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

July 11, 2022 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
bilateral deep brain stimulation of the subthalamic nucleus in people with Parkinson's disease
Asleep MRI-guided and CT-verified surgical procedure
Procedure: bilateral STN deep brain stimulation
bilateral deep brain stimulation of the subthalamic nucleus in people with Parkinson's disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease Rating Scale part III
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction in anti-parkinsonian medication
Time Frame: 12 months
change from baseline to 1 year in levodopa equivalent daily dose (LEDD)
12 months
health-related quality of life
Time Frame: 12 months
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
Non-motor aspects of experiences of daily living
Time Frame: 12 months
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
Motor aspects of experiences of daily living measured
Time Frame: 12 months
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
Motor complications after DBS surgery
Time Frame: 12 months
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
Patient experience and satisfaction
Time Frame: during hospitalization and follow up visits at approximately 2 weeks after surgery, 6 and 12 months
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
Depressive symptoms
Time Frame: 12 months
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
Non-Motor Symptoms
Time Frame: 12 months
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
Impulsivity
Time Frame: 12 months
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
Cognitive impairment
Time Frame: 12 months
change from baseline to 1 year in Montreal Cognitive Assignment (MoCA; min. 0, max. 30, higher score means better outcome)
12 months
Anxiety
Time Frame: 12 months
change from baseline to 1 year in Parkinson Anxiety Scale (PAS, min. 0, max. 12, higher score means worse outcome)
12 months
Autonomic symptoms
Time Frame: 12 months
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
Neuropsychiatric symptoms
Time Frame: 12 months
change from baseline to 1 year in he Neuropsychiatric Inventory Questionnaire (NPI-Q, min. 0, max. 36, higher score means worse outcome)
12 months
Patient's sleepiness
Time Frame: 12 months
change from baseline to 1 year in the Epworth Sleepiness Scale (ESS; min. 0, max. 24; higher score means worse outcome)
12 months
Complications and (serious) adverse effects
Time Frame: 12 months
measured with a standardized check list
12 months
Cost effectiveness
Time Frame: during hospitalization (range 3-5 days, median 4 days)
measured indirectly by duration of operation and duration of hospitalization
during hospitalization (range 3-5 days, median 4 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Maastricht University Medical Center
HagaZiekenhuis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

June 27, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-13795

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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