Parkinson Disease
Conditions
Brief summary
The purpose of the study is to evaluate the efficacy of aDBS (preferred mode, single or dual threshold) vs standard continuous DBS (cDBS) in decreasing Total Electrical Energy Delivered (TEED). Prospective randomized, single-blind, crossover, multicenter study of aDBS in subjects with Parkinson's disease.
Detailed description
Prospective randomized, single-blind, crossover, multicenter study of aDBS in subjects with Parkinson's disease.
Interventions
DEVICEAdaptive DBS
Subjects will receive Dual or Single Threshold aDBS which are acceptable
DEVICEcDBS
cDBS
Sponsors
MedtronicNeuro
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has Parkinson's disease with motor impairments. 2. Subject is implanted with Percept PC and Medtronic DBS leads and extensions bilaterally in the same target (physician confirmed), STN or GPi. 3. Subject has completed Early Adapter 1 study OR if the subject has not completed Early Adapter 1, she/he has documented evidence that aDBS is well tolerated in at least one mode (single or dual threshold) (Note: Tolerance means that the investigator has determined that aDBS is suitable for PD treatment). For subject who only tolerated dual threshold mode, aDBS must be set up in both hemispheres. 4. Subject has 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, or 1-3; 8-10, 8-11, or 9-11; As assessed in screening from Early Adapter I study. For subjects who have not completed Early Adapter Part I, it can be assessed using the record of standard test of eligibility for aDBS at the site. 5. The subject responds to DBS Therapy. 6. The subject's cDBS parameters and PD medications are stable and expected to remain stable from enrollment through the end of the aDBS treatment phase. (Note: Stability is defined as no major changes in cDBS parameter and medication for the last 30 days prior to aDBS setup or as defined by the physician.) 7. Subject is configured to monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) on at least one side 8. Subject is willing and able to attend all study-required visits and complete the study procedures. 9. Subject has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted. 10. 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.
Exclusion criteria
1. Subject and/or caregiver is unable to utilize the patient programmer. 2. Subject has more than one lead in each hemisphere of the brain. 3. Subject has cortical leads or additional unapproved hardware implanted in the brain. 4. Subject has more than one INS. 5. No tested mode of aDBS (single or dual threshold) is tolerated. (Note: Tolerance is defined that investigator has determined that aDBS is suitable for PD treatment.). 6. At enrollment, the subject's INS has a predicted battery life of \<1 year. 7. Subject has untreated severe depression which may preclude them from study participation. 8. Subject requires diathermy, transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or Magnetic resonance-guided focused ultrasound (MRgFUS). 9. Subject has a metallic implant in the head, (e.g., aneurysm clip, cochlear implant). 10. Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemaker, defibrillator, spinal cord stimulator). 11. Subject has, or plans to obtain, an implanted medication pump for the treatment of Parkinson's disease (e.g., CADD-Legacy1400 pump) and/or portable infusion pump. 12. The subject has an abnormal neurological examination that would preclude him from study participation. 13. Subject is breast feeding. 14. Subject is under the age of 20 years. 15. 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. 16. Subjects with signal artifact on all 6 aDBS sense pathways (3 on each of both DBS leads) which preclude the clinician from setting thresholds\* \*As assessed in aDBS setup from Early Adapter Part I and aDBS data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Electrical Energy Delivered (TEED) During Adaptive (aDBS) as Compared to Continuous DBS (cDBS) | First 45-day period after the randomization with aDBS or cDBS treatment as randomized, will be compared to the following second 45-day period of aDBS or cDBS treatment. | Comparison of TEED between aDBS and cDBS at aDBS treatment phase (Visit 2 and Visit 3). The TEED was computed using the average stimulation currents from the timeline data during the last 14 days at Visit 2 and Visit 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Percent Time Within an Optimal Beta LFP Threshold of Beta LFP Power During aDBS Mode Compared to cDBS. | A 45-day period of aDBS treatment will be compared to a 45-day period of cDBS treatment | The secondary objective is to demonstrate maintenance within an optimal beta LFP threshold of beta LFP power during aDBS mode compared to cDBS. The optimal beta LFP threshold indicates values between upper and lower LFP threshold preset for each patient. |
Countries
Japan
Participant flow
Recruitment details
First enrollment: November 29, 2021 Last patient last visit: October 23, 2023 The study was conducted at two sites located in Japan. Participants were either completed the Early Adapter I study, or they had undergone a standard assessment demonstrating their tolerability of aDBS (preferred mode).
Pre-assignment details
Randomization and Treatment Assignment 7 days or more after cDBS has been set and within 30 days after the baseline visit. 25 subjects were randomly assigned during a randomization to either sequence, the first intervention was aDBS then cDBS (aDBS -\> cDBS) or the first intervention was cDBS then aDBS (cDBS -\> aDBS).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 70.0 years STANDARD_DEVIATION 7.5 |
| PD Duration | 12.1 years STANDARD_DEVIATION 4.57 |
| Region of Enrollment Japan | 25 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
None listed