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CompletedNCT07106242Updated Mar 19, 2026Results posted

Adaptive Deep Brain Stimulation (aDBS) Study (Early Adapter) Part II

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

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the detailed description

Prospective randomized, single-blind, crossover, multicenter study of aDBS in subjects with Parkinson's disease.

02

Conditions studied

  • Parkinson Disease

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03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    aDBS Preferred Mode

    Device: Adaptive DBS

  • Active comparator
    cDBS

    Device: cDBS

Interventions

  • DeviceAdaptive DBS

    Subjects will receive Dual or Single Threshold aDBS which are acceptable

  • DevicecDBS

    cDBS

05

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

06

Results

Posted Mar 19, 2026
Limitations and caveats
We hypothesize that a period effect or carryover effect may be present in this cross-over design study, which could impact the ability to compare aDBS and cDBS for the primary endpoint. Therefore, exploratory analyses would be conducted to evaluate TEED between study arms to further investigate potential differences if either one is present.

Participant flow

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).

First Intervention
Participant flow — First Intervention
MilestoneaDBS -> cDBScDBS -> aDBS
Started1411
Completed1411
Not completed00
Second Intervention
Participant flow — Second Intervention
MilestoneaDBS -> cDBScDBS -> aDBS
Started1411
Completed1411
Not completed00

Outcome measures

PrimaryTotal 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.
Reported as:
Mean · μWatts
Total Electrical Energy Delivered (TEED) During Adaptive (aDBS) as Compared to Continuous DBS (cDBS)
μWattsaDBScDBS
Visit 2 (The average value for the last 14 days of Visit2)109.7 ± 69.16116.8 ± 55.36
Visit 3 (The average value for the last 14 days of Visit3)119.6 ± 52.05119.7 ± 75.78
SecondaryThe 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
Reported as:
Mean · percentage of time
The Mean Percent Time Within an Optimal Beta LFP Threshold of Beta LFP Power During aDBS Mode Compared to cDBS.
percentage of timeaDBScDBS
The Mean Percent Time Within an Optimal Beta LFP Threshold of Beta LFP Power During aDBS Mode Compared to cDBS.36.3 ± 21.7634.4 ± 23.53

Adverse events

Collected over From enrollment until study completion, up to 10 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
aDBS0/25 (0%)0/25 (0%)0/25 (0%)
cDBS0/25 (0%)0/25 (0%)0/25 (0%)

Baseline characteristics

A total of 25 patients enrolled for the study were summarized.

Age, Continuous
Age, Continuous(years)Total
Mean70.0 ± 7.50
Sex: Female, Male
Sex: Female, Male(Participants)Total
Female14
Male11
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Total
Region of Enrollment
Region of Enrollment(participants)Total
Japan25
PD Duration
PD Duration(years)Total
Mean12.1 ± 4.57
07

Study locations

2 sites
  • Juntendo University Nerima Hospital
    Tokyo, Nerima-ku 177-8521, Japan
  • Juntendo University Hospital
    Bunkyo-ku, Tokyo 113-0033, Japan
08

References and documents

Study documents

  • Study protocol · Oct 31, 2022
  • Statistical analysis plan · May 12, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT07106242
Lead sponsor
MedtronicNeuro
Responsible party
Sponsor
First posted
Aug 6, 2025
Start date
Nov 29, 2021
Primary completion
May 8, 2023
Completion
Oct 23, 2023
Results posted
Mar 19, 2026
Last update
Mar 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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