Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Adaptive DBS

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 25B
      • Toronto Western Hospital
• France
  • Grenoble, France
    • UJF Grenoble
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam UMC, location AMC
• United States
  • California
    • San Francisco, California, United States, 94115
      • University of California San Francisco
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

General

1. Subject has idiopathic Parkinson's disease
2. Subject is implanted with Percept PC (Model B35200) and Medtronic DBS leads (Model 3387, 3389, B33005 or B33015) and extensions (Model 37085, 37086, or B34000) bilaterally in the same target (physician confirmed), STN or 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.

5. (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)

LFP Screening Inclusion Criteria

1. Subject has required 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aDBS Single Threshold; Adaptive DBS Single Threshold Mode	Device: Adaptive DBS; Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS; Other Names: aDBS
Experimental: aDBS Dual Threshold; Adaptive DBS DualThreshold Mode	Device: Adaptive DBS; Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS; Other Names: aDBS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (Stimulation-related AEs)	To characterize stimulation-related adverse events	Up to 45 days per mode (average of 30 days)
Safety (SAEs, AEs and DDs)	To characterize serious adverse events, adverse events and device deficiencies	Through study completion, approximately 1.5 years

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Principal Investigator: Helen Bronte-Stewart, MD, MSE, Stanford University

Publications and helpful links

General Publications

• Swinnen BEKS, Buijink AW, Pina-Fuentes D, de Bie RMA, Beudel M. Diving into the subcortex: The potential of chronic subcortical sensing for unravelling basal ganglia function and optimization of deep brain stimulation. Neuroimage. 2022 Jul 1;254:119147. doi: 10.1016/j.neuroimage.2022.119147. Epub 2022 Mar 27.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): January 12, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Deep Brain Stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: MDT19001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes