Protocol published for trial testing tDCS plus cognitive training in schizophrenia
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Key Takeaway
Note: This is a protocol; no efficacy or safety results are available.
A published study protocol outlines a future randomized controlled trial. The trial will enroll 120 adults aged 18-65 years with clinically stable schizophrenia (DSM-5 criteria) at a single clinical center. Participants will be randomized to receive either active transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex or sham stimulation, both followed by cognitive remediation therapy using the RehaCom system.
The primary outcome is the change in cognitive performance measured with the CANTAB battery. Secondary outcomes include symptom severity (PANSS), global clinical status (CGI-S), and neurophysiological changes measured by EEG. Follow-up assessments are planned for 8 weeks after the intervention.
No results, effect sizes, or statistical data are reported, as this is a protocol for a trial that has not yet been conducted. Safety and tolerability data, including adverse events and discontinuations, are also not reported. The protocol does not list specific study limitations, but the key limitation is that it is a plan for research, not a report of findings. The practice relevance of this intervention cannot be assessed without trial results.
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View Original Abstract ↓
Background Cognitive impairment is a core feature of schizophrenia and a major determinant of functional disability. Executive deficits affect approximately 85% of patients and are associated with reduced activity in the prefrontal cortex (hypofrontality). Current pharmacological treatments show limited efficacy in improving cognition, highlighting the need for alternative therapeutic approaches. Combining non-invasive brain stimulation with cognitive remediation may enhance neuroplasticity and improve cognitive outcomes. Methods This prospective, randomized, double-blind, sham-controlled, parallel-group superiority clinical trial. A total of 120 adults aged 18-65 years with clinically stable schizophrenia diagnosed according to DSM-5 criteria will be enrolled at a single clinical center. Participants will be randomly assigned in a 1:1 ratio to receive either active transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex followed by cognitive remediation therapy (CRT) using the RehaCom system, or sham stimulation followed by the same cognitive training. Assessments will be conducted at three time points: prior to the intervention (V1), immediately after the intervention (V2), and during the follow-up visit 8 weeks after the intervention (V3). The primary outcome is change in cognitive performance measured with the CANTAB battery. Secondary outcomes include symptom severity assessed with the PANSS, global clinical status (CGI-S), and neurophysiological changes measured by EEG. Written informed consent will be obtained from all participants, and the study has received ethics committee approval. Discussion This trial will evaluate whether tDCS administered prior to cognitive training enhances cognitive improvement compared with cognitive training alone. The findings may inform the development of more effective interventions targeting cognitive deficits in schizophrenia. Trial registration ClinicalTrials.gov Identifier: NCT07273175. Registered on 25 November 2025.
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