Evidence map›Paper›PMID 37853327›Full record

ArticleBMC neurology2023

Directional versus ring-mode deep brain stimulation for Parkinson's disease: protocol of a multi-centre double-blind randomised crossover trial.

Timo R Ten Brinke, Hannah Jergas, Vibuthi Sisodia, Michael T Barbe, Vincent J J Odekerken, Dagmar Verbaan, Joke M Dijk, Maarten Bot, Martijn Beudel, Pepijn van den Munckhof and 2 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 2 countries.

Timo R Ten BrinkeAmsterdam UMC, University of Amsterdam, Neurology, Meibergdreef 9, Amsterdam, Netherlands.
Hannah JergasDepartment of Neurology, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.
Vibuthi SisodiaAmsterdam UMC, University of Amsterdam, Neurology, Meibergdreef 9, Amsterdam, Netherlands.
Michael T BarbeDepartment of Neurology, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.
Vincent J J OdekerkenAmsterdam UMC, University of Amsterdam, Neurology, Meibergdreef 9, Amsterdam, Netherlands.
Dagmar VerbaanAmsterdam UMC, University of Amsterdam, Neurology, Meibergdreef 9, Amsterdam, Netherlands.
Joke M DijkAmsterdam UMC, University of Amsterdam, Neurology, Meibergdreef 9, Amsterdam, Netherlands.
Maarten BotAmsterdam UMC, University of Amsterdam, Neurology, Meibergdreef 9, Amsterdam, Netherlands.
Martijn BeudelAmsterdam UMC, University of Amsterdam, Neurology, Meibergdreef 9, Amsterdam, Netherlands.
Pepijn van den MunckhofAmsterdam UMC, University of Amsterdam, Neurology, Meibergdreef 9, Amsterdam, Netherlands.
P Rick SchuurmanAmsterdam UMC, University of Amsterdam, Neurology, Meibergdreef 9, Amsterdam, Netherlands.
Rob M A de BieAmsterdam UMC, University of Amsterdam, Neurology, Meibergdreef 9, Amsterdam, Netherlands. r.m.debie@amsterdamumc.nl.
Amsterdam Neuroscience · NLUniversity of Amsterdam · NLAmsterdam University Medical Centers · NLUniversity Hospital Cologne · DEUniversity of Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe effectiveness of Deep Brain Stimulation (DBS) therapy for Parkinson's disease can be limited by side-effects caused by electrical current spillover into structures adjacent to the target area. The objective of the STEEred versus RING-mode DBS for Parkinson's disease (STEERING) study is to investigate if directional DBS for Parkinson's disease results in a better clinical outcome when compared to ring-mode DBS.

methodsThe STEERING study is a prospective multi-centre double-blind randomised crossover trial. Inclusion criteria are Parkinson's disease, subthalamic nucleus DBS in a 'classic' ring-mode setting for a minimum of six months, and optimal ring-mode settings have been established. Participants are categorised into one of two subgroups according to their clinical response to the ring-mode settings as 'responders' (i.e., patient with a satisfactory effect of ring-mode DBS) or 'non-responder' (i.e., patient with a non-satisfactory effect of ring-mode DBS). A total of 64 responders and 38 non-responders will be included (total 102 patients). After an optimisation period in which an optimal directional setting is found, participants are randomised to first receive ring-mode DBS for 56 days (range 28-66) followed by directional DBS for 56 days (28-66) or vice-versa. The primary outcome is the difference between ring-mode DBS and directional DBS settings on the Movement Disorders Society Unified Parkinson's Disease Rating Scale - Motor Evaluation (MDS-UPDRS-ME) in the off-medication state. Secondary outcome measures consist of MDS-UPDRS-ME in the on-medication state, MDS-UPDRS Activities of Daily Living, MDS-UPDRS Motor Complications-Dyskinesia, disease related quality of life measured with the Parkinson's Disease Questionnaire 39, stimulation-induced side-effects, antiparkinsonian medication use, and DBS-parameters. Participants' therapy preference is measured at the end of the study. Outcomes will be analysed for both responder and non-responder groups, as well as for both groups pooled together. DISCUSSION: The STEERING trial will provide insights into whether or not directional DBS should be standardly used in all Parkinson's disease DBS patients or if directional DBS should only be used in a case-based approach.

trial registrationThis trial was registered on the Netherlands Trial Register, as trial NL6508 ( NTR6696 ) on June 23, 2017.

Indexed as

Deep Brain StimulationParkinson DiseaseActivities of Daily LivingCross-Over StudiesHumansMulticenter Studies as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeDeep brain stimulationDirectional deep brain stimulationParkinson’s diseaseSteering subthalamic nucleus

Identifiers

PMID37853327
PMCPMC10583384
OpenAlexW4387741195

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.