Evidence map›Paper›PMID 39957196›Full record

Trial reportJournal of Parkinson's disease2024

Subthalamic and nigral stimulation for freezing of gait in Parkinson's disease: Randomized pilot trial.

Carlo Alberto Artusi, Claudia Ledda, Silvia Gallo, Domiziana Rinaldi, Corrado Campisi, Vanessa Rousseau, Claire Thalamas, Raquel Barbosa, Fabienne Ory-Magne, Christine Brefel-Courbon and 10 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Parkinson's disease, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05415774 (Combined Deep Brain Stimulation of the Substantia Nigra Pars Reticulata and of the Subthalamic Nucleus for Unresponsive Freezing of Gait in Parkinson's Disease), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT05415774 nacompletednot on this map

Combined Deep Brain Stimulation of the Substantia Nigra Pars Reticulata and of the Subthalamic Nucleus for Unresponsive Freezing of Gait in Parkinson's Disease: a Pilot Cross-over Study

TypeinterventionalSponsorUniversity Hospital, ToulouseRan2022 to 2023Enrolled10ConditionsParkinson DiseaseArms1 : S-C1-C2, 2 : S-C2-C1, 3 : C1 - S - C2, 4 : C1 -C2 - S, 5 : C2 - S - C1
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
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

20 authors.

Carlo Alberto ArtusiDepartment of Neurosciences Rita Levi Montalcini, University of Turin, Turin, Italy.ORCID 0000-0001-8579-3772
Claudia LeddaDepartment of Neurosciences Rita Levi Montalcini, University of Turin, Turin, Italy.ORCID 0000-0003-0839-932X
Silvia GalloNeurology Unit, Department of Translational Medicine, University of Piemonte Orientale, Novara, Italy.ORCID 0000-0001-7223-2060
Domiziana RinaldiDepartment of Neuroscience, Mental Health and Sense Organs (NESMOS), Sapienza University of Rome, Via di Grottarossa, 1035-00189, Rome, Italy.
Corrado CampisiDepartment of Neurosciences Rita Levi Montalcini, University of Turin, Turin, Italy.
Vanessa RousseauService de Pharmacologie Médicale et Clinique, Centre Hospitalier Universitaire et Faculté de Médecine de Toulouse, Toulouse, France.
Claire ThalamasCIC INSERM 1436, Université et Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
Raquel BarbosaService de Neurologie, Centre Hospitalier Universitaire, Toulouse, France.
Fabienne Ory-MagneService de Neurologie, Centre Hospitalier Universitaire, Toulouse, France.
Christine Brefel-CourbonService de Neurologie, Centre Hospitalier Universitaire, Toulouse, France.ORCID 0009-0002-7262-2338
Olivier RascolCIC INSERM 1436, Université et Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
Amaury de BarrosDepartment of Neurosurgery, Toulouse University Hospital, Toulouse, France.
Estelle HarrochCIC INSERM 1436, Université et Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
Maurizio ZibettiDepartment of Neurosciences Rita Levi Montalcini, University of Turin, Turin, Italy.ORCID 0000-0002-2939-343X
Mario Giorgio RizzoneDepartment of Neurosciences Rita Levi Montalcini, University of Turin, Turin, Italy.ORCID 0000-0003-3844-3299
Alberto RomagnoloDepartment of Neurosciences Rita Levi Montalcini, University of Turin, Turin, Italy.
Gabriele ImbalzanoDepartment of Neurosciences Rita Levi Montalcini, University of Turin, Turin, Italy.ORCID 0000-0002-4842-529X
Leonardo LopianoDepartment of Neurosciences Rita Levi Montalcini, University of Turin, Turin, Italy.
Jean Luc HouetoDepartment of Neurology, NS-Park/F-CRIN network, Limoges University Hospital; Inserm, U1094, EpiMaCT - Epidemiology of chronic diseases in tropical zone, Limoges Cedex 01, France.
Margherita FabbriCIC INSERM 1436, Université et Centre Hospitalier Universitaire de Toulouse, Toulouse, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFreezing of gait (FoG) is a debilitating symptom of Parkinson's disease (PD) with limited response to dopaminergic medication and subthalamic deep brain stimulation (STN-DBS). Substantia nigra pars reticulata (SNr) stimulation could improve FoG.

objectiveTo analyze the effect of combined STN-SNr stimulation at different frequencies on FoG.

methodsWe performed a double-blind, cross-over, randomized pilot trial involving STN-DBS treated PD patients with FoG. Participants received: high-frequency (HF) STN-DBS (S), combined HF-STN and SNr stimulation (C1), and combined HF-STN and low-frequency (LF) SNr stimulation (C2), for one month each. The primary endpoint was the score change in the New-Freezing-of-Gait-Questionnaire (NFOG-Q). Secondary analyses were performed on motor complications, axial symptoms, daily living activities, psychiatric symptoms, sleep, and patient preference.

resultsFifteen patients received at least one combined stimulation. No significant difference in NFOG-Q scores was found between S, C1, and C2; one-third of patients showed a clinically significant improvement (≥8 points) with combined stimulations. Motor complications improved significantly with C1 and C2 (C1-S: 3.6 ± 3.8 vs. 4.9 ± 3.8, p = 0.046; C2-S: 2.7 ± 3.1 vs. 4.9 ± 3.8, p = 0.005). 80% of patients preferred the combined STN-SNr stimulation while blinded. All adverse events were manageable.

conclusionsOur study did not prove a statistically significant improvement in NFOG-Q with STN-SNr stimulation; however, one-third of patients experienced a clinically meaningful FoG improvement, and the majority preferred to maintain STN-SNr stimulation. STN-SNr stimulation was both safe and effective in addressing motor complications and improving sleep quality, highlighting the importance of further exploration into the effects of combined STN-SNr stimulation.

Indexed as

Deep Brain StimulationGait Disorders, NeurologicOutcome Assessment, Health CareParkinson DiseaseSubstantia NigraSubthalamic NucleusAgedCross-Over StudiesDouble-Blind MethodFemaleHumansMaleMiddle AgedPilot ProjectsTreatment Outcomedeep brain stimulationfreezing of gaitParkinson's diseasesubstantia nigrasubthalamic nucleus

Identifiers

PMID39957196
PMCPMC13348324

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Registered trials

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.