SAFE AND EFFECTIVE STIMULATION OF NEURAL TISSUE 

NIH GUIDE, Volume 26, Number 23, July 18, 1997

 

RFP AVAILABLE:  NIH-NINDS-97-09

 

P.T. 34



Keywords:

  Neural Stimulation 

 

National Institute of Neurological Disorders and Stroke

 

The Neural Prosthesis Program of the National Institute of

Neurological Disorders and Stroke (NINDS), National Institutes of

Health, is seeking a contract to develop cortical stimulating

microelectrodes and to evaluate the effects of electrical stimulation

on neural and surrounding tissue in non-human animals.  Studies on

intracortical stimulation with single penetrating microelectrodes

have established safe levels of stimulation under certain stimulating

conditions, but more information is needed about the safe limits for

multiple, closely spaced, penetrating microelectrodes such as would

be used in advanced visual prostheses.  Progress has been made on

understanding the causes of tissue damage that can occur at high

levels of stimulation.  In order to minimize tissue damage, more

information is needed on methods of preventing damage, the safety of

new biomaterials, as well as better methods of physically stabilizing

microelectrodes in neural tissue.  The possibility of using

multicontact, silicon microelectrodes with long shanks to access

buried cortical tissue also needs to be investigated.

Histopathological, neurochemical and neurophysiological techniques

must be applied to determine the effects of both acute and chronic

activation of cortical tissue.  Personnel with established expertise

in microelectrode design and fabrication, neurochemistry, and neural

histopathology are needed.

 

It is anticipated that one award will be made for a period of three

years in February 1998.  This is not a Request for Proposals (RFP).

 

THE SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY.  It will be

available on the following website:

http://ninds.nih.gov/cmb/rfp.htm.  The solicitation will be available

at this website 15 or more calendar days after the issuance of this

synopsis.  OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THIS

WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED.

NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED.  All

responsible sources may submit a proposal which shall be considered

by the agency.

 

INQUIRIES

 

Inquiries may be directed to:

 

Laurie A. Leonard

Contracts Management Branch

National Institute of Neurological Disorders and Stroke

7550 Wisconsin Avenue, Room 901, MSC 9190

Bethesda, MD  20892

Telephone:  (301) 496-1813

Email:  LL44S@NIH.GOV

 

MAGNESIUM IN CORONARIES (MAGIC)

 

NIH GUIDE, Volume 26, Number 23, July 18, 1997

 

RFP AVAILABLE:  NHLBI-HC-97-10

 

National Heart, Lung, and Blood Institute

 

The National Heart, Lung, and Blood Institute (NHLBI) is soliciting

proposals for a Clinical Trial Center (CTC) for a large, multicenter

clinical trial.  The purpose of the Magnesium in Coronaries (MAGIC)

Study is to determine whether patients with suspected acute

myocardial infarction and who are at a high risk for mortality can

benefit from early administration of intravenous magnesium. Patients

undergoing reperfusion therapy (thrombolytic therapy or primary

angioplasty) will be eligible provided magnesium c an be administered

before or at the same time as the reperfusion therapy. Patients with

acute myocardial infarction who do not receive thrombolytic therapy

or primary angioplasty will be eligible if they can begin magnesium

infusion within 6 hours of the onset of symptoms.  The primary

endpoint will be all cause mortality at 30 days following the index

event. Secondary endpoints will include development of cardiogenic

shock, ventricular fibrillation, congestive heart failure, and the

need for a temporary pacemaker.  The estimated sample size is 10,400

subjects with approximately 300 clinical sites participating in this

trial.  The Clinical Trial Center will have the following

responsibilities: 1) a leadership role in developing the manual of

operations and data collection forms; 2) provide 24-hour on call

assistance by a medical doctor to the clinical sites; 3) obtain

single project assurance numbers from the Department of Health and

Human Services, National Institutes of Health, Office for Protection

f rom Research Risks; 4) obtain clearances required by the Office of

Management and Budget under the Paperwork Reduction Act; 5) develop

procedures for random allocation of patients to treatment groups; 6)

design and implement procedures to evaluate clinical investigators;

7) develop procedures for and provide on-going quality control and

management of study data; 8) train clinical staff on procedures

required by the study protocol; 9) monitor adverse patient effects;

10) prepare clinical, technical, and statistical reports in the form

needed by a Data and Safety Monitoring Board to evaluate the safety

of the protocol to patients; 11) develop procedures to reimburse

clinical investigators for accepted data forms, such as participant

randomizations, events, follow-up forms, and death certificates; 12)

develop appropriate methods of analysis and presentation of data

collected during the course of the study; and 13) prepare a training

video and other training materials and distribute these items to a

maximum of 300 Investigators. The SIC Code is 8731: Commercial,

Physical and Biological Research. The anticipated period of

performance is three years, beginning on or about April 1, 1998. One

completion type cost-reimbursement contract will be awarded for this

randomized, placebo-controlled, double-blind study.

 

RFP NHLBI-HC-97-10 will be available on or about July 21, 1997 with

proposals due September 8, 1997.  This RFP may be accessed through

the NIH Home Page or the NIH Gopher by using the following elect

ronic mail addresses and instructions.  All amendments to the RFP

will be available through the Universal Resource Locator (URL) where

the original RFP No. NHLBI-HC-97-10 is located.  To access the RFP

through the NIH Gopher: Go to URL

gopher://gopher.nih.gov:70/11/res/rd-rfp. Select RFPs Available, then

NHLBI. A list of RFPs will appear. Select RFP No. NHLBI-HC-97-10.

 

To access the RFP through the World Wide Web (WWW), go to the NIH

Homepage at URL http://www.nih.gov. At the NIH Home Page, select

Grants and Contracts, then select Contracts Page. Next select NIH

Gopher Directory. The URL for the NIH Gopher Directory is

gopher://gopher.nih.gov:70/11/res. From the Gopher menu, select R&D

Request for Proposals, then select RFPs Available, then select NHLBI.

Select RFP No. NHLBI-HC-97-10. Follow the directions for a

Streamlined Technical RFP. Please note that the RFP for this

procurement has been revised to include only the Work Statement,

Deliverables and Reporting Requirements, Technical Evaluation

Criteria, and proposal preparation instructions.  All information

required to submit an offer is in the electronic RFP package.  This

advertisement does not commit the Government to award a contract.

 

INQUIRIES

 

All requests must cite RFP NHLBI-HC-97-10.  Requests for the RFP may

be in writing, or sent via the e-mail to:

 

Peggy Mills, Contract Specialist

Email:  pm39m@nih.gov

Telephone:  (301) 435-0351

FAX:  (301) 480-3430

 

No collect calls will be accepted.

 

.

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