Burst-Type Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study ID
NCT05753449
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Baseline (or standard of care) DBS programming — DEVICE
    Baseline (or standard of care) DBS programming.
  • Burst-type DBS electrical stimulation programming — DEVICE
    Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered.

Study Details

This is a study to evaluate Deep brain stimulation (DBS) burst-type electrical stimulation programming verses standard DBS programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered. Burst type DBS may improve the efficacy and durability of DBS pulse generator.

Key Dates

Start date
Aug 24, 2022
Status verified
May 2025
Primary completion
Feb 21, 2024
Completion
Feb 21, 2024

Study Design

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

Arms

  • Experimental: Baseline Programming First, Then Experimental Burst-type Programming
    In this arm, patients were randomized to initially receive treatment with baseline DBS programming (standard of care) at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then experimental Burst-type programming for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming.
  • Experimental: Experimental Burst-type Programming First, Then Baseline Programming
    In this arm, patients were randomized to initially receive treatment with experimental Burst-type DBS programming at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then baseline programming (standard of care) for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered.

Primary Outcome Measure

Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Baseline (Visit 1) [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
AHN Allegheny General HospitalPittsburghPennsylvania15212-

Find similar trials in Pittsburgh, PA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
AHN Allegheny General Hospital· Pittsburgh, PA

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