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

Parkinson Disease Clinical Trial

— ACCURATE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05453331
• Other study ID #: 2022-13795
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: May 2025

Study information

• Verified date: June 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 158
• Est. completion date: May 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• bilateral STN deep brain stimulation
bilateral deep brain stimulation of the subthalamic nucleus in people with Parkinson's disease

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University Medical Center	HagaZiekenhuis, Maastricht University Medical Center

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	reduction in anti-parkinsonian medication	change from baseline to 1 year in levodopa equivalent daily dose (LEDD)	12 months
Secondary	health-related quality of life	change from baseline to 1 year in the 39-item Parkinson's Disease Questionnaire (PDQ-39; min. 0, max. 156; higher score means worse outcome)	12 months
Secondary	Non-motor aspects of experiences of daily living	change from baseline to 1 year in Unified Parkinson's Disease Rating Scale part I (min. 0, max. 52; higher score means worse outcome)	12 months
Secondary	Motor aspects of experiences of daily living measured	change from baseline to 1 year in Unified Parkinson's Disease Rating Scale part II (min. 0, max. 52; higher score means worse outcome)	12 months
Secondary	Motor complications after DBS surgery	change from baseline to 1 year in Unified Parkinson's Disease Rating Scale part IV (min. 0, max. 24; higher score means worse outcome)	12 months
Secondary	Patient experience and satisfaction	Deep Brain Stimulation Patient Experience Rating Scale (min. 0, max. 224, higher score means better outcome)	during hospitalization and follow up visits at approximately 2 weeks after surgery, 6 and 12 months
Secondary	Depressive symptoms	change from baseline to 1 year in Beck Depression Inventory-Second Edition (BDI-II; min. 0, max. 63, higher score means worse outcome)	12 months
Secondary	Non-Motor Symptoms	change from baseline to 1 year in Non-Motor Symptoms Assessment Scale (NMSS) for Parkinson's disease (min. 0, max. 360, higher score means worse outcome)	12 months
Secondary	Impulsivity	change from baseline to 1 year in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease (QUIP; min. 0, max. 112, higher score means worse outcome)	12 months
Secondary	Cognitive impairment	change from baseline to 1 year in Montreal Cognitive Assignment (MoCA; min. 0, max. 30, higher score means better outcome)	12 months
Secondary	Anxiety	change from baseline to 1 year in Parkinson Anxiety Scale (PAS, min. 0, max. 12, higher score means worse outcome)	12 months
Secondary	Autonomic symptoms	change from baseline to 1 year in Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT, min. 0, max. 69, higher score means worse outcome)	12 months
Secondary	Neuropsychiatric symptoms	change from baseline to 1 year in he Neuropsychiatric Inventory Questionnaire (NPI-Q, min. 0, max. 36, higher score means worse outcome)	12 months
Secondary	Patient's sleepiness	change from baseline to 1 year in the Epworth Sleepiness Scale (ESS; min. 0, max. 24; higher score means worse outcome)	12 months
Secondary	Complications and (serious) adverse effects	measured with a standardized check list	12 months
Secondary	Cost effectiveness	measured indirectly by duration of operation and duration of hospitalization	during hospitalization (range 3-5 days, median 4 days)