Smarter brain stimulator could save battery life in Parkinson's patients
NCT ID NCT07106242
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
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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
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25 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Oct 2023
- Lead sponsor
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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
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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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
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Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-0033, Japan
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Juntendo University Nerima Hospital
Tokyo, Nerima-ku, 177-8521, Japan
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