Cognitive ImpairmentsNCT07273175
Effects of Transcranial Direct Current Stimulation on Cognitive Rehabilitation in Schizophrenia
A study testing active tDCS in people with Cognitive Impairments and Schizophrenia, run by Medical University of Lodz at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cognitive Impairments, Schizophrenia
- What is being tested?
- active tDCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2023to 3 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years with schizophrenia diagnosed according to DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
- Ability to provide informed consent for tDCS treatment and use of collected data for research purposes
- Mentally stable, may receive pharmacological treatment
Who cannot join
- Contraindications to tDCS, including:
- Implanted electronic devices Metal implants in the head History of seizures Contact allergy to materials used for tDCS stimulation (electrodes)
- Pregnancy
- Head injury with loss of consciousness or neurosurgery performed within the previous six months
- History of stroke, aneurysm, brain tumor, or other conditions causing increased intracranial pressure
- Migraines
Show all 10Show fewer
- Substance abuse
- Currently receiving electroconvulsive therapy (ECT)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Department of Old Age Psychiatry and Psychotic Disorders
Lodz, Łódź Voivodeship, 92-216
About this study
Official title: Evaluation of the Effects of Transcranial Direct Current Stimulation on the Effectiveness of Cognitive Function Rehabilitation Using the RehaCom System in Patients With Schizophrenia (Study Protocol)
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:
Read more
- Does the combination of active tDCS and RehaCom cognitive training lead to better performance on CANTAB tests compared to training preceded by sham stimulation?
- Does tDCS enhance the effectiveness of cognitive rehabilitation by strengthening neuroplasticity mechanisms? Researchers will compare the group receiving active tDCS + RehaCom with the group undergoing sham stimulation + RehaCom to determine whether active stimulation produces greater improvements in cognitive functioning.
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:
- Undergo assessments at three time points (V1 - baseline, V2 - after 3 weeks of intervention, V3 - after 8 weeks).
- Be evaluated using CANTAB tests, the PANSS and CGI-S scales, and resting-state EEG.
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.
- Conditions
- Cognitive Impairments, Schizophrenia
- Being tested
- active tDCS, sham tDCS
- Keywords
- cognitive impairment, transcranial direct current stimulation, schizophrenia, tDCS, neuromodulation, cognitive remediation therapy, cognitive training, RehaCom
- Medical subject headings
- Cognitive Dysfunction, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tDCSProcedure or surgery
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
sham tDCSProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| real tDCS | Active comparator | 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. Receives: Procedure: active tDCS |
| sham tDCS | Sham comparator | 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. Receives: Procedure: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Oct 2023
- Primary completion3 Dec 2026 (estimated)
- Study completion3 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273175
- Sponsor's protocol ID
- AdriannaSzczakowska-02
- Status last verified
- Jan 2026
- First submitted
- 25 Nov 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Transcranial Direct Current Stimulation on the Effectiveness of Cognitive Function Rehabilitation Using the RehaCom System in Patients With Schizophrenia (Study Protocol)
- ClinicalTrials.gov ID
- NCT07273175
- Acronym / sponsor ID
- AdriannaSzczakowska-02
- Conditions
- Cognitive Impairments, Schizophrenia
- Keywords
- cognitive impairment, transcranial direct current stimulation, schizophrenia, tDCS, neuromodulation, cognitive remediation therapy, cognitive training, RehaCom
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 3 Dec 2026 (estimated)
- Study completion
- 3 Dec 2027 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the combination of active tDCS and RehaCom cognitive training lead to better performance on CANTAB tests compared to training preceded by sham stimulation?
- Does tDCS enhance the effectiveness of cognitive rehabilitation by strengthening neuroplasticity mechanisms? Researchers will compare the group receiving active tDCS + RehaCom with the group undergoing sham stimulation + RehaCom to determine whether active stimulation produces greater improvements in cognitive functioning.
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:
- Undergo assessments at three time points (V1 - baseline, V2 - after 3 weeks of intervention, V3 - after 8 weeks).
- Be evaluated using CANTAB tests, the PANSS and CGI-S scales, and resting-state EEG.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tDCS | Active comparator | Procedure: active tDCSFor 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. |
| sham tDCS | Sham comparator | Procedure: sham tDCSFor 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-65 years with schizophrenia diagnosed according to DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
- Ability to provide informed consent for tDCS treatment and use of collected data for research purposes
- Mentally stable, may receive pharmacological treatment
Key exclusion criteria (10 listed)
- Contraindications to tDCS, including:
- Implanted electronic devices Metal implants in the head History of seizures Contact allergy to materials used for tDCS stimulation (electrodes)
- Pregnancy
- Head injury with loss of consciousness or neurosurgery performed within the previous six months
- History of stroke, aneurysm, brain tumor, or other conditions causing increased intracranial pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active tDCSFor 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 | Procedure or surgery | real tDCS |
| sham tDCSFor 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 or surgery | sham tDCS |
Primary outcome
parameters in the Cambridge Neuropsychological Test Automated Battery (CANTAB): DMS; ERT; MTT; OTS; PAL; RTI; RVP; SWM.
Time frame: From enrollment to the end of treatment at 8 weeks
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").
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS in people with Cognitive Impairments and Schizophrenia, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parameters in the Cambridge Neuropsychological Test Automated Battery (CANTAB): DMS; ERT; MTT; OTS; PAL; RTI; RVP; SWM. (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.