Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease

Part of paid clinical trials in San Francisco, California.

Sponsor
MedtronicNeuro
Study ID
NCT04547712
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Dec 14, 2020
Status verified
Jul 2025
Primary completion
Jan 12, 2023
Completion
May 2, 2025

Study Design

Enrollment
85 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: aDBS Single Threshold
    Adaptive DBS Single Threshold Mode
  • Experimental: aDBS Dual Threshold
    Adaptive DBS Dual Threshold Mode

Primary Outcome Measure

Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold. [ Time Frame: About one month ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94115-
Stanford University Medical CenterStanfordCalifornia94305-
University of FloridaGainesvilleFlorida32608-
Massachusetts General HospitalBostonMassachusetts02114-
Duke UniversityDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
Vanderbilt University Medical CenterNashvilleTennessee37232-

Find similar trials in San Francisco, CA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of California San Francisco· San Francisco, CAStanford University Medical Center· Stanford, CAUniversity of Florida· Gainesville, FLMassachusetts General Hospital· Boston, MADuke University· Durham, NCCleveland Clinic· Cleveland, OH

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