6
Participants
Start Date
June 1, 2017
Primary Completion Date
December 30, 2018
Study Completion Date
December 30, 2018
adaptive Deep Brain Stimulation
"The investigational medical device (AlphaDBSvext) is a portable, external, dual mode stimulator that can deliver adaptive DBS or conventional DBS for the treatment of PD.~In the adaptive mode, the device records Local Field Potential activity from the implanted DBS electrode and simultaneously delivers stimulation through the same electrode based on the recorded signal."
conventional Deep Brain Stimulation
"The same investigational medical device (AlphaDBSvext) is used to deliver conventional DBS for the treatment of PD. In the conventional mode it delivers constant stimulation."
Centro Parkinson e Disturbi del Movimento ASST G.Pini- CTO, Milan
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico, Milan
IRCCS Istituto Ortopedico Galeazzi, Milan
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, Pavia
Lead Sponsor
Newronika
INDUSTRY