEMPs and cVEMPs). - Visual Systems to include Static and Dynamic Visual Acuity (DVA) Assessments, Refractive Error (Autorefractor), Oculomotor Exam, Retinal Fundoscopy, Eye Tracking. - Autonomic Function to include 24-Hour Holter Monitor and Motion Detection. - Laboratory Testing to include blood draws to conduct Beta-Human Chorionic Gonadotropin (beta-HCG), Comprehensive Metabolic Panel (CMP), Illicit Drug Urinalysis, and Pregnancy Urinalysis. - Neuroimaging to include Magnetic Resonance Imaging (MRI), Detailed Volumetric Anatomical Imaging, Diffuse Tensor Imaging (DTI), Proton Magnetic Resonance Spectroscopy (MRS), Functional MRI (fMRI), Arterial Spin Labeling (ASL) MRI. - Computed Tomography Angiography (CTA). The contractor shall perform noncontrast-enhanced computed tomography (NECT), contrast-enhanced computed tomography (CECT), CTA and Computed Tomography Perfusion (CTP) sequences and is collectively referred to as 4DCTAP. - The vendor shall be asked to contribute to the writing of journals and manuscripts in addition to presenting posters, oral talks and abstracts at scientific meetings. 4.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish in writing, a 2-3 page (not including cover page, index or list of references) synopsis of their ability to conduct clinical trials and support data analysis. Companies responding to this notice must provide complete contact information (telephone, address, email address). Responders must identify their company's business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Please also include information regarding any prior experience with U.S. Government contracts and experience working on clinical trials involving live virus vaccines and regulated by the US Food and Drug Adminstration (FDA). 5.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Shannyn Scassero at shannyn.scassero.civ@mail.mil no later than the close of business 21 SEP 15. Telephonic communication will not be considered as submission or receive response.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH15-RFI-HBO2/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN03854975-W 20150827/150826000004-9bdb3f75ca34480a71307ae76d230649 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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