An interventional study of active tDCS and sham tDCS in Cognitive Impairments and Schizophrenia, sponsored by Medical University of Lodz. Enrolling by invitation at 1 site in Poland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Medical University of Lodz · Not applicable, Interventional, and Treatment
The aim of this prospective, randomized, double-blind, placebo-controlled study is to assess whether transcranial direct current stimulation (tDCS) applied prior to RehaCom cognitive training can improve cognitive functioning in individuals diagnosed with schizophrenia.
The study is designed to answer the following main questions:
Participants will receive tDCS targeting the DLPFC, which was selected due to its key involvement in executive cognitive functions. These include working memory, planning, decision-making, inhibitory control, and the regulation of attention, all of which are relevant for modulating cognitive dysfunction in schizophrenia.
The tDCS will be administered using a battery-powered direct current stimulator (DC-Stimulator PLUS, neuroCare, Germany) through two saline-soaked sponge electrodes (5 cm × 7 cm). According to the International 10-20 system, the anodal electrodes will be positioned over the left DLPFC on the sites corresponding to F3, whereas the cathodal electrode will be placed above the right DLPFC, corresponding to F4. The electrode locations were verified using a computational brain model. All sessions will be conducted over five consecutive days (from Monday to Friday), with a 24-hour interval between sessions. Each participant will complete a total of 15 treatment sessions within a three-week period. Stimulation will be administered using the fixed parameters according to the established literature. For the active tDCS condition, a direct current of 2.0 mA will be applied (corresponding to a total charge of 2.4 C, a current density of 0.57 A/m2, and a charge density of 685.7 C/m2), for 20 minutes with ramp-up and ramp-down periods of 20 seconds each. For sham tDCS, the stimulation will utilize the same active tDCS arrangement, with an intensity of 2.0 mA. However, the current will be applied only for the 20 s ramp-up phase at the beginning and the 20 s ramp-down phase at the end of the stimulation. This protocol preserves blinding by mimicking the initial somatosensory sensations typically associated with active tDCS.
The selection of these parameters is grounded in prior evidence which demonstrates their functional specificity and efficacy in modulating cognitive processes in individuals diagnosed with schizophrenia.
All sessions will be conducted by trained personnel, and adverse events will be regularly monitored throughout the study.
Immediately after each tDCS stimulation, patients will undergo a 30-minute cognitive rehabilitation training session using the RehaCom computer system (HASOMED GmbH, Germany). Previous studies show that the time for which changes in neuronal excitability remain are proportional to the duration of stimulation and current used (Nitsche and Paulus, 2000). Based on these data, the authors assume that following a 20-minute tDCS session, the after-effects should last for at least 30 min (and hence the duration of neurocognitive training will be set at 30 min per session). The following programs will be used each week: day 1 (Monday), 3 (Wednesday) and 5 (Friday): EINK - shopping (different memory functions and selective attention), SUSA - selection of items (sustained attention), WOME - card games (working memory); day 2 (Tuesday) and 4 (Thursday): GEAU - maintaining the set vehicle speed (divided attention), LODE - creating logical sequences (logical reasoning); WOME - card games (working memory). During every session, each program will be applied for ten minutes, using a 17-inch laptop and a dedicated control panel. The following parameters will be set for SUSA: level up 85% and level down 70%; for LODE: upper threshold 90%, bottom threshold 60%, number of tasks per level 10; for WOME: number of tasks 10, repetitions 1, card display time 2000 ms; for GEAU: upper threshold 95%, bottom threshold 80%; for EINK: upper threshold 90%, bottom threshold 80%, repetitions 1, max time 90/300 s.
Participants will:
The goal of the study is to determine whether applying tDCS before cognitive training improves executive function rehabilitation outcomes and supports the maintenance of these effects over time compared to cognitive training alone.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 120 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Medical University of Lodz is the lead sponsor of 107 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
to tDCS, including:
Implanted electronic devices Metal implants in the head History of seizures Contact allergy to materials used for tDCS stimulation (electrodes)
Withdrawal criteria: participation will be discontinued if any of the following occur:
Urgent medical issues Serious adverse events or side effects Participant unwillingness to continue in the trial
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For the active tDCS condition, a direct current of 2.0 mA will be applied (corresponding to a total charge of 2.4 C, a current density of 0.57 A/m2, and a charge density of 685.7 C/m2), for 20 minutes with ramp-up and ramp-down periods of 20 seconds each.
Procedure: active tDCS
For sham tDCS, the stimulation will utilize the same active tDCS arrangement, with an intensity of 2.0 mA. However, the current will be applied only for the 20 s ramp-up phase at the beginning and the 20 s ramp-down phase at the end of the stimulation. This protocol preserves blinding by mimicking the initial somatosensory sensations typically associated with active tDCS.
Procedure: sham tDCS
For the active tDCS condition, a direct current of 2.0 mA will be applied (corresponding to a total charge of 2.4 C, a current density of 0.57 A/m2, and a charge density of 685.7 C/m2), for 20 minutes with ramp-up and ramp-down periods of 20 seconds each. The tDCS will be administered using a battery-powered direct current stimulator (DC-Stimulator PLUS, neuroCare, Germany) through two saline-soaked sponge electrodes (5 cm × 7 cm). According to the International 10-20 system, the anodal electrodes will be positioned over the left DLPFC on the sites corresponding to F3, whereas the cathodal electrode will be placed above the right DLPFC, corresponding to F4. The electrode locations were verified using a computational brain model. All sessions will be conducted over five consecutive days (from Monday to Friday), with a 24-hour interval between sessions. Each participant will complete a total of 15 treatment sessions with
For sham tDCS, the stimulation will utilize the same active tDCS arrangement, with an intensity of 2.0 mA. However, the current will be applied only for the 20 s ramp-up phase at the beginning and the 20 s ramp-down phase at the end of the stimulation. This protocol preserves blinding by mimicking the initial somatosensory sensations typically associated with active tDCS.
parameters in the Cambridge Neuropsychological Test Automated Battery (CANTAB): DMS; ERT; MTT; OTS; PAL; RTI; RVP; SWM.
The primary outcome of the study is the evaluation of the effect of tDCS intervention on the effectiveness of cognitive function rehabilitation using the RehaCom system in patients with schizophrenia. The scope of these changes will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) (Cambridge Cognition, UK). The CANTAB test will be administered at three time points: before the initiation of the stimulation cycle (V1), immediately after the completion of the three-week rehabilitation program (V2), and eight weeks later (V3) (see Figure 1). The CANTAB scores will be determined using the software. The CANTAB test offers a variety of measures for monitoring cognitive functioning in patients with schizophrenia. The test comes with the CANTAB Connect Research: Admin Application User Guide, which provides information on whether higher scores indicate better ("+ve") or worse ("-ve") performance, or if the interpretation of a measure is more complex ("cx").
Time frame: From enrollment to the end of treatment at 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Dec 2026, 38 months after the start.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 38 months is above that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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