Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Parkinson Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Experimental arm (VERUM): delivery of an active medical device for a period of 2 months. Then delivery of a second active medical device for a period of 4 months. Control arm (SHAM): delivery of an inactive medical device for a period of 2 months of use then delivery of an active medical device from M2 to M6 after inclusion.Masking: Triple (Participant, Care Provider, Investigator)Masking Description: ratio 1 :1 in each centre on an online randomization modulePrimary Purpose: Other

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Intervention 1 Name : VERUM Description : Experimental arm (VERUM): delivery of an active medical device for a period of 2 months. Then delivery of a second active medical device for a period of 4 months. Intervention 2 Name : SHAM Description: Control arm (SHAM): delivery of an inactive medical dev...

Intervention 1 Name : VERUM Description : Experimental arm (VERUM): delivery of an active medical device for a period of 2 months. Then delivery of a second active medical device for a period of 4 months. Intervention 2 Name : SHAM Description: Control arm (SHAM): delivery of an inactive medical device for a period of 2 months of use then delivery of an active medical device from M2 to M6 after inclusion

Tracking Information

NCT #
NCT04648150
Collaborators
Remedee Labs SAS
Investigators
Not Provided