Smarter brain stimulator could save battery life in Parkinson's patients

NCT ID NCT07106242

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new type of deep brain stimulation (DBS) called adaptive DBS (aDBS) in 25 people with Parkinson's disease. Unlike standard continuous DBS, aDBS adjusts stimulation in real time based on brain signals. The goal was to see if aDBS uses less total electrical energy while still controlling symptoms. Participants were already implanted with a compatible DBS system and had previously tolerated aDBS. The study compared energy use between aDBS and standard DBS over two weeks each.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
adaptive deep brain stimulation (aDBS) device
What this could lead to
If successful, this could lead to more efficient, longer-lasting deep brain stimulation for Parkinson's, potentially reducing battery changes and side effects.
What could go wrong
This is a small, completed study (25 people) focused on energy use, not direct symptom improvement. Results may not apply to all Parkinson's patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

25 people

The number who actually took part.

Started

Nov 2021

Finished

Oct 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Parkinson disease are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-0033, Japan

  • Juntendo University Nerima Hospital

    Tokyo, Nerima-ku, 177-8521, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.