NCT05440955: STICOG

tDCS for Cognitive Impairment Associated With Recent-onset Schizophrenia

Not yet recruiting NA Last updated 4 April 2023

What this trial tests

NA trial testing left fronto-temporal transcranial Direct Current Stimulation (tDCS) in Schizophrenia in 60 participants. Not yet recruiting.

Timeline

1 June 2023

Primary endpoint
1 June 2026

1 June 2027

Quick facts

Lead sponsor	University Hospital, Grenoble
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 June 2023
Primary completion	1 June 2026
Estimated completion	1 June 2027
Sites	4 locations across France

Drugs / interventions tested

• left fronto-temporal transcranial Direct Current Stimulation (tDCS)

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Psychotic Disorder — all drugs for Psychotic Disorder →

Sponsor

University Hospital, Grenoble

Who can join

Adults 18 to 35, any sex, with Schizophrenia or Psychotic Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: In parallel to the traditional symptomatology, deficits in cognition (memory, attention, reasoning, social functioning) contribute significantly to disability and suffering in individuals with schizophrenia. Cognitive deficits have been closely linked to alterations in early auditory processes (EAP) that occur in auditory cortical areas. Preliminary evidence indicates that cognitive deficits in schizophrenia can be improved with a reliable and safe non-invasive brain stimulation technique called tDCS (transcranial Direct Current Stimulation). However, a significant proportion of patients derive no cognitive benefits after tDCS treatment. Further, the neurobiological mechanisms of cognitive changes after tDCS have been poorly explored in trials and are thus still unclear.

Method: The study is designed as a randomized, double-blind, 2-arm parallel-group, sham controlled, 4-centers trial. Sixty participants with recent-onset schizophrenia and cognitive impairment will be randomly allocated to receive either active (n=30) or sham (n=30) tDCS (20-min, 2-mA, 10 sessions during 5 consecutive weekdays). The anode will be placed over the left dorsolateral prefrontal cortex and the cathode over the left auditory cortex. Cognition, tolerance, symptoms, general outcome and EAP (measured with EEG and multimodal MRI) will be assessed prior to tDCS (baseline), after the 10 sessions, and at 1- and 3-month follow-up. The primary outcome will be the number of responders, defined as participants demonstrating a cognitive improvement ≥Z=0.5 from baseline on the MATRICS Consensus Cognitive Battery total score at 1-month follow-up. Additionally, we will measure how differences in EAP modulate individual cognitive benefits from active tDCS and whether there are changes in EAP measures in responders after active tDCS.

Discussion: Besides proposing a new fronto-temporal tDCS protocol by targeting the auditory cortical areas, we aim to conduct an RCT with follow-up assessments up to 3-months and a large sample size. In addition, this study will allow identifying and assessing the value of a wide range of neurobiological EAP measures for predicting and explaining cognitive deficits improvement after tDCS. The results of this trial will constitute a step toward the use of tDCS as a therapeutic tool for the treatment of cognitive impairment in recent-onset schizophrenia.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Finding the Right Dose: NMDA Receptor-Modulating Treatments for Cognitive and Plasticity Deficits in Schizophrenia and the Role of Pharmacodynamic Target Engagement.
   Sehatpour P, Kantrowitz JT. · · 2025 · cited 12× · PMID 39218136 · DOI 10.1016/j.biopsych.2024.08.019
2. Efficacy and auditory biomarker analysis of fronto-temporal transcranial direct current stimulation (tDCS) in targeting cognitive impairment associated with recent-onset schizophrenia: study protocol for a multicenter randomized double-blind sham-controlled trial.
   Dondé C, Bastin J, Pouchon A, Costes N, et al · · 2023 · PMID 36829240 · DOI 10.1186/s13063-023-07160-z
3. Efficacy and auditory biomarker analysis of fronto-temporal transcranial direct current stimulation (tDCS) in targeting cognitive impairment associated with recent-onset schizophrenia: study protocol for a multicentric randomized double-blind sham-controlled trial
   DONDÉ C, Bastin J, Pouchon A, Costes N, et al · · 2022 · DOI 10.21203/rs.3.rs-1916695/v1