Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease

NATerminatedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

June 1, 2017

Primary Completion Date

December 30, 2018

Study Completion Date

December 30, 2018

Conditions
Parkinson Disease
Interventions
DEVICE

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."

DEVICE

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."

Trial Locations (4)

Unknown

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Newronika

INDUSTRY

NCT03422757 - Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease | Biotech Hunter | Biotech Hunter