An interventional study of Adaptive DBS and cDBS in Parkinson Disease, sponsored by MedtronicNeuro. Completed at 2 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by MedtronicNeuro · Not applicable, Interventional, and Treatment
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.
Prospective randomized, single-blind, crossover, multicenter study of aDBS in subjects with Parkinson's disease.
Exclusion Criteria:
Device: Adaptive DBS
Device: cDBS
Subjects will receive Dual or Single Threshold aDBS which are acceptable
cDBS
Total Electrical Energy Delivered (TEED) During Adaptive (aDBS) as Compared to Continuous DBS (cDBS)
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.
Time frame: 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.
The Mean Percent Time Within an Optimal Beta LFP Threshold of Beta LFP Power During aDBS Mode Compared to cDBS.
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.
Time frame: A 45-day period of aDBS treatment will be compared to a 45-day period of cDBS treatment
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).
| Milestone | aDBS -> cDBS | cDBS -> aDBS |
|---|---|---|
| Started | 14 | 11 |
| Completed | 14 | 11 |
| Not completed | 0 | 0 |
| Milestone | aDBS -> cDBS | cDBS -> aDBS |
|---|---|---|
| Started | 14 | 11 |
| Completed | 14 | 11 |
| Not completed | 0 | 0 |
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.
| μWatts | aDBS | cDBS |
|---|---|---|
| Visit 2 (The average value for the last 14 days of Visit2) | 109.7 ± 69.16 | 116.8 ± 55.36 |
| Visit 3 (The average value for the last 14 days of Visit3) | 119.6 ± 52.05 | 119.7 ± 75.78 |
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.
| percentage of time | aDBS | cDBS |
|---|---|---|
| The Mean Percent Time Within an Optimal Beta LFP Threshold of Beta LFP Power During aDBS Mode Compared to cDBS. | 36.3 ± 21.76 | 34.4 ± 23.53 |
Collected over From enrollment until study completion, up to 10 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| aDBS | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| cDBS | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
A total of 25 patients enrolled for the study were summarized.
| Age, Continuous(years) | Total |
|---|---|
| Mean | 70.0 ± 7.50 |
| Sex: Female, Male(Participants) | Total |
|---|---|
| Female | 14 |
| Male | 11 |
| Race and Ethnicity Not Collected(Participants) | Total |
|---|
| Region of Enrollment(participants) | Total |
|---|---|
| Japan | 25 |
| PD Duration(years) | Total |
|---|---|
| Mean | 12.1 ± 4.57 |
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MedtronicNeuro