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The Letter of Intent allows a prospective investigator an efficient means to thoroughly convey a research concept to the Clinical Review Committee without the time expenditure of completing a full proposal.

Please complete the Letter of Intent Form and submit to the Clinical Review Committee:

Often, much of the Clinical Review Committee time is spent tracking down relevant information before a thorough review of the study can occur. Providing the following criteria should expedite the process of review and, accordingly, our decision on supporting your project.

Title: A title for your proposed study should be included in your application. This title should be consistent with the title to be used for all administrative, legal and regulatory documents associated with the proposed study.

Contact information: Please provide detailed contact information for the principal investigator, including mailing address (suitable for postal and express deliveries), phone numbers, e-mail, and any other preferred means of contact.

Objective: A primary research hypothesis should be stated. This primary objective may then be followed by secondary objectives. The objective of the study should include a comprehensive discussion of clinical/scientific relevance of the proposed research, how data is to be collected, measures to be employed and the expected outcomes.

Please provide rationale for your study. Although it is not required, you may wish to attach selected reference materials cited.

Study Outcomes: As an extension of study rationale, please indicate how this study will impact the understanding and/or therapeutic use of VNS Therapy.

Study Population: Any study population that includes high risk will be carefully scrutinized. High risk includes, but is not limited to patients with greater than normal suicidal or homicidal tendencies, those who are likely to harm themselves or others (e.g., prisoners or patients at high risk for self-mutilation, etc.), and medically unstable patients. Please consider the population carefully.

A simple, yet important element for Clinical Research Committee review of every study submission is the sample size. Proposals lacking this information significantly reduce the ability to critically analyze the study and will delay a decision until the information has been obtained.

Inclusion/Exclusion Criteria: Please indicate whether the inclusion/exclusion criteria for your study are consistent with product labeling. List and provide rationale for any inclusion/exclusion criteria not described in the product labeling.

Scope/Methodology: Generally, the Clinical Research Committee puts emphasis on pilot clinical studies related to uses of VNS Therapy within-label for refractory epilepsy and/or treatment resistant depression. Pilot clinical/animal studies can be completed relatively quickly, resulting in greater opportunities for early presentation and/or publication of data relating to VNS Therapy. Rigorous methodology and validated outcome measures are preferred. Please list all scales/outcome measures that will be utilized in this study. Any studies attempting statistical significance should have appropriate sample size calculations and detailed statistical plans.

Institutional Review Board (IRB): Please indicate which IRB will be reviewing the study protocol.

Budget: Please provide the overall budget for the proposed study. Please include any IRB fees and other administrative fees. The budget should be appropriate for the particular procedures and/or work to be performed.

Publication Goal: A major goal for Extramural Research Studies is to obtain data in provocative research areas. A key component to this is data publication and presentation. Please include a publication/presentation strategy with each proposal (e.g. where the data will be submitted to be considered for publication and/or for conference {poster or symposium} presentation).

Supplementary Material: In addition to the protocol, please provide a copy of your current CV, as well as CV’s of all sub-investigators, a copy of any scales you plan to use in the study, and any relevant publications supporting the proposed area of study (e.g. articles you may have cited in the proposal).