Parkinson DiseaseNCT07106242
Adaptive Deep Brain Stimulation (aDBS) Study (Early Adapter) Part II
A study testing Adaptive DBS and cDBS in people with Parkinson Disease, run by MedtronicNeuro at 2 sites in Japan.
Trial 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 more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Adaptive DBS and cDBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesJapan
- Study dates
- 29 Nov 2021to 23 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has Parkinson's disease with motor impairments.
- Subject is implanted with Percept PC and Medtronic DBS leads and extensions bilaterally in the same target (physician confirmed), STN or GPi.
- 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.
- 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.
- The subject responds to DBS Therapy.
- 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.)
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- Subject is configured to monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) on at least one side
- Subject is willing and able to attend all study-required visits and complete the study procedures.
- Subject has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted.
- 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.
Who cannot join
- Subject and/or caregiver is unable to utilize the patient programmer.
- Subject has more than one lead in each hemisphere of the brain.
- Subject has cortical leads or additional unapproved hardware implanted in the brain.
- Subject has more than one INS.
- 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.).
- At enrollment, the subject's INS has a predicted battery life of <1 year.
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- Subject has untreated severe depression which may preclude them from study participation.
- Subject requires diathermy, transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or Magnetic resonance-guided focused ultrasound (MRgFUS).
- Subject has a metallic implant in the head, (e.g., aneurysm clip, cochlear implant).
- Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemaker, defibrillator, spinal cord stimulator).
- 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.
- The subject has an abnormal neurological examination that would preclude him from study participation.
- Subject is breast feeding.
- Subject is under the age of 20 years.
- 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.
- 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
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-0033
Juntendo University Nerima Hospital
Tokyo, Nerima-ku, 177-8521
About this study
Official title: Japan Post Market Adaptive Deep Brain Stimulation (aDBS) Study (Early Adapter) Part II
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.
- Conditions
- Parkinson Disease
- Being tested
- Adaptive DBS, cDBS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive DBSDevice
Subjects will receive Dual or Single Threshold aDBS which are acceptable
cDBSDevice
cDBS
| Study group | Role | What they receive |
|---|---|---|
| aDBS Preferred Mode | Experimental | Not described Receives: Device: Adaptive DBS |
| cDBS | Active comparator | Not described Receives: Device: cDBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: A 45-day period of aDBS treatment will be compared to a 45-day period of cDBS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start29 Nov 2021
- Primary completion8 May 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106242
- Sponsor's protocol ID
- MDT20041
- Status last verified
- Mar 2026
- First submitted
- 9 Jul 2025
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Japan Post Market Adaptive Deep Brain Stimulation (aDBS) Study (Early Adapter) Part II
- ClinicalTrials.gov ID
- NCT07106242
- Acronym / sponsor ID
- MDT20041
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 6 Aug 2025 (actual)
- Results
- Posted 19 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aDBS Preferred Mode | Experimental | Device: Adaptive DBS |
| cDBS | Active comparator | Device: cDBS |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has Parkinson's disease with motor impairments.
- Subject is implanted with Percept PC and Medtronic DBS leads and extensions bilaterally in the same target (physician confirmed), STN or GPi.
- 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.
- 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.
- The subject responds to DBS Therapy.
Key exclusion criteria (16 listed)
- Subject and/or caregiver is unable to utilize the patient programmer.
- Subject has more than one lead in each hemisphere of the brain.
- Subject has cortical leads or additional unapproved hardware implanted in the brain.
- Subject has more than one INS.
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive DBSSubjects will receive Dual or Single Threshold aDBS which are acceptable | Device | aDBS Preferred Mode |
| cDBScDBS | Device | cDBS |
Primary outcome
Total Electrical Energy Delivered (TEED) During Adaptive (aDBS) as Compared to Continuous DBS (cDBS)
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.
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.
1 secondary outcome
The Mean Percent Time Within an Optimal Beta LFP Threshold of Beta LFP Power During aDBS Mode Compared to cDBS.
Time frame: A 45-day period of aDBS treatment will be compared to a 45-day period of cDBS treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive DBS and cDBS in people with Parkinson Disease, run by MedtronicNeuro at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Electrical Energy Delivered (TEED) During Adaptive (aDBS) as Compared to Continuous DBS (cDBS) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.