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

NCT05453331 | Unknown

• 1 other identifier: 2022-13795
• Study Type: observational
• Target: 158
• Locations: 0 countries
• Sites: N/A

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

Keywords

Deep Brain Stimulation; Parkinson Disease; subthalamic nucleus

Outcome Measures

Primary Outcomes (1)

• Unified Parkinson's Disease Rating Scale part III

  change from baseline to 1 year in Unified Parkinson's Disease Rating Scale part III (min 0, max. 132; higher score means worse outcome)

  12 months

Secondary Outcomes (16)

• reduction in anti-parkinsonian medication

  12 months

• health-related quality of life

  12 months

• Non-motor aspects of experiences of daily living

  12 months

• Motor aspects of experiences of daily living measured

  12 months

• Motor complications after DBS surgery

  12 months

Study Arms (2)

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

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

Procedure: bilateral STN deep brain stimulation

Asleep MRI-guided and CT-verified surgical procedure

Asleep MRI-guided and CT-verified surgical procedure

Procedure: bilateral STN deep brain stimulation

Interventions

bilateral STN deep brain stimulation PROCEDURE

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

Asleep MRI-guided and CT-verified surgical procedure; Awake MER-guided surgical procedure under local anesthesia with intraoperative testing

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

poeple with Parkinson's disease eligible for bilateral STN-DBS

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Maastricht University Medical Center: collaborator
• HagaZiekenhuis: collaborator

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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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 12, 2022
• Study Start: October 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 12, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share