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

NCT ID: NCT07106242

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-29
• Study Completion Date: 2023-10-23

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.

Detailed Description

Prospective randomized, single-blind, crossover, multicenter study of aDBS in subjects with Parkinson's disease.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

aDBS Preferred Mode

Group Type: EXPERIMENTAL

Adaptive DBS

Intervention Type: DEVICE

Subjects will receive Dual or Single Threshold aDBS which are acceptable

cDBS

Group Type: ACTIVE_COMPARATOR

cDBS

Intervention Type: DEVICE

cDBS

Interventions

Adaptive DBS

Subjects will receive Dual or Single Threshold aDBS which are acceptable

Intervention Type: DEVICE

cDBS

cDBS

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedtronicNeuro

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Juntendo University Nerima Hospital

Tokyo, Nerima-ku, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

MDT20041

Identifier Type: -

Identifier Source: org_study_id