Clinical trial NCT04547712: Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease
Official title: Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Parkinson's Disease
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2020-09-14
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomization to a crossover sequence of aDBS single threshold and aDBS dual threshold modes
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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)

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

Primary outcomes:
measure: On time without troublesome dyskinesia
timeFrame: Change from Baseline at 1 and 2 months post-randomization
Secondary outcomes:
measure: Stimulation energy use
timeFrame: Change from Baseline at 1 and 2 months post-randomization
Other outcomes:
measure: Safety (Stimulation-related AEs)
timeFrame: Up to 45 days per mode (average of 30 days)
measure: Safety (SAEs, AEs and DDs)
timeFrame: Through study completion, approximately 1.5 years
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Grenoble
country: France
facility: UJF Grenoble
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
Study officials:
affiliation: Stanford University
name: Helen Bronte-Stewart, MD, MSE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.