Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease

Parkinson Disease Clinical Trial

— ADAPT-PD  

Official title:

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04547712
• Other study ID #: MDT19001
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 85
• Est. completion date: December 2024
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Adaptive DBS
Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario
France	UJF Grenoble	Grenoble
Netherlands	Amsterdam UMC, location AMC	Amsterdam
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of California San Francisco	San Francisco	California
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

United States,  Canada,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety (Stimulation-related AEs)	To characterize stimulation-related adverse events	Up to 45 days per mode (average of 30 days)
Other	Safety (SAEs, AEs and DDs)	To characterize serious adverse events, adverse events and device deficiencies	Through study completion, approximately 1.5 years
Primary	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	Stimulation energy use	Total electrical energy delivered (TEED) for aDBS as compared with cDBS.	Change from Baseline at 1 and 2 months post-randomization