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

NCT05753449 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-05-28

Study results available
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Summary

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.

Conditions

  • Parkinson Disease
  • Deep Brain Stimulation

Interventions

DEVICE

Baseline (or standard of care) DBS programming

Baseline (or standard of care) DBS programming.

DEVICE

Burst-type DBS electrical stimulation programming

Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY
  • Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

    lead OTHER

Principal Investigators

  • Nestor Tomycz · Allegheny Health Network AGH Department of Neuroscience

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-24
Primary Completion
2024-02-21
Completion
2024-02-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05753449 on ClinicalTrials.gov