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 (part of Medtronic) · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 3 years 7 months after the study started (first participant enrolled Nov 2021, registered Jul 2025).

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

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.

Conditions studied

Parkinson Disease

Browse trials for

Parkinson Disease 4,573

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's enrollment of 25 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

MedtronicNeuro is the lead sponsor of 74 studies on the registry; 2 are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Browse MedtronicNeuro studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.)
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 for participation in the study prior to the study-related procedures being conducted.
Subject is a male or non-pregnant female. If female of , and if sexually active, must be using, or agree to use, a medically acceptable method of as confirmed by the investigator.

Exclusion criteria

Exclusion Criteria:

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.
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

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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

What researchers measure

Primary outcomes

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

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

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
Milestone	aDBS -> cDBS	cDBS -> aDBS
Started	14	11
Completed	14	11
Not completed	0	0

Second Intervention

Participant flow — Second Intervention
Milestone	aDBS -> cDBS	cDBS -> aDBS
Started	14	11
Completed	14	11
Not completed	0	0

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)
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

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 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

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
Group	Deaths	Serious	Other
aDBS	0/25 (0%)	0/25 (0%)	0/25 (0%)
cDBS	0/25 (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
Mean	70.0 ± 7.50

Sex: Female, Male
Sex: Female, Male(Participants)	Total
Female	14
Male	11

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Total

Region of Enrollment
Region of Enrollment(participants)	Total
Japan	25

PD Duration
PD Duration(years)	Total
Mean	12.1 ± 4.57

Study locations

2 sites

Juntendo University Nerima Hospital
Tokyo, Nerima-ku 177-8521, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo 113-0033, Japan

References and documents

Study documents

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

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in May 2023, 17 months.

Results were first posted in Mar 2026, 2 years 10 months after primary completion.

Of 76 industry-sponsored interventional studies with no phase under Parkinson Disease, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 43. This study's 17 months is below that.

Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 9, 2025
First posted: Aug 6, 2025
StartActual: Nov 29, 2021
Primary completionActual: May 8, 2023
CompletionActual: Oct 23, 2023
Results first posted: Mar 19, 2026
Last update: Mar 19, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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