DBS Imaging-based vs. Threshold Assessment-based Programming

NCT06223399 | Recruiting DMC

• 1 other identifier: NL84601.018.23
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III in OFF phase

  The MDS-UPDRS III measures severity of Parkinson's disease. The scores range between 0 - 132, higher scores indicating worse motor symptoms.

  Change from baseline to 6 months of DBS.

Secondary Outcomes (12)

• MDS-UPDRS III in ON phase

  Change from baseline to 6 months of DBS.

• MDS-UPDRS IV

  Change from baseline to 6 months of DBS.

• MDS-UPDRS I

  Change from baseline to 6 months of DBS.

• MDS-UPDRS II in ON phase

  Change from baseline to 6 months of DBS.

• Academic Medical Center Linear Disability Score (ALDS)

  Change from baseline to 6 months of DBS.

Study Arms (2)

Imaging-based

EXPERIMENTAL

66 patients with Parkinson's disease will receive imaging-based DBS programming

Other: Imaging-based programming

Threshold assessment-based

ACTIVE COMPARATOR

66 patients with Parkinson's disease will receive DBS programming based on the threshold assessment

Other: Threshold assessment-based programming

Interventions

Imaging-based programming OTHER

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.

Imaging-based

Threshold assessment-based programming OTHER

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.

Threshold assessment-based

Eligibility Criteria

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

You may qualify if:

• Parkinson's disease diagnosis based on the clinical diagnostic criteria of Movement Disorder Society
• Scheduled for DBS screening
• Age of 18 years or older
• Understand the Dutch language

You may not qualify if:

• Legally incompetent adults
• No written informed consent
• Previous functional stereotactic neurosurgery
• Dementia
• Current depression or psychosis

Sponsors & Collaborators

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

Study Sites (1)

Amsterdam UMC location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

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

Study Officials

• Rob de Bie, Prof

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annabel van der Weide, MA

CONTACT

+31-20-5663943; a.vanderweide@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients cannot be blinded for the treatment allocation, because the person who programs the DBS receives either dictated stimulation parameters based on imaging or proceeds with care as usual with the threshold assessment. Blinded assessment of the primary outcome will be done by means of a physical examination blinded for randomization arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study will be a mono center prospective randomized open label blinded endpoint (PROBE) design trial comparing imaging-based DBS programming with DBS programming based on threshold assessment.

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 25, 2024
• Study Start: January 3, 2024
• Primary Completion: December 15, 2025
• Study Completion: March 15, 2026
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: It will be made available one year after the last study visit of the last participant
• Access Criteria: Upon request

Locations

NL (1)