Clinical Research Oriented Workshop (CROW) Meeting: January 14, 2016

Present:  Marianne Burke, Nancy Gell, Kairn Kelley, Jennifer Oshita, Gail Rose, Adam Sprouse-Blum, Connie van Eeghen

Start Up:  Introductions – welcome to Jennifer.

1.                  Discussion: Adam’s next research project on Migraine

a.       Review of his pilot study (2013 publication) on the use of cold therapy for Migraine

                                                  i.      Resulted in significant results, with limitations, and a product that is undergoing patent approval and is currently being sold by someone else (note: a timer added to the product, along with linkage to a smartphone, could add some additional distinctive features)

b.      Planning a proposal to SPARK (health related, novel interventions)

                                                  i.      Design plan: randomized concurrent controlled trial targeted carotid cooling in the treatment of the migraine patient with or without cross-over; rolling admissions

                                                ii.      Inclusion: adult patients (18-65), male or female, with episodic migraine (2-14 events/month)

1.      Need justification to exclude over 65 year old subjects

2.      Consider including everyone who shows up, including pregnant patients

                                              iii.      Exclusion: known or suspected disease of carotid artery, no change in preventive agent in last month or three months, “medication over-use” headache

                                              iv.      Process

1.      Patient identified

2.      Contact information given to medical assistant (paid for by SPARK)

3.      Review inclusion/exclusion criteria by phone

4.      Delivery of device, informed consent and demonstration

5.      Record data (0-4 attacks over 6(?) weeks

6.      MA pick up device and data

7.      Exit interview w/ blinding testing

8.      Submit data directly to statistician

                                                v.      Device: neck wrap connected to circulation device, set for a particular temperature

1.      Stays colder, colder longer, better controlled

2.      UVM has equipment to measure brain temperature

3.      Cost: over $2K/device

c.       Endpoints

                                                  i.      Primary: Pain free at 2 hours (0=no headache, 1=mild, 2=moderate, 3=severe) (typical measure for acute treatment)

                                                ii.      Secondary: recurrence of headache 2-48 hours after administration, nausea, phono-/photophobia, rescue medication use

d.      Purpose of the study: efficacy or effectiveness

                                                  i.      How does cooling effect brain temperature (fMRI, UVM research support)

                                                ii.      Do patients who use this intervention feel better

e.       Goals

                                                  i.      Find a source to pay for the device and the cost of the study

                                                ii.      Continue work in CTS: research and academics

                                              iii.      Staying for a research year, which includes clinical (1 day research now; more later)

                                              iv.      Consider accelerating publication rate to strengthen future applications (e.g. K award)

2.                  Next Workshop Meeting(s): NOTE NEW TIME: Thursdays, 1:30 p.m. – 2:30 p.m., at Given Courtyard South Level 4.   

a.       January 21, 2016:  Rodger - CDC Grant Diabetes Data Pull

b.      January 28, 2016:

c.       February 4, 2016

Recorder: Connie van Eeghen