Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study
ConditionParkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedtronicNeuro
About this trial
The purpose of the study is to evaluate the effectiveness of the Medtronic Adaptive DBS therapy (aDBS) for Parkinson's Disease in China with the Percept family of Implantable Neurostimulators (Percept PC and Percept RC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects must meet all general inclusion/
Disqualifiers
Subjects must meet the LFP screening inclusion criterion (as assessed at the LFP Screening Visit)
Subject has idiopathic Parkinson's disease
Subject is implanted (>3 months prior to enrollment for new INS implants or >1 month from INS replacement) with a Percept PC (Model B35200) or Percept RC (Model B35300) and Medtronic DBS leads (Model 3387, 3389, B33005 or B33015) and extensions (Model 37086 or B34000) bilaterally in the same target (physician confirmed), STN or GPi
In the opinion of the investigator, the subject responds to DBS Therapy.
Trial design
Design model
Single group
Treatments tested in this trial
Percept™ PC and Percept RC with Adaptive DBS (aDBS™)
DeviceSubjects for whom meet the LFP screening criteria and can be acceptably configured on the "Best" aDBS mode (Dual or Single Threshold) will receive "Best" Mode aDBS treatment and enter the aDBS Evaluation Phase.
Treatment groups
62 Participants
are divided into 1 treatment groupGroup A: Single-arm who received aDBS "Best" Mode (Dual or Single Threshold )Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
"On" time without troublesome dyskinesia (i.e. Good "On" Time)
Proportion of aDBS subjects meet a success criterion relative to stable cDBS.The success criterion: no worse than 2 hours/day less of "On" time without troublesome dyskinesia (i.e. Good "On" Time) during aDBS compared to cDBS.
Time frame
From the cDBS baseline to aDBS evaulation phase at about 1 monthOther outcomes
1
Assess the Adverse Event among the Participants
To characterize: * Stimulation-related adverse events (AEs) * Adverse events including serious adverse events (SAEs) and device deficiencies
Time frame
From enrollment to the end of treatment at around 12 months to 17.5 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov