NCT05910008

Brief Summary

During deep brain stimulation procedures in Parkinson's disease (PD), the most important prognostic element is the positioning of the surgical electrode in the subthalamic nucleus which is the anatomical target. The main objective of this project is therefore to compare 2 techniques thanks to a prospective comparative randomised open-label study: the use of O-ARM to acquire stereotactic imaging directly in the operating room and the standard technique requiring stereotactic imaging to be performed in the radiology department.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

February 5, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2026

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

June 8, 2023

Last Update Submit

May 6, 2026

Conditions

Parkinson Disease

Keywords

Stereotactic imagingDeep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

  • The absolute accuracy of Deep Brain Stimulation electrode implantation

    The radial distance between the theoretical target and the electrode in the plane of the target regardless of the chosen trajectory (central, anterior, lateral). This distance corresponds to the minimum error between the target and the electrode. This measurement is made from the postoperative brain scan.

    48 hours

Secondary Outcomes (7)

  • The anatomical accuracy of Deep Brain Stimulation electrode implantation

    48 hours

  • Central and alternate position of the electrodes rate

    1 day

  • Surgical Times

    1 day

  • Clinical effectiveness

    6 months

  • Daily dose of Levodopa decrease

    6 months

  • +2 more secondary outcomes

Study Arms (2)

O-Arm stereotactic imaging

EXPERIMENTAL

Imaging is performing directly in the operating room.

Procedure: O-Arm Stereotactic imaging

Standard stereotactic imaging

ACTIVE COMPARATOR

Imaging is performing in Radiology department.

Procedure: Standard Stereotactic imaging

Interventions

O-Arm Stereotactic imagingPROCEDURE

Prior to electrode implantation, O-ARm stereotactic imaging (Magnetic Resonance Imaging)

O-Arm stereotactic imaging
Standard Stereotactic imagingPROCEDURE

Prior to electrode implantation, standard stereotactic imaging (Magnetic Resonance Imaging)

Standard stereotactic imaging

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of idiopathic Parkinson's disease at the stage of motor fluctuations despite optimal medical treatment
  • Indication for Deep Brain Stimulation (DBS) of the subthalamic nucleus approved by the local multidisciplinary deep brain stimulation committee after an operability assessment (see Appendix)
  • Informed and signed patient consent
  • Affiliation to a social security scheme

You may not qualify if:

  • Significant cognitive decline assessed in a dedicated multidisciplinary consultation
  • Contraindication to Magnetic Resonance Imaging (MRI)
  • Presence of pathologies contraindicating deep brain stimulation
  • No contraceptive treatment for women of childbearing age
  • Pregnant or breastfeeding woman
  • Anticoagulant or antiaggregant treatment that cannot be stopped
  • Persons under legal protection (persons deprived of liberty or incapable of giving consent or under guardianship or tutelage...)
  • Patient with severe psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Amaury De Barros, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2023

First Posted

June 18, 2023

Study Start

February 5, 2024

Primary Completion

June 16, 2025

Study Completion

January 14, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Locations

FR(1)