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

NCT05453331 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 158

Last updated 2022-07-12

No results posted yet for this study

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

Interventions

PROCEDURE

bilateral STN deep brain stimulation

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

Sponsors & Collaborators

  • Maastricht University Medical Center

    collaborator OTHER

  • HagaZiekenhuis

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2025-03-31
Completion
2025-05-31

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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 NCT05453331 on ClinicalTrials.gov