Treatment of cognitive deficit in schizophrenia patients with transcranial direct current stimulation augmented with cognitive training
| ISRCTN | ISRCTN13247154 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13247154 |
| Secondary identifying numbers | CZ.02.1.01/0.0/0.0/16_0250007444 |
- Submission date
- 21/07/2021
- Registration date
- 18/08/2021
- Last edited
- 06/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Schizophrenia is a serious mental illness that affects how a person thinks, feels, and behaves. In recent years, cognitive function impairments have become prominent key symptoms that limit patients' return to normal life. They can include problems with working memory, attention and speech. The effect of antipsychotic medication on cognition improvement is repeatedly being reported as rather low. For this reason, there has been an increased focus on the use of alternative methods. One of these methods is cognitive training, which has repeatedly been found to have a long-term positive effect on cognitive improvement. Other possible treatments include non-invasive neurostimulation methods such as transcranial direct current stimulation (tDCS), which also shows potential effects. This study focuses on the effect of the combination of computer-based cognitive training and tDCS. The combination of those two methods will bring a significantly higher improvement in cognitive performance and reduce the cognitive deficit in schizophrenic patients.
Who can participate?
Adults aged 18-50 years with schizophrenic disorder
What does the study involve?
The participants will undergo an examination at the beginning of the study lead by a doctor-researcher. The examination will involve the assessment of cognitive functions (such as attention and working memory) and current symptoms of the schizophrenic disorder using standardized tests and questionnaires. This will take about one to two hours. The study will assess the effect of a combination of tDCS and cognitive training. The participants will be randomly allocated to one of two groups with either active or placebo (dummy) tDCS stimulation. The cognitive training will be the same for both groups. Application of the tDCS (active/placebo) and cognitive training will occur once daily during the following 5 -15 workdays, each session lasting about 1 hour.
What are the possible benefits and risks of participating?
The possible benefits are the improvement of the cognitive deficit experienced by schizophrenic patients. The study does not include many risks for participants, as cognitive training does not have any clinical risks. tDCS adverse effects include possible short-term temporary itching, tingling or erythema (reddening of the skin) under the electrodes, and other most common adverse effects are headache and fatigue, both of a brief nature. The researchers will take preliminary measures to reduce any of the aforementioned side effects.
Where is the study run from?
National Institute of Mental Health (Czech Republic)
When is the study starting and how long is it expected to run for?
June 2018 to March 2025
Who is funding the study
PharmaBrain (Germany)
Who is the main contact?
Dr Monika Klirova
monika.klirova@nudz.cz
Contact information
Scientific
Topolova 748
Klecany
25067
Czech Republic
 ORCID ID |
0000-0002-8092-9586 |
|---|---|
| Phone | +420 (0)283 088 146 |
| monika.klirova@nudz.cz |
Study information
| Study design | Randomized parallel-group double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Transcranial Direct Current Stimulation (tDCS) in the treatment of cognitive deficit in schizophrenia |
| Study objectives | Cognitive training (CT) and tDCS applied simultaneously will induce a significantly higher improvement in cognitive performance measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) compared to cognitive training (CT) and placebo. |
| Ethics approval(s) | Approved 20/06/2018, National Institute of Mental Health Ethics Committee (Topolova 748, 250 67, Klecany, Czech Republic; +420 (0)283 088 312; ek@nudz.cz), ref: č.j.150/18 |
| Health condition(s) or problem(s) studied | Amelioration of cognitive deficit in schizophrenia |
| Intervention | Patients included in the study will be examined by RBANS to determine cognitive deficit and the current symptom severity is assessed by psychiatric scale (PANSS) at the beginning of the study. Patients will be randomly allocated according to permuted block design to one of two intervention groups: 1. Active anodal tDCS simultaneously with active cognitive training (CT) 2. Active CT and placebo anodal tDCS Each session will be scheduled as follows: CT will last 60 min. tDCS (active or placebo) will last 30 min, applied simultaneously from the beginning of CT. CT will be carried out with the REHACOM program. The HDCStim programmable stimulator (Newronika, Italy) available for a double-blind design will be used for the application of tDCS. Application of the tDCS (active/placebo) and cognitive training will take place once daily during the following 5 -15 workdays, each session lasting for about 1 hour. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | HDCStim programmable stimulator (Newronika, Italy) |
| Primary outcome measure | Cognitive functions assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at baseline, 1-week endpoint and 3-week endpoint |
| Secondary outcome measures | Symptom severity measured by the Positive and Negative Syndrome Scale (PANSS) at baseline, 1-week endpoint and 3-week endpoint |
| Overall study start date | 20/06/2018 |
| Completion date | 31/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Male and female inpatients or outpatients aged 18-50 years 2. Meet ICD-10 criteria for schizophrenia (F20) 3. The mental ability to understand and sign the Informed Consent Form 4. Being on a stable and adequate dose of antipsychotics (monotherapy or combination) for at least two weeks before enrollment and if clinically appropriate to continue on an unchanged dose of antipsychotics during the trial 5. The score for mildly to moderately ill patients in the Positive and Negative Syndrome Scale (PANSS </= 75) at the initial visit |
| Key exclusion criteria | 1. Psychiatric comorbidity on axis I and II according to DSM V in the 6 months before enrollment to the study 2. Contraindications of tDCS (skin disease, superficial injury and fracture or infraction of skull in the stimulation area, epilepsy, metallic plates in the head) 3. Inadequate treatment of psychosis according to recommended guidelines (duration, dose) 4. Pregnancy or breastfeeding 5. Patients with severe and/or unstable somatic disorders (cardiovascular, disease, neoplasms, endocrinology disorders etc) 6. Patients treated with electroconvulsive therapy less than 3 months before enrollment or suffering from neurological disorder (e.g. epilepsy, head trauma with loss of consciousness) 7. Substantial suicidal risk as judged by the treating psychiatrist 8. History of substance-induced disorders in the last year except for nicotine dependency 9. Sensory and motor impairment precluding the participation in CT |
| Date of first enrolment | 01/11/2018 |
| Date of final enrolment | 31/01/2025 |
Locations
Countries of recruitment
- Czech Republic
Study participating centres
Klecany
25067
Czech Republic
Ceske Budejovice
37001
Czech Republic
Prague
18102
Czech Republic
Sponsor information
Research organisation
Topolová 748
Klecany
25067
Czech Republic
| Phone | +420 (0)283 088 111 |
|---|---|
| sekretariat@nudz.cz | |
| Website | https://www.nudz.cz/ |
"ROR" |
https://ror.org/05xj56w78 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Monika Klirova (monika.klirova@nudz.cz). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 05/08/2021 | No | No | ||
| Statistical Analysis Plan | 05/08/2021 | No | No |
Additional files
Editorial Notes
06/03/2025: The total final enrolment was added.
09/10/2024: The following changes were made:
1. The overall study end date was changed from 31/12/2024 to 31/03/2025.
2. The recruitment end date was changed from 31/10/2024 to 31/01/2025.
01/11/2023: Bohnice Psychiatric Hospital was added as a study participating centre.
12/10/2022: The following changes were made and the plain English summary was updated accordingly:
1. The overall trial end date was changed from 31/12/2022 to 31/12/2024.
2. The recruitment end date was changed from 31/10/2022 to 31/10/2024.
3. The intention to publish date was changed from 31/12/2023 to 31/12/2025.
05/08/2021: Trial's existence confirmed by the National Institute of Mental Health Ethics Committee.
