Evidence map›Paper›PMID 40424301›Full record

Trial reportPloS one2025

Repetitive Transcranial Magnetic Stimulation targeted with MRI based neuro-navigation in major depressive episode: a double-blind, multicenter randomized controlled trial.

Bruno Millet, Ghina Harika-Germaneau, Redwan Maatoug, Florian Naudet, Jean-Michel Reymann, Valérie Turmel, Jean-Marie Batail, Jacques Soulabaille, Nematollah Jaafari, Dominique Drapier

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
In one paragraph

Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01677078 (Assessment of the Neuronavigation System Coupled With Repetitive Transcranial Magnetic Stimulation. A Randomized Double Blind Study), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

NCT01677078 nacompletednot on this map

Assessment of the Neuronavigation System Coupled With Repetitive Transcranial Magnetic Stimulation. A Randomized Double Blind Study

TypeinterventionalSponsorRennes University HospitalRan2013 to 2017Enrolled107ConditionsTreatment Resistant DepressionArmsNeuronavigation system, Standard localisation method
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. 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

10 authors.

Bruno MilletInstitut du Cerveau et de la Moelle, UMR, CNRS, INSERM, Sorbonne Université et Département de Psychiatrie Adulte, Groupe Hospitalier Pitié-Salpêtrière, Paris, France.
Ghina Harika-GermaneauCNRS, Université de Poitiers, Université de Tours, CeRCA, Poitiers, FranceUnité de Recherche Clinique Pierre Deniker du Centre Hospitalier Henri Laborit, Poitiers, France.
Redwan MaatougDepartment of Psychiatry, Pitié-Salpêtrière Hospital, Public Hospitals of Sorbonne University, Paris, France.
Florian NaudetUniv Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail) - UMR_S, Rennes, France.ORCID 0000-0003-3760-3801
Jean-Michel ReymannUniv Rennes, CHU Rennes, Centre d'investigation Clinique (CIC) Inserm, Rennes University Hospital, Rennes, France.
Valérie TurmelUniv Rennes, CHU Rennes, Centre d'investigation Clinique (CIC) Inserm, Rennes University Hospital, Rennes, France.
Jean-Marie BatailAdult Psychiatry Department, Guillaume-Régnier Hospital, Univ Rennes, CHU Rennes, Centre d'investigation Clinique (CIC) Inserm, Rennes, France.
Jacques SoulabailleAdult Psychiatry Department, Guillaume-Régnier Hospital, Univ Rennes, CHU Rennes, Centre d'investigation Clinique (CIC) Inserm, Rennes, France.
Nematollah JaafariCNRS, Université de Poitiers, Université de Tours, CeRCA, Poitiers, FranceUnité de Recherche Clinique Pierre Deniker du Centre Hospitalier Henri Laborit, Poitiers, France.
Dominique DrapierAdult Psychiatry Department, Guillaume-Régnier Hospital, Univ Rennes, CHU Rennes, Centre d'investigation Clinique (CIC) Inserm, Rennes, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextHigh-frequency (HF) transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (DLPFC) is widely used in Major Depressive Episode (MDE). Optimization of its efficacy with a neuro-navigation system has been proposed based on a small randomized controlled trial (RCT) supporting a large effect.

methodThis evaluator- and patient-blind, multicenter RCT assessed the superiority in terms of efficacy of 10 HF rTMS sessions of the left DLPFC targeted with MRI based neuro-navigation versus similar sessions targeted by the standard 5 cm technique. The study was conducted between January 2013 and April 2017, at 4 hospitals centers in France where both in- and out- patients with MDE were included. Randomization was computer-generated (1:1), with allocation concealment implemented within the e-CRF. The main outcome measure was the percentage of responders 44 days (D44) after the rTMS session. Secondary outcomes were percentage of remitters, Beck Depression Inventory and psychomotor retardation assessed with Salpêtrière retardation rating scale (SRRS) for depression at D14 and D44. The results are presented along with their 95% confidence intervals.

results105 patients were randomized and 92 were evaluable with respectively 45 patients in the neuronavigation group and 47 in the standard group. A treatment response was observed for 14 (31.8%) of 44 patients analyzed in the intervention group, and for 16 (35.6%) of 45 patients analyzed in the control group with no statistical difference (relative risk 0.89; 95% confidence interval, [0.50;1.61]). No difference was evidenced for secondary outcomes at D44 whether it concerns remission at D44 (relative risk, 0.82; 95% CI, 0.36 to 1.88), or BDI results (difference in means, 0,01; 95% CI, -3.06 to 3.26), or SRRS results (difference in means, 0.11; 95% CI, -2.42 to 5.02). Similar results were observed at D14. Rates of adverse events were similar in both groups with 23 (47.9%) and 1 (2.1%) of adverse events and serious adverse events in the neuro-navigation group versus 20 (40.8%) and 0 (0%) in the standard group. DISCUSSION: This study failed to reproduce previous findings supporting the use of neuro-navigation system to optimize rTMS efficacy. Limitations of this study includes a small sample size and a number of rTMS sessions that may appear substandard in 2025.

trial registrationNCT01677078.

Indexed as

Magnetic Resonance ImagingMajor Depressive DisorderNeuronavigationTranscranial Magnetic StimulationAdultDorsolateral Prefrontal CortexDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment Outcome

Identifiers

PMID40424301
PMCPMC12111610

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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.