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DBS Imaging-based vs. Threshold Assessment-based Programming

NCT06223399 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2024-01-25

No results posted yet for this study

Summary

The goal of this single-center prospective, randomized, open-label clinical trial is to compare the effectiveness of imaging-based DBS programming with threshold assessment-based DBS programming in patients with Parkinson's disease and motor response fluctuations.

The main question the study aims to answer is:

Is the improvement of motor symptoms in the OFF-drug phase following STN DBS for Parkinson's disease, using imaging-based DBS programming only, non-inferior to the improvement of motor symptoms following DBS programming with threshold assessment at six months follow-up?

Participants will be randomized to imaging-based programming or to threshold assessment-based programming. The main clinical outcome is motor symptoms; secondary outcomes are level of physical disability and quality of life, among others.

Conditions

  • Deep Brain Stimulation
  • Parkinson Disease
  • Imaging

Interventions

OTHER

Imaging-based programming

Preferred contact point(s) and settings for DBS programming will be determined based on the visualization of the electrodes in the patient-specific anatomy and the volume of tissue activated (VTA; i.e., the tissue enclosed within an iso-surface of the activation function). This will be determined with help of the software program Brainlab with the GUIDE XT module.

OTHER

Threshold assessment-based programming

The preferred contact point(s) and settings for DBS programming will be determined according to current clinical practice. During the threshold assessment, the amount of electrical current needed to generate symptomatic improvement and the amount of electrical current needed to generate adverse-effects are determined for every contact point of both DBS leads by increasing current with 0.5 mA steps from 0 to approximately 5.0 mA. With each step, severity of Parkinson symptoms and presence of possible adverse-effects are assessed. For each side (i.e., left and right), the contact point with the most favorable trade-off between clinical improvement and adverse effects will be used for stimulation.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Rob de Bie, Prof · Amsterdam UMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-03
Primary Completion
2025-12-15
Completion
2026-03-15

Countries

  • Netherlands

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 NCT06223399 on ClinicalTrials.gov