SchizophreniaNCT06155786
Cognitive Effects of tDCS and tRNS in Schizophrenia
A study testing transcranial direct current stimulation (tDCS) active stimulator and transcranial random noise stimulation (tRNS) in people with Schizophrenia and Cognitive Impairment, run by The National Brain Mapping Laboratory (NBML) at 2 sites in Iran.
Trial summary
The purpose of this study is to investigate the cognitive effects of different electrical stimulation modalities, such as transcranial direct and random-noise stimulation over the dorsolateral prefrontal cortex, in schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia, Cognitive Impairment
- What is being tested?
- transcranial direct current stimulation (tDCS) active stimulator and transcranial random noise stimulation (tRNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesIran
- Study dates
- 1 Jan 2023to 22 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia based on Diagnostic and Statistical Manual (DSM)5
- Being 18-50 years old (male and female)
- If female, negative urine pregnancy test
- feasibility for tDCS/tRNS interventions according to safety guidelines
- stable medication regime, especially for classical neuroleptics and all central nervous system activating medications, if taken, 4-6 weeks before the experiment
- fluency in the native language
- right-handed
- Required written informed consent signed by patients' guardian
Who cannot join
- pregnancy
- alcohol or substance dependence
- comorbid bipolar disorder and mood disorder
- history of seizure
- history of neurological disorder
- history of head injury
- Presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Cognitive Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Random Noise Stimulation (tRNS) in Schizophrenia: A Random, Crossover Study
The purpose of this study is to investigate the cognitive effects of different electrical stimulation modalities, such as transcranial direct and random-noise stimulation over the dorsolateral prefrontal cortex, in schizophrenia.
- Conditions
- Schizophrenia, Cognitive Impairment
- Being tested
- transcranial direct current stimulation (tDCS) active stimulator, transcranial random noise stimulation (tRNS), transcranial direct current stimulation (tDCS) sham stimulator
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS) active stimulatorDevice
In tDCS the electrical current is applied directly between electrodes mounted on the head which can can de-or hyperpolarizes resting membrane potential and thereby modulate cortical excitability
transcranial random noise stimulation (tRNS)Device
Here, an alternating electrical current is applied at a mix of frequencies it is called transcranial random noise stimulation (tRNS), which can be delivered in low (between 0.1-100 Hz) or high (between 101-640 Hz) frequency stimulation
transcranial direct current stimulation (tDCS) sham stimulatorDevice
Here a sham electrical current is applied directly between electrodes mounted on the head which can can de-or hyperpolarizes resting membrane potential and thereby modulate cortical excitability
| Study group | Role | What they receive |
|---|---|---|
| tDCS group | Active comparator | In tDCS, direct electrical currents at the intensity of 2 mA are generated by an electrical stimulator and are noninvasively delivered to the left and right dorsolateral prefrontal cortex through a pair of saline-soaked sponge electrodes (7×5 cm) for 30 minutes. Receives: Device: transcranial direct current stimulation (tDCS) active stimulator |
| tRNS group | Active comparator | In tRNS, direct electrical currents at the intensity of 2 mA amplitude (offset at 1 mA) and frequency of 100-640 Hz are generated by an electrical stimulator and are noninvasively delivered to the left and right dorsolateral prefrontal cortex through a pair of saline-soaked sponge electrodes (7×5 cm) for 30 minutes. Receives: Device: transcranial random noise stimulation (tRNS) |
| sham group | Sham comparator | In sham group, placebo stimulation is generated by an electrical stimulator and is noninvasively delivered to the left and right dorsolateral prefrontal cortex through a pair of saline-soaked sponge electrodes (7×5 cm) for 30 minutes. Receives: Device: transcranial direct current stimulation (tDCS) sham stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial Working Memory behavioral performance
The test begins with a number of coloured squares (boxes) shown on the screen. The aim of this test is that by selecting the boxes and using a process of elimination, the participant should find one yellow 'token' in each of a number of boxes and use them to fill up an empty column on the right-hand side of the screen.
Measured: During procedure (4 minutes)
executive function behavioral performance
The participant is shown two displays containing three coloured balls. The test administrator first demonstrates to the participant how to move the balls in the lower display to copy the pattern in the upper display and completes one demonstration problem, where the solution requires one move. The participant must then complete three further problems, one each requiring two moves, three moves, and four moves. Next, the participant is shown further problems and must work out in their head how many moves the solutions require and then select the appropriate box at the bottom of the screen to indicate their response
Measured: During procedure (8-10 minutes)
The Positive and Negative Affect Schedule (PANAS)
The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Measured: through study completion, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Jan 2023
- Primary completion1 Nov 2023
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)
- Sponsor type
- University, hospital or other
- Collaborators
- Leibniz Research Centre for Working Environment and Human Factors, Payame Noor University, RWTH Aachen University
- Responsible party
- Principal investigator, Mohammad Ali Salehinejad, The National Brain Mapping Laboratory (NBML)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155786
- Sponsor's protocol ID
- ifado-PNU
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jafari E, Moghadamzadeh A, Vaziri Z, Atadokht A, Fathi Jouzdani A, Cohen Kadosh R, Nitsche MA, Blumberger DM, Salehinejad MA. Cognitive and emotional effects of bilateral prefrontal anodal tDCS and high-frequency tRNS in schizophrenia: a randomized sham-controlled study. Schizophrenia (Heidelb). 2026 Jan 13;12(1):28. doi: 10.1038/s41537-025-00720-z.
PubMed 41530140
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Random Noise Stimulation (tRNS) in Schizophrenia: A Random, Crossover Study
- ClinicalTrials.gov ID
- NCT06155786
- Acronym / sponsor ID
- ifado-PNU
- Conditions
- Schizophrenia, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)University, hospital or other
- Collaborators
- Leibniz Research Centre for Working Environment and Human Factors, Payame Noor University, RWTH Aachen University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 4 Dec 2023 (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 purpose of this study is to investigate the cognitive effects of different electrical stimulation modalities, such as transcranial direct and random-noise stimulation over the dorsolateral prefrontal cortex, in schizophrenia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS group | Active comparator | Device: transcranial direct current stimulation (tDCS) active stimulatorIn tDCS, direct electrical currents at the intensity of 2 mA are generated by an electrical stimulator and are noninvasively delivered to the left and right dorsolateral prefrontal cortex through a pair of saline-soaked sponge electrodes (7×5 cm) for 30 minutes. |
| tRNS group | Active comparator | Device: transcranial random noise stimulation (tRNS)In tRNS, direct electrical currents at the intensity of 2 mA amplitude (offset at 1 mA) and frequency of 100-640 Hz are generated by an electrical stimulator and are noninvasively delivered to the left and right dorsolateral prefrontal cortex through a pair of saline-soaked sponge electrodes (7×5 cm) for 30 minutes. |
| sham group | Sham comparator | Device: transcranial direct current stimulation (tDCS) sham stimulatorIn sham group, placebo stimulation is generated by an electrical stimulator and is noninvasively delivered to the left and right dorsolateral prefrontal cortex through a pair of saline-soaked sponge electrodes (7×5 cm) for 30 minutes. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Diagnosis of schizophrenia based on Diagnostic and Statistical Manual (DSM)5
- Being 18-50 years old (male and female)
- If female, negative urine pregnancy test
- feasibility for tDCS/tRNS interventions according to safety guidelines
- stable medication regime, especially for classical neuroleptics and all central nervous system activating medications, if taken, 4-6 weeks before the experiment
Key exclusion criteria (7 listed)
- pregnancy
- alcohol or substance dependence
- comorbid bipolar disorder and mood disorder
- history of seizure
- history of neurological disorder
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 |
|---|---|---|
| transcranial direct current stimulation (tDCS) active stimulatorIn tDCS the electrical current is applied directly between electrodes mounted on the head which can can de-or hyperpolarizes resting membrane potential and thereby modulate cortical excitability | Device | tDCS group |
| transcranial random noise stimulation (tRNS)Here, an alternating electrical current is applied at a mix of frequencies it is called transcranial random noise stimulation (tRNS), which can be delivered in low (between 0.1-100 Hz) or high (between 101-640 Hz) frequency stimulation | Device | tRNS group |
| transcranial direct current stimulation (tDCS) sham stimulatorHere a sham electrical current is applied directly between electrodes mounted on the head which can can de-or hyperpolarizes resting membrane potential and thereby modulate cortical excitability | Device | sham group |
Primary outcome
Spatial Working Memory behavioral performance
Time frame: During procedure (4 minutes)
The test begins with a number of coloured squares (boxes) shown on the screen. The aim of this test is that by selecting the boxes and using a process of elimination, the participant should find one yellow 'token' in each of a number of boxes and use them to fill up an empty column on the right-hand side of the screen.
executive function behavioral performance
Time frame: During procedure (8-10 minutes)
The participant is shown two displays containing three coloured balls. The test administrator first demonstrates to the participant how to move the balls in the lower display to copy the pattern in the upper display and completes one demonstration problem, where the solution requires one move. The participant must then complete three further problems, one each requiring two moves, three moves, and four moves. Next, the participant is shown further problems and must work out in their head how many moves the solutions require and then select the appropriate box at the bottom of the screen to indicate their response
The Positive and Negative Affect Schedule (PANAS)
Time frame: through study completion, an average of 3 weeks
The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Results publication: PubMed 41530140Jafari E, Moghadamzadeh A, Vaziri Z, Atadokht A, Fathi Jouzdani A, Cohen Kadosh R, Nitsche MA, Blumberger DM, Salehinejad MA. Cognitive and emotional effects of bilateral prefrontal anodal tDCS and high-frequency tRNS in schizophrenia: a randomized sham-controlled study. Schizophrenia (Heidelb). 2026 Jan 13;12(1):28. doi: 10.1038/s41537-025-00720-z.
- Published resultsLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) active stimulator and transcranial random noise stimulation (tRNS) in people with Schizophrenia and Cognitive Impairment, run by The National Brain Mapping Laboratory (NBML) at 2 sites in Iran.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Spatial Working Memory behavioral performance (time frame: During procedure (4 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06155786, which also lists 1 linked publication.
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 18 Mar 2026.