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

NCT07106242 | Completed Results FDA Device

• 1 other identifier: MDT20041
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

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.

  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.

  A 45-day period of aDBS treatment will be compared to a 45-day period of cDBS treatment

Study Arms (2)

aDBS Preferred Mode

EXPERIMENTAL

Device: Adaptive DBS

cDBS

ACTIVE COMPARATOR

Device: cDBS

Interventions

Adaptive DBS DEVICE

Subjects will receive Dual or Single Threshold aDBS which are acceptable

aDBS Preferred Mode

cDBS DEVICE

cDBS

cDBS

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (2)

Juntendo University Nerima Hospital

Tokyo, Nerima-ku, 177-8521, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-0033, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

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.

Results Point of Contact

• Title: Clinical Scientist
• Organization: Medtronic

yuta.sekiguchi@medtronic.com

+818072283557

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 6, 2025
• Study Start: November 29, 2021
• Primary Completion: May 8, 2023
• Study Completion: October 23, 2023
• Last Updated: March 19, 2026
• Results First Posted: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)