Evidence map›Paper›PMID 31014369›Full record

ArticleTrials2019

Structural and functional brain biomarkers of clinical response to rTMS of medication-resistant auditory hallucinations in schizophrenia patients: study protocol for a randomized sham-controlled double-blind clinical trial.

Fanny Thomas, Noomane Bouaziz, Cécile Gallea, Palmyre Schenin-King Andrianisaina, Florence Durand, Ombline Bolloré, René Benadhira, Clémence Isaac, Sonia Braha-Zeitoun, Virginie Moulier and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02755623 (Structural and Functional Correlates of Clinical Response to Repetitive Transcranial Magnetic Stimulation), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT02755623 naunknown statusnot on this map

Structural and Functional Correlates of Clinical Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Schizophrenia Patients With Resistant Auditory Hallucinations

TypeinterventionalSponsorCentre hospitalier de Ville-Evrard, FranceRan2015 to 2025Enrolled45ConditionsSchizophreniaArmsRepetitive Transcranial Magnetic Stimulation (rTMS), Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
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  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

12 authors.

Fanny ThomasUnité de Recherche Clinique, Établissement Public de Santé Ville-Evrard, 202 avenue Jean Jaurès, 93332, Neuilly-sur-Marne, France.ORCID http://orcid.org/0000-0002-8172-7193
Noomane BouazizUnité de Recherche Clinique, Établissement Public de Santé Ville-Evrard, 202 avenue Jean Jaurès, 93332, Neuilly-sur-Marne, France.
Cécile GalleaMovement Investigations and Therapeutics, MOV'IT, Centre de Recherche de l'Institut du Cerveau et de la Moelle Épinière, CNRS UMR 7225, INSERM UMRS 1127 and Université Pierre et Marie Curie, 47 boulevard de l'Hôpital, 75013, Paris, France.
Palmyre Schenin-King AndrianisainaUnité de Recherche Clinique, Établissement Public de Santé Ville-Evrard, 202 avenue Jean Jaurès, 93332, Neuilly-sur-Marne, France.
Florence DurandUnité de Recherche Clinique, Établissement Public de Santé Ville-Evrard, 202 avenue Jean Jaurès, 93332, Neuilly-sur-Marne, France.
Ombline BolloréUnité de Recherche Clinique, Établissement Public de Santé Ville-Evrard, 202 avenue Jean Jaurès, 93332, Neuilly-sur-Marne, France.
René BenadhiraUnité de Recherche Clinique, Établissement Public de Santé Ville-Evrard, 202 avenue Jean Jaurès, 93332, Neuilly-sur-Marne, France.
Clémence IsaacUnité de Recherche Clinique, Établissement Public de Santé Ville-Evrard, 202 avenue Jean Jaurès, 93332, Neuilly-sur-Marne, France.
Sonia Braha-ZeitounUnité de Recherche Clinique, Établissement Public de Santé Ville-Evrard, 202 avenue Jean Jaurès, 93332, Neuilly-sur-Marne, France.
Virginie MoulierUnité de Recherche Clinique, Établissement Public de Santé Ville-Evrard, 202 avenue Jean Jaurès, 93332, Neuilly-sur-Marne, France.
Antoni Valero-CabréCerebral Dynamics, Plasticity and Rehabilitation Group, Frontlab, Centre de Recherche de l'Institut du Cerveau et de la Moelle Épinière, CNRS UMR 7225, INSERM UMRS 1127 and Université Pierre et Marie Curie, 47 boulevard de l'Hôpital, 75013, Paris, France. antoni.valerocabre@icm-institute.org.
Dominique JanuelUnité de Recherche Clinique, Établissement Public de Santé Ville-Evrard, 202 avenue Jean Jaurès, 93332, Neuilly-sur-Marne, France. domjanuel@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe potential of non-invasive repetitive transcranial magnetic stimulation (rTMS) to improve auditory verbal hallucinations (AVH) in schizophrenia patients has been increasingly explored over the past decade. Despite highly promising results, high inter-individual variability of clinical response and ineffective outcomes in a significant number of patients underscored the need to identify factors associated with the clinical response to rTMS. It should help improve the efficacy of rTMS in patients with medication-resistant AVH, and allow a better understanding of its neural impact. Here, we describe an exploratory study protocol which aims to identify structural and functional brain biomarkers associated with clinical response after an rTMS treatment for medication-resistant AVH in schizophrenia.

methodsForty-five schizophrenia patients with medication-resistant AVH will be enrolled in a double-blind randomized sham-controlled monocentric clinical trial. Patients will be assigned to a regime of 20 sessions of active or sham 1 Hz rTMS delivered twice a day, 5 days a week for 2 weeks over the left temporo-parietal junction. Response will be assessed after rTMS and patients will be classified in responders or non-responders to treatment. Magnetic resonance imaging (MRI) sessions including diffusion weighted imaging and resting-state functional MRI sequences will be recorded before the onset of the rTMS treatment and 3 days following its discontinuation. The primary outcome measure is difference in fractional anisotropy between responder and non-responder patients at baseline. Differences in resting-state functional MRI data at baseline will be also investigated between responder and non-responder groups. Clinical, neuropsychological, neurophysiological, and blood serum BDNF assessments will be performed at baseline, 3 days, 1 month, and 3 months following rTMS. DISCUSSION: The aim of this research project is to identify and assess the biomarker value of MRI-based structural and functional biomarkers predicting clinical response to rTMS for AVH in schizophrenia patients. The outcome of the trial should improve patient care by offering them a novel suitable therapy and deepen our understanding on how rTMS may impact AVH and develop more effective therapies adapted to individual patient needs.

trial registrationClinicalTrials.gov, NCT02755623 . Registered on 22 April 2016.

Indexed as

Auditory PerceptionHallucinationsSchizophrenic PsychologyTranscranial Direct Current StimulationAdolescentAdultAgedBiomarkersBrainBrain-Derived Neurotrophic FactorBrain MappingDiffusion Magnetic Resonance ImagingDouble-Blind MethodDrug ResistanceFemaleFranceBDNF protein, humanBiomarkersBrain-Derived Neurotrophic Factorauditory verbal hallucinationsclinical responseclinical trialfunctional connectivitynon-invasive brain stimulationpredictive biomarkersrepetitive transcranial magnetic stimulationSchizophreniastructural connectivity

Identifiers

PMID31014369
PMCPMC6480831

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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.