Japan Post Market Adaptive Deep Brain Stimulation (aDBS) Study (Early Adapter) Part I

Active, not recruiting

• Conditions: Parkinson's disease

• Registration Number: jRCT1042200088
• Lead Sponsor: Medtronic Japan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-25
• Study Start: 2021-07-03
• Last Update Posted: 2022-09-03

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Subject has Parkinson's disease with motor impairment
2. Subject is implanted with Percept PC (Model B35200) and Medtronic DBS leads (Model 3387 or 3389) and extensions (Model 37086) 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 and expected to remain stable from enrollment through the end of the aDBS Adjustment 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
7. Subject 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 childbearing potential, and if sexually active, must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator

9. Subject has Beta band (8-30 Hz) amplitude >= 1.2 micro Vp detected on either left and/or right DBS leads on sensing channels 0-2, 0-3, or 1-3; 8-10, 8-11, or 9-11
   

Exclusion Criteria

1. Subject and/or caregiver is unable to utilize the patient programmer
2. Subject has more than one INS
3. At enrollment, the subject's INS has a predicted battery life of <1 year
4. In the opinion of the investigator, subject has untreated severe depression which may preclude them from study participation
5. Subject requires diathermy, transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or Magnetic resonance-guided focused ultrasound (MRgFUS)
6. Subject has a metallic implant in the head, (eg, aneurysm clip, cochlear implant)
7. Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (eg, cardiac pacemaker, defibrillator, spinal cord stimulator)
8. Subject has, or plans to obtain, an implanted medication pump for the treatment of Parkinson's disease (eg, DUOPATM infusion pump) and/or portable infusion pump
9. Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation
10. Subject is breast feeding
11. Subject is under the age of 20 years
12. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study as confirmed by the Medtronic study team
13. Subjects with signal artifact on all 6 aDBS sense pathways (3 each on both DBS leads)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of subjects		To characterize the proportion of subjects for whom at least one of two aDBS modes (single and dual threshold) is acceptable to the subject.

Secondary Outcome Measures

Name	Time	Method
aDBS mode acceptability		To identify baseline factors predicting aDBS mode acceptability (single or dual threshold). Candidates factors include, but are not limited to: Age, years with PD, PD phenotype, and Levodopa Equivalent Daily Dose (LEDD) at study entry.
Parkinson's Disease Questionnaire (PDQ)-39 Summary Index (SI) and subscores		To characterize clinical outcomes of the preferred aDBS mode as compared to cDBS Baseline. Subscores include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, bodily discomfort.
EQ-5D-5L		To characterize clinical outcomes of the preferred aDBS mode as compared to cDBS Baseline.
PDQ-39 speech questions 34 and 35		To characterize clinical outcomes of the preferred aDBS mode as compared to cDBS Baseline.
Unified Dyskinesia Rating Scale (UDysRS)		To characterize clinical outcomes of the preferred aDBS mode as compared to cDBS Baseline.
Movement Disorder Society-Sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III		To characterize clinical outcomes of the preferred aDBS mode as compared to cDBS Baseline.
Movement data collected from Apple Watch		To characterize clinical outcomes of the preferred aDBS mode as compared to cDBS Baseline.
Patient preference of aDBS by mode question		To characterize clinical outcomes of the preferred aDBS mode as compared to cDBS Baseline.
Correlation of Percept Device data with movement data and clinical outcomes		To assess the potential correlation of Percept Device data with movement data collected from Apple Watch and clinical outcomes.