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

JRCT ID: jRCT1042200088

Registered date:25/12/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 03/07/2021
• Target sample size: 15
• Study type: Observational

Outcome(s)

• Primary Outcome: 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

- 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.
- To characterize clinical outcomes of the preferred aDBS mode as compared to cDBS Baseline:
- EQ-5D-5L
- Parkinson's Disease Questionnaire (PDQ)-39 Summary Index (SI) and subscores: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, bodily discomfort
- PDQ-39 speech questions 34 and 35
- Unified Dyskinesia Rating Scale (UDysRS)
- Movement Disorder Society-Sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III
- Movement data collected from Apple Watch
- Patient preference of aDBS by mode question To assess the potential correlation of Percept Device data with movement data collected from Apple Watch and clinical outcomes

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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)

Related Information

• Primary Sponsor: Sekiguchi Yuta