Clinical trial NCT05453331: Asleep MRI-guided Versus Awake Microelectrode Recording Guided Deep Brain Stimulation in Parkinson's Disease: A Comparative Effectiveness Trial
Official title: Asleep MRI-guided and CT-verified Versus Awake Microelectrode Recording Guided Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease: A Comparative Effectiveness Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Parkinson Disease
subthalamic nucleus
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
name: HagaZiekenhuis
First posted: 2022-07-12
Enrollment: 158
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: poeple with Parkinson's disease eligible for bilateral STN-DBS

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.


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

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale part III
timeFrame: 12 months
Secondary outcomes:
measure: reduction in anti-parkinsonian medication
timeFrame: 12 months
measure: health-related quality of life
timeFrame: 12 months
measure: Non-motor aspects of experiences of daily living
timeFrame: 12 months
measure: Motor aspects of experiences of daily living measured
timeFrame: 12 months
measure: Motor complications after DBS surgery
timeFrame: 12 months
measure: Patient experience and satisfaction
timeFrame: during hospitalization and follow up visits at approximately 2 weeks after surgery, 6 and 12 months
measure: Depressive symptoms
timeFrame: 12 months
measure: Non-Motor Symptoms
timeFrame: 12 months
measure: Impulsivity
timeFrame: 12 months
measure: Cognitive impairment
timeFrame: 12 months
measure: Anxiety
timeFrame: 12 months
measure: Autonomic symptoms
timeFrame: 12 months
measure: Neuropsychiatric symptoms
timeFrame: 12 months
measure: Patient's sleepiness
timeFrame: 12 months
measure: Complications and (serious) adverse effects
timeFrame: 12 months
measure: Cost effectiveness
timeFrame: during hospitalization (range 3-5 days, median 4 days)
Other outcomes:
Locations:
Study officials:
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