Adaptive Deep Brain Stimulation (aDBS) Study (Early Adapter) Part II

Sponsor
MedtronicNeuro
Study ID
NCT07106242
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Adaptive DBS — DEVICE
    Subjects will receive Dual or Single Threshold aDBS which are acceptable
  • cDBS — DEVICE
    cDBS

Study Details

The purpose of the study is to evaluate the efficacy of aDBS (preferred mode, single or dual threshold) vs standard continuous DBS (cDBS) in decreasing Total Electrical Energy Delivered (TEED). Prospective randomized, single-blind, crossover, multicenter study of aDBS in subjects with Parkinson's disease.

Key Dates

Start date
Nov 29, 2021
Status verified
Mar 2026
Primary completion
May 8, 2023
Completion
Oct 23, 2023

Study Design

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

Arms

  • Experimental: aDBS Preferred Mode
  • Active Comparator: cDBS

Primary Outcome Measure

Total Electrical Energy Delivered (TEED) During Adaptive (aDBS) as Compared to Continuous DBS (cDBS) [ Time Frame: First 45-day period after the randomization with aDBS or cDBS treatment as randomized, will be compared to the following second 45-day period of aDBS or cDBS treatment. ]

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