Low intensity transcranial electrical stimulation for schizophrenia: a triple-blind, randomized, sham-controlled multicenter trial (STIM’Zo)

Persistent symptoms in schizophrenia remain a major therapeutic challenge. Noninvasive electrical stimulation such as transcranial random noise stimulation (tRNS) may alleviate auditory hallucinations and negative symptoms, although existing evidence is limited to case reports and pilot studies. In a triple blind sham-controlled study, we aimed to assess the safety and clinical efficacy of tRNS as an add-on treatment for persistent symptoms in schizophrenia.The primary outcome was clinical response at Day 5, defined as ≥ 25% reduction in PANSS total score. Secondary outcomes included symptom assessments at 1, 3, and 6 months. The primary analysis was performed in 132 patients (64 in the active group: 21 females/43 males; 68 in the sham group: 22 females/46 males). At Day 5, clinical response occurred in 6/64 (9.4%) patients in the active group and 9/68 (13.2%) in the sham group, with no significant difference between groups (-0.38, 95% CI [-1.64, 0.89], p = 0.56). No significant differences were found for secondary outcomes. Serious adverse events unrelated to treatment occurred in 5 (active) vs 7 (sham) patients (0.74, 95% CI [0.17, 2.88], p = 0.76). tRNS was safe and well tolerated but did not show superiority over sham in reducing persistent symptoms of schizophrenia. Trials.gov NCT02744989.

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Publication Details

Journal
BMC Medicine
Published
2026-09-19
DOI
https://doi.org/10.1186/s12916-026-05227-7
Primary Topic
Transcranial Magnetic Stimulation Studies
Type
article
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article

Low intensity transcranial electrical stimulation for schizophrenia: a triple-blind, randomized, sham-controlled multicenter trial (STIM’Zo)

Clément Nathou, Michel Benoît, Emmanuel Poulet, Julie Haesebaert et al.
BMC Medicine
Transcranial Magnetic Stimulation Studies
article

Low intensity transcranial electrical stimulation for schizophrenia: a triple-blind, randomized, sham-controlled multicenter trial (STIM’Zo)

Clément Nathou, Michel Benoît, Emmanuel Poulet, Julie Haesebaert, Laurent Magaud, Marion Plaze, Marine Mondino, Jérôme Attal, P.M. Llorca, David Szekely, Filipe Galvão, Wissam El-Hage, Eric Fakra, Renaud Jardri, Jerome Brunelin
article en

Abstract

Persistent symptoms in schizophrenia remain a major therapeutic challenge. Noninvasive electrical stimulation such as transcranial random noise stimulation (tRNS) may alleviate auditory hallucinations and negative symptoms, although existing evidence is limited to case reports and pilot studies. In a triple blind sham-controlled study, we aimed to assess the safety and clinical efficacy of tRNS as an add-on treatment for persistent symptoms in schizophrenia.The primary outcome was clinical response at Day 5, defined as ≥ 25% reduction in PANSS total score. Secondary outcomes included symptom assessments at 1, 3, and 6 months. The primary analysis was performed in 132 patients (64 in the active group: 21 females/43 males; 68 in the sham group: 22 females/46 males). At Day 5, clinical response occurred in 6/64 (9.4%) patients in the active group and 9/68 (13.2%) in the sham group, with no significant difference between groups (-0.38, 95% CI [-1.64, 0.89], p = 0.56). No significant differences were found for secondary outcomes. Serious adverse events unrelated to treatment occurred in 5 (active) vs 7 (sham) patients (0.74, 95% CI [0.17, 2.88], p = 0.76). tRNS was safe and well tolerated but did not show superiority over sham in reducing persistent symptoms of schizophrenia. Trials.gov NCT02744989.

BMC Medicine
Université Claude Bernard Lyon 1 (FR), Université de Tours (FR), Centre National de la Recherche Scientifique (FR), Inserm (FR), Université de Montpellier (FR), Université Paris Cité (FR), Université de Lille (FR), Princess Grace Hospital Centre (MC), Centre Hospitalier Universitaire de Lille (FR), Centre Hospitalier Universitaire de Nice (FR), Centre Hospitalier Universitaire de Montpellier (FR), Centre de Recherche en Neurosciences de Lyon (FR), Centre Hospitalier Universitaire de Tours (FR), Clinical Investigation Center Plurithematic Tours (FR), Hospices Civils de Lyon (FR), University of Clermont Auvergne (FR), Centre Hospitalier Universitaire de Caen Normandie (FR), Sigma Clermont (FR), Centre Hospitalier Sainte-Anne (FR), Institut de Psychiatrie et Neurosciences de Paris (FR), Centre Hospitalier Le Vinatier (FR), Clermont Université (FR), FHU Neurovasc (FR), Centre Hospitalier Universitaire de Saint-Étienne (FR), Université de Caen Normandie (FR)
Good health and well-being
Openalex Percentile: Top 13%
Transcranial Magnetic Stimulation Studies
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