Thursday, January 14, 2016

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

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