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

NCT05753449 | Terminated Results FDA Device

• 1 other identifier: 2022-234
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Baseline (Visit 1)

  This outcome is the Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Score in the "Medication Off" state, after the first treatment (administered for 30 minutes) and after the second treatment (administered for 30 minutes). For example, the first treatment for patients in the arm "Baseline Programming First, Then Experimental Burst-type Programming" was baseline (or standard of care) DBS programming, and the second treatment was experimental Burst-style programming. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108. A higher score indicates a worse outcome.

  Baseline

• Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Six Months (Visit 2)

  This outcomes is the Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Score in the "Medication Off" state and after burst-type DBS programming in the acute setting (after 30 minutes) at six months. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108. A higher score means a worse outcome. Note that the study arm titles refer to whether or not the patients were randomized to baseline programming or Burst-type programming at Visit 1. During this visit (Visit 2), all study subjects were to be evaluated in the medication-off state and then evaluated following 30 minutes of treatment with Burst-type programming. Treatment with baseline programming was not administered during this visit (Visit 2).

  6 months

• Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Twelve Months (Visit 3)

  This outcomes is the Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Score in the "Medication Off" state and after burst-type DBS programming in the acute setting (after 30 minutes) at 12 months. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108. A higher score means a worse outcome. Note that the study arm titles refer to whether or not the patients were randomized to baseline programming or Burst-type programming at Visit 1. During this visit (Visit 2), all study subjects were to be evaluated in the medication-off state and then evaluated following 30 minutes of treatment with Burst-type programming. Treatment with baseline programming was not administered during this visit (Visit 2).

  12 months

Study Arms (2)

Baseline Programming First, Then Experimental Burst-type Programming

EXPERIMENTAL

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.

Device: Baseline (or standard of care) DBS programming; Device: Burst-type DBS electrical stimulation programming

Experimental Burst-type Programming First, Then Baseline Programming

EXPERIMENTAL

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.

Device: Baseline (or standard of care) DBS programming; Device: Burst-type DBS electrical stimulation programming

Interventions

Baseline (or standard of care) DBS programming DEVICE

Baseline (or standard of care) DBS programming.

Also known as: Boston Scientific Neuromodulation (BSN) Vercise™ System

Baseline Programming First, Then Experimental Burst-type Programming; Experimental Burst-type Programming First, Then Baseline 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.

Also known as: Boston Scientific Neuromodulation (BSN) Vercise™ System

Baseline Programming First, Then Experimental Burst-type Programming; Experimental Burst-type Programming First, Then Baseline Programming

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral DBS-STN (subthalamic nucleus) target for idiopathic Parkinson's disease implanted minimum 6 months prior to the day of study enrollment
• Stable DBS programming settings and Parkinson's disease medications defined as no changes to either within past 2 weeks
• Comfortable using DBS controller to turn off device prior to study visits
• Able to provide informed consent and complete follow-up visits

You may not qualify if:

• DBS technology other than Boston scientific Genus/Gevia
• Unable to complete follow-up visits
• DBS brain targets other than STN (subthalamic nucleus)
• Signs of progressive cognitive decline

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

This study was terminated due to challenges in recruiting participants as reluctance of patients who have achieved successful outcomes with their DBS devices to participate. They are understandably hesitant to risk potential symptom worsening by altering their device settings, even for the purpose of research. One subject completed the trial and the second subject withdrew due to intolerance of the device settings. Both subjects were enrolled in the experimental arm of the trial.

Results Point of Contact

• Title: Megan Hendricks, regulatory Specialist
• Organization: Allegheny Health Network

megan.hendricks@ahn.org

412-330-6206

Study Officials

• Nestor Tomycz

  Allegheny Health Network AGH Department of Neuroscience

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects will be programmed to both settings over the course of the visits, but the order is randomized to ensure appropriate blinding of the UPDRS assessor. Unblinded examiner will then turn the DBS ON to the patient's baseline DBS settings continuously ON or to burst DBS mode. A blinded examiner who did not perform the programming change will perform a UPDRS-III evaluation
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon

Model Details: Randomized, double-blind cross-over study

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 3, 2023
• Study Start: August 24, 2022
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)