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Parkinson DiseaseACCURATENCT05453331

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

An observational study of Parkinson Disease, run by Radboud University Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Parkinson Disease
What is being tested?
bilateral STN deep brain stimulation
Type of treatment
Surgery or procedure
How many people
158 participants
Where
No sites listed yet
Study dates
Oct 2022to May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • History of psychosis
  • Need for nursing care
  • Life expectancy < 2 years

About this study

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

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.

Read more

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.

Being tested
bilateral STN deep brain stimulation
Keywords
Deep Brain Stimulation, Parkinson Disease, subthalamic nucleus
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bilateral STN deep brain stimulationProcedure or surgery

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

Study groups in NCT05453331
Study groupRoleWhat they receive
Awake MER-guided surgical procedure under local anesthesia with intraoperative testingAwake micro-electrode recording-guided surgical procedure under local anesthesia with intraoperative testing
Receives: Procedure: bilateral STN deep brain stimulation
Asleep MRI-guided and CT-verified surgical procedureAsleep MRI-guided and CT-verified surgical procedure
Receives: Procedure: bilateral STN deep brain stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 12 months

Secondary outcomes (16)

  1. reduction in anti-parkinsonian medication

    change from baseline to 1 year in levodopa equivalent daily dose (LEDD)

    Measured: 12 months

  2. 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)

    Measured: 12 months

  3. 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)

    Measured: 12 months

  4. 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)

    Measured: 12 months

  5. 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)

    Measured: 12 months

  6. Patient experience and satisfaction

    Deep Brain Stimulation Patient Experience Rating Scale (min. 0, max. 224, higher score means better outcome)

    Measured: during hospitalization and follow up visits at approximately 2 weeks after surgery, 6 and 12 months

  7. 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)

    Measured: 12 months

  8. 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)

    Measured: 12 months

  9. 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)

    Measured: 12 months

  10. Cognitive impairment

    change from baseline to 1 year in Montreal Cognitive Assignment (MoCA; min. 0, max. 30, higher score means better outcome)

    Measured: 12 months

  11. Anxiety

    change from baseline to 1 year in Parkinson Anxiety Scale (PAS, min. 0, max. 12, higher score means worse outcome)

    Measured: 12 months

  12. 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)

    Measured: 12 months

  13. Neuropsychiatric symptoms

    change from baseline to 1 year in he Neuropsychiatric Inventory Questionnaire (NPI-Q, min. 0, max. 36, higher score means worse outcome)

    Measured: 12 months

  14. Patient's sleepiness

    change from baseline to 1 year in the Epworth Sleepiness Scale (ESS; min. 0, max. 24; higher score means worse outcome)

    Measured: 12 months

  15. Complications and (serious) adverse effects

    measured with a standardized check list

    Measured: 12 months

  16. Cost effectiveness

    measured indirectly by duration of operation and duration of hospitalization

    Measured: during hospitalization (range 3-5 days, median 4 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2022
  2. Study startOct 2022 (estimated)
  3. Primary completionMar 2025 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
158 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05453331
Sponsor's protocol ID
2022-13795
Acronym
ACCURATE
Status last verified
Jun 2022
First submitted
27 Jun 2022
Last updated
12 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Abosch A, Timmermann L, Bartley S, Rietkerk HG, Whiting D, Connolly PJ, Lanctin D, Hariz MI. An international survey of deep brain stimulation procedural steps. Stereotact Funct Neurosurg. 2013;91(1):1-11. doi: 10.1159/000343207. Epub 2012 Nov 13.

    PubMed 23154755

  • Ashkan K, Blomstedt P, Zrinzo L, Tisch S, Yousry T, Limousin-Dowsey P, Hariz MI. Variability of the subthalamic nucleus: the case for direct MRI guided targeting. Br J Neurosurg. 2007 Apr;21(2):197-200. doi: 10.1080/02688690701272240.

    PubMed 17453788

  • Binder DK, Rau GM, Starr PA. Risk factors for hemorrhage during microelectrode-guided deep brain stimulator implantation for movement disorders. Neurosurgery. 2005 Apr;56(4):722-32; discussion 722-32. doi: 10.1227/01.neu.0000156473.57196.7e.

    PubMed 15792511

  • Chaudhuri KR, Martinez-Martin P, Brown RG, Sethi K, Stocchi F, Odin P, Ondo W, Abe K, Macphee G, Macmahon D, Barone P, Rabey M, Forbes A, Breen K, Tluk S, Naidu Y, Olanow W, Williams AJ, Thomas S, Rye D, Tsuboi Y, Hand A, Schapira AH. The metric properties of a novel non-motor symptoms scale for Parkinson's disease: Results from an international pilot study. Mov Disord. 2007 Oct 15;22(13):1901-11. doi: 10.1002/mds.21596.

    PubMed 17674410

  • Chen T, Mirzadeh Z, Chapple KM, Lambert M, Shill HA, Moguel-Cobos G, Troster AI, Dhall R, Ponce FA. Clinical outcomes following awake and asleep deep brain stimulation for Parkinson disease. J Neurosurg. 2018 Mar 16;130(1):109-120. doi: 10.3171/2017.8.JNS17883. Epub 2018 Mar 16.

    PubMed 29547091

  • Chircop C, Dingli N, Aquilina A, Zrinzo L, Aquilina J. MRI-verified "asleep" deep brain stimulation in Malta through cross border collaboration: clinical outcome of the first five years. Br J Neurosurg. 2018 Aug;32(4):365-371. doi: 10.1080/02688697.2018.1478061. Epub 2018 May 26.

    PubMed 29806504

  • Counelis GJ, Simuni T, Forman MS, Jaggi JL, Trojanowski JQ, Baltuch GH. Bilateral subthalamic nucleus deep brain stimulation for advanced PD: correlation of intraoperative MER and postoperative MRI with neuropathological findings. Mov Disord. 2003 Sep;18(9):1062-5. doi: 10.1002/mds.10489.

    PubMed 14502679

  • Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.

    PubMed 9153155

  • Deuschl G, Schade-Brittinger C, Krack P, Volkmann J, Schafer H, Botzel K, Daniels C, Deutschlander A, Dillmann U, Eisner W, Gruber D, Hamel W, Herzog J, Hilker R, Klebe S, Kloss M, Koy J, Krause M, Kupsch A, Lorenz D, Lorenzl S, Mehdorn HM, Moringlane JR, Oertel W, Pinsker MO, Reichmann H, Reuss A, Schneider GH, Schnitzler A, Steude U, Sturm V, Timmermann L, Tronnier V, Trottenberg T, Wojtecki L, Wolf E, Poewe W, Voges J; German Parkinson Study Group, Neurostimulation Section. A randomized trial of deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Aug 31;355(9):896-908. doi: 10.1056/NEJMoa060281.

    PubMed 16943402

  • Dorsey ER, Sherer T, Okun MS, Bloem BR. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis. 2018;8(s1):S3-S8. doi: 10.3233/JPD-181474.

    PubMed 30584159

  • Ford I, Norrie J. Pragmatic Trials. N Engl J Med. 2016 Aug 4;375(5):454-63. doi: 10.1056/NEJMra1510059. No abstract available.

    PubMed 27518663

  • Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.

    PubMed 19025984

  • Gorgulho A, De Salles AA, Frighetto L, Behnke E. Incidence of hemorrhage associated with electrophysiological studies performed using macroelectrodes and microelectrodes in functional neurosurgery. J Neurosurg. 2005 May;102(5):888-96. doi: 10.3171/jns.2005.102.5.0888.

    PubMed 15926715

  • Hariz M, Blomstedt P, Limousin P. The myth of microelectrode recording in ensuring a precise location of the DBS electrode within the sensorimotor part of the subthalamic nucleus. Mov Disord. 2004 Jul;19(7):863-864. doi: 10.1002/mds.20135. No abstract available.

    PubMed 15254958

  • Hariz MI, Krack P, Melvill R, Jorgensen JV, Hamel W, Hirabayashi H, Lenders M, Wesslen N, Tengvar M, Yousry TA. A quick and universal method for stereotactic visualization of the subthalamic nucleus before and after implantation of deep brain stimulation electrodes. Stereotact Funct Neurosurg. 2003;80(1-4):96-101. doi: 10.1159/000075167.

    PubMed 14745216

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Radboud University Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unified Parkinson's Disease Rating Scale part III (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05453331, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.

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