Parkinson's Disease
Conditions
Keywords
Deep Brain Stimulation
Brief summary
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).
Detailed description
The ADAPT-PD China Study will utilize both Dual and Single Threshold aDBS modes (algorithms). Prospective, multicenter, open label comparison (with single-blind aDBS mode from aDBS randomization to evaluation phase), single arm clinical trial designed 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). The study is expected to be conducted at approximately 5 centers located in China.
Interventions
DEVICEPercept™ PC and Percept RC with Adaptive DBS (aDBS™)
Subjects 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.
Sponsors
MedtronicNeuro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must meet all general inclusion/
Exclusion criteria
(as assessed at the Enrollment Visit) 2. Subjects must meet the LFP screening inclusion criterion (as assessed at the LFP Screening Visit) General (Assessed at Enrollment Visit): 1. Subject has idiopathic Parkinson's disease 2. 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 3. In the opinion of the investigator, the subject responds to DBS Therapy. 4. Based on the opinion of the investigator, the subject's cDBS parameters and PD medications are stable (no changes within the last 4 weeks) and expected to remain stable from enrollment through the end of the aDBS Evaluation Phase 5. Subject is configured to monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) on at least one side 6. Subject is willing and able to attend all study-required visits and complete the study procedures (e.g. 1-month recall questionnaires, MDS-UPDRS III, Off stim/Off med visit) 7. Subject (or legally authorized representative) has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted 8. Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator LFP Screening Inclusion Criteria (Conducted during LFP Screening Visit): 1\. Subject has Alpha - Beta band (8-30 Hz) amplitude ≥ 1.2 μVp detected on either left and/or right DBS leads on sensing channels 0-2, 0-3, 1-3, 8-10, 8-11, or 9-11.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| "On" time without troublesome dyskinesia (i.e. Good "On" Time) | From the cDBS baseline to aDBS evaulation phase at about 1 month | 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. |
Countries
China
Contacts
STUDY_DIRECTORAlex Xie, Clinical Research&Medical Science Director
Medtronic (Shanghai) Management Co. Ltd.
Outcome results
None listed