Asleep MRI-guided Versus Awake Microelectrode Recording Guided Deep Brain Stimulation in Parkinson's Disease: A Comparative Effectiveness Trial

NCT ID: NCT05453331

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 158 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2025-05-31

Brief Summary

Rationale: Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a well-accepted treatment for Parkinson's disease (PD). Traditionally, the procedure is performed awake and under local anaesthesia to facilitate intraoperative monitoring via microelectrode recording and test stimulation for exact electrode positioning. Advances in MR imaging allow for clear visualization of the STN and therefore direct targeting. Retrospective series suggest that MRI-guided and image (CT or MRI)-verified STN-DBS under general anaesthesia yields a similar motor outcome and quality of life (QoL) as awake and microelectrode recording-guided surgery with intra-operative clinical testing. MRI-guided and image (CT or MRI)- verified approach potentially has advantages in terms of patient experience and cost-effectiveness. The study proposed here is the first in the world to directly compare both methods.

Objective: To compare bilateral MRI-guided and CT-verified STN-DBS under general anaesthesia to awake microelectrode-guided bilateral STN-DBS with intra-operative clinical testing in terms of motor improvement.

Study design: A multicentre comparative effectiveness trial with a non-inferiority design. Study population: 158 PD people eligible for bilateral STN-DBS (79 in each arm).

Intervention: This study compares two modalities of standard treatment. One arm receives awake microelectrode recording guided bilateral STN-DBS under local anaesthesia with intraoperative clinical testing. The other arm receives MRI-guided and CT-verified bilateral STN-DBS under general anaesthesia.

Main study parameters/endpoints: The primary outcome is the change from baseline to one year in Unified Parkinson's Disease Rating Scale part III (UPDRS III) scores (OFF Medication) versus the postoperative scores (OFF medication and ON stimulation). Secondary objectives include patient experience, quality of life, adverse effects and complications, neuropsychological examination, non-motor symptoms (including psychiatric evaluation), reduction in anti-parkinsonian medication, activities of daily living (ADL) functioning and cost- effectiveness.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Awake MER-guided surgical procedure under local anesthesia with intraoperative testing

Awake micro-electrode recording-guided surgical procedure under local anesthesia with intraoperative testing

bilateral STN deep brain stimulation

Intervention Type: PROCEDURE

bilateral deep brain stimulation of the subthalamic nucleus in people with Parkinson's disease

Asleep MRI-guided and CT-verified surgical procedure

Asleep MRI-guided and CT-verified surgical procedure

bilateral STN deep brain stimulation

Intervention Type: PROCEDURE

bilateral deep brain stimulation of the subthalamic nucleus in people with Parkinson's disease

Interventions

bilateral STN deep brain stimulation

bilateral deep brain stimulation of the subthalamic nucleus in people with Parkinson's disease

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 30-75 years of age
• Idiopathic Parkinson's disease (according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease)
• Disease duration ≥ 4 years
• Hoehn & Yahr ≤ 3 (in best ON-medication condition)
• Despite optimal pharmacological treatment, at least one of the following symptoms:
• Disturbing response fluctuation
• Dyskinesia
• Painful dystonia
• Drug-resistant tremor
• ≥30% improvement of Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score in a levodopa challenge test, except for tremor dominant PD. This is conform daily clinical practice in all participating centres.
• Written informed consent

Exclusion Criteria

• Dementia (Montreal Cognitive Assessment ≤ 25)
• Previous neurosurgical procedures for PD
• Structural lesions on brain MRI
• Contra-indications for DBS surgery
• Contra-indications for MRI
• Current depression or history recurrent severe depression
• History of psychosis
• Need for nursing care
• Life expectancy < 2 years

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: collaborator

HagaZiekenhuis

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

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Other Identifiers

2022-13795

Identifier Type: -

Identifier Source: org_study_id