Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease

Not Applicable

Active, not recruiting

• Conditions: Parkinson Disease
• Interventions: Device: Adaptive DBS

• Registration Number: NCT04547712
• Lead Sponsor: MedtronicNeuro

Brief Summary

The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson's disease.

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-09-10
• Study First Posted: 2020-09-14
• Study Start: 2020-12-14
• Primary Completion: 2023-01-12
• Disposition First Submitted: 2024-01-04
• Disposition First Posted: 2024-01-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-15
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

General

1. Subject has idiopathic Parkinson's disease

2. Subject is implanted with Percept PC (Model B35200) and Medtronic Deep Brain Stimulation (DBS) leads (Model 3387, 3389, B33005 or B33015) and extensions (Model 37085, 37086, or B34000) bilaterally in the same target (physician confirmed), subthalamic nucleus (STN) or Globus Pallidus (GPi)

3. In the opinion of the investigator, the subject responds to DBS Therapy.

4. Based on the opinion of the investigator, the subject's cDBS parameters and PD medications are stable and expected to remain stable from enrollment through the end of the aDBS Evaluation phase

5. (Primary Cohort) Subject is configured to ring mode monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) on at least one side.

6. (Directional Stimulation Cohort) Subject is configured to directional monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) 6. Subject is willing and able to attend all study-required visits and complete the study procedures (e.g. 1-month recall questionnaires, MDS-UPDRS III) 7. Subject has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted 8. Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator 9. For subjects with the SenSight system: Subject is configured to the following stimulation rates: 55, 85, 110, 125, 145, 164 or 180 Hz (as required for sensing/aDBS)

Local Field Potential (LFP) Screening Inclusion Criteria

1. Subject has required Alpha-Beta band (8-30 Hz) amplitude detected on either left and/or right DBS leads

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. At enrollment, the subject's INS has a predicted battery life of <1 year
6. Subject has Beck Depression Inventory II (BDI-II) > 25
7. Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
8. Subject has a metallic implant in the head, (eg, aneurysm clip, cochlear implant)
9. Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (eg, cardiac pacemaker, defibrillator, spinal cord stimulator)
10. Subject has, or plans to obtain, an implanted medication pump for the treatment of Parkinson's disease (eg, DUOPATM infusion pump) and/or portable infusion pump
11. Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation
12. Subject is breast feeding
13. Subject is under the age of 18 years
14. 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 as determined by the Medtronic study team
15. Subject is unable to use or tolerate wearable
16. Subjects with signal artifact on all 6 aDBS sense pathways (3 each on both DBS leads) which preclude the clinician from setting thresholds

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
aDBS Dual Threshold	Adaptive DBS	Adaptive DBS Dual Threshold Mode
aDBS Single Threshold	Adaptive DBS	Adaptive DBS Single Threshold Mode

Primary Outcome Measures

Name	Time	Method
On time without troublesome dyskinesia	Change from Baseline at 1 and 2 months post-randomization	Proportion of aDBS subjects with "On" time without troublesome dyskinesia exceeding the threshold (aDBS is no worse than one standard deviation less than cDBS).

Secondary Outcome Measures

Name	Time	Method
Stimulation energy use	Change from Baseline at 1 and 2 months post-randomization	Total electrical energy delivered (TEED) for aDBS as compared with cDBS.

Trial Locations

Locations (10)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

Amsterdam UMC, location AMC; 🇳🇱 Amsterdam, Netherlands

Duke University; 🇺🇸 Durham, North Carolina, United States

UJF Grenoble; 🇫🇷 Grenoble, France

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States