O-ARM Stereotactic Imaging in Deep Brain Stimulation for Parkinson's Disease

NCT ID: NCT05910008

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2025-06-15

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.

Detailed Description

Prior to electrode implantation we perform stereotactic imaging which requires the fixation of a stereotactic frame on the patient's head before imaging (Magnetic Resonance Imaging MRI / Computed Tomography CT). Currently, it is necessary to transfer the patient to the imaging department outside of the operating room after the stereotactic frame has been placed, for imaging (either MRI or CT) and then to return to the operating room to begin the electrode implantation procedure. Since 2016, the new generation O-Arm 2 allows the acquisition of stereotactic imaging with the stereotactic frame in place by increasing the field of view (40 cm versus 20 cm previously) directly in the operating room. As a result, the transfer step to the MRI and CT scanner preoperatively may no longer be necessary, and the procedure can be started more quickly with greater comfort and safety for the patient and the anaesthesia team. Several teams around the world have begun to use framed O-Arm as the gold standard for stereotactic imaging. However, no randomised controlled study has been performed to date comparing O-Arm stereotactic imaging with pre-operative CT and/or MRI reference imaging.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

O-Arm stereotactic imaging

Imaging is performing directly in the operating room.

Group Type: EXPERIMENTAL

O-Arm Stereotactic imaging

Intervention Type: PROCEDURE

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

Standard stereotactic imaging

Imaging is performing in Radiology department.

Group Type: ACTIVE_COMPARATOR

Standard Stereotactic imaging

Intervention Type: PROCEDURE

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

Interventions

O-Arm Stereotactic imaging

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

Intervention Type: PROCEDURE

Standard Stereotactic imaging

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amaury De Barros, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU de Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Amaury De Barros, MD

Role: CONTACT

debarros.a@chu-toulouse.fr

561779027 ext. +33

Facility Contacts

Amaury De Barros, MD

Role: primary

debarros.a@chu-toulouse.fr

561779027

Other Identifiers

2023-A00871-44

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/22/0489

Identifier Type: -

Identifier Source: org_study_id