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Structural and Functional Correlates of Clinical Response to rTMS Treatment in Schizophrenia Patients With Resistant Auditory Hallucinations

NCT02755623 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-02-15

No results posted yet for this study

Summary

The potential of non-invasive Transcranial Magnetic Stimulation (TMS) as a therapeutic tool for improving schizophrenic symptoms, in particular resistant hallucinations, has been increasingly studied over the past decades. Several studies have demonstrated that low-frequency patterns of repetitive TMS (rTMS) applied over the left Temporoparietal Junction (TPJ), which are known to decrease local activity, significantly reduced auditory verbal hallucinations in schizophrenic patients. In spite of highly promising results, a high level of inter-individual variability in the responses to non-invasive brain stimulation treatments, and the fact that rTMS may prove ineffective in some patients, keep spurring controversy about the efficacy of these approaches (as currently performed), as well as about how to increase its efficacy and consistency. Accordingly, the objectives of this project are to better understand the impact of rTMS on the brains of patients with resistant auditory hallucinations, and to use this information not only to better understand this condition but to develop more efficient and consistent therapies. Thus, in this study, the investigators focus more specifically on resistant auditory hallucinations in schizophrenia, which is a common symptom in schizophrenic patients, and can be treated by rTMS. The investigators hypothesize that there is a baseline difference in anatomical and/or functional connectivity between responder and non-responder patients who are treated with rTMS. Therefore, our project will aim to determine some anatomical and functional connectivity markers of response to rTMS treatment in patients with schizophrenia

Conditions

Interventions

DEVICE

Repetitive Transcranial Magnetic Stimulation (rTMS)

Participants are sequentially randomly assigned to either 20 active rTMS sessions or 20 sham rTMS sessions that were applied over the left temporoparietal junction. Treatments are administered daily, over a period of two weeks.

DEVICE

Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Sponsors & Collaborators

  • Centre hospitalier de Ville-Evrard, France

    lead OTHER

Principal Investigators

  • Fanny Thomas, BIOLOGISTE · Unité de Recherche Clinique, EPS Ville Evrard, Neuilly-sur-Marne,, France, 93330

  • Dominique Januel, MD, PhD · Unité de Recherche Clinique, EPS Ville Evrard, Neuilly-sur-Marne,, France, 93330

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-14
Primary Completion
2025-09-08
Completion
2025-10-08

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02755623 on ClinicalTrials.gov