SchizophreniaPhase 1NCT05342727
Transcranial Direct and Alternating Stimulation of the Prefrontal Cortex for Cognitive Improvement in Schizophrenia
A Phase 1 study testing transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) in people with Schizophrenia and Cognitive Dysfunction, run by The National Brain Mapping Laboratory (NBML) at 1 site in Iran.
Trial summary
The purpose of this study is to investigate different stimulation intensities and frequencies of transcranial direct and alternating current stimulation over the dorsolateral prefrontal cortex for cognitive improvement in schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia, Cognitive Dysfunction
- What is being tested?
- transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 1 Apr 2021to 31 Jul 2022
- Phase
- Phase 1
- 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 DSM V,
- Being 18-50 years old (male and female)
- If female, negative urine pregnancy test
- feasibility for tDCS interventions according to safety guidelines
- stable medication regime especially the classical neuroleptics and all CNS-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
- 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) or fear of enclosed spaces).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Transcranial Direct and Alternating Stimulation of the Prefrontal Cortex at Different Intensities and Frequencies on Cognition of Schizophrenic Patients
The purpose of this study is to investigate different stimulation intensities and frequencies of transcranial direct and alternating current stimulation over the dorsolateral prefrontal cortex for cognitive improvement in schizophrenia.
Read the detailed description
In this randomized, double-blind study, 50 patients diagnosed with schizophrenia are randomly assigned into two arms. The first group receives transcranial direct current stimulation (tDCS) at three intensities (2 mA, 3 mA, and sham) and the second group receives transcranial alternating current stimulation (tACS) at three different frequencies (8 Hz, 40 Hz, and sham) over the left dorsolateral prefrontal cortex for 20 min. There are at least 72 hours between stimulation sessions. The patients conduct three cognitive tasks from the CANTAB neuropsychological battery for schizophrenia during stimulation including a working memory task, a cognitive flexibility task, and an emotion recognition task. Mood stability is also evaluated before and after each stimulation session with the Positive and Negative Affect Scale (PANAS).
- Conditions
- Schizophrenia, Cognitive Dysfunction
- Being tested
- transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS)
- Keywords
- schizophrenia, tDCS, tACS, Cognition, dorsolateral prefrontal cortex
- 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)Device
In tDCS, direct electrical currents at the intensity of interest (2 mA for example) are generated by an electrical stimulator and are noninvasively delivered to the scalp through a pair of saline-soaked sponge electrodes (7×5 cm).
transcranial alternating current stimulation (tACS)Device
In tACS, alternating electrical currents at the frequency of interest (8 Hz for example) are generated by an electrical stimulator and are noninvasively delivered to the scalp through a pair of saline-soaked sponge electrodes (7×5 cm).
| Study group | Role | What they receive |
|---|---|---|
| tDCS group | Active comparator | The tDCS arm receives two real (or active) stimulation at 2 mA and 3 mA intensities and one placebo electrical stimulation for 20 minutes. Receives: Device: transcranial direct current stimulation (tDCS) |
| tACS group | Active comparator | The tACS arm receives two real (or active) stimulation at 8 Hz and 40 Hz frequencies and one placebo alternating electrical stimulation for 20 minutes. Receives: Device: transcranial alternating current stimulation (tACS) |
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)
Emotional recognition behavioral performance
Computer-morphed images derived from the facial features of real individuals, each showing a specific emotion, are displayed on the screen, one at a time. Each face is displayed for 200 milliseconds and then immediately covered up to prevent residual processing of the image. The participant must select which emotion the face displayed from 6 options (sadness, happiness, fear, anger, disgust or surprise)
Measured: During procedure (60 minutes)
Secondary outcomes (1)
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 in each experimental session up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Apr 2021
- Primary completion15 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group and each group with crossover design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)
- Sponsor type
- University, hospital or other
- Collaborators
- Ardabil University of Medical Sciences, Leibniz Research Centre for Working Environment and Human Factors
- Responsible party
- Principal investigator, Mohammad Ali Salehinejad, The National Brain Mapping Laboratory (NBML)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342727
- Sponsor's protocol ID
- IR.ARUMS.REC.1400.043
- Status last verified
- Aug 2022
- First submitted
- 26 Mar 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon reasonable request from the PI after publication of results
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Transcranial Direct and Alternating Stimulation of the Prefrontal Cortex at Different Intensities and Frequencies on Cognition of Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT05342727
- Acronym / sponsor ID
- IR.ARUMS.REC.1400.043
- Conditions
- Schizophrenia, Cognitive Dysfunction
- Keywords
- schizophrenia, tDCS, tACS, Cognition, dorsolateral prefrontal cortex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)University, hospital or other
- Collaborators
- Ardabil University of Medical Sciences, Leibniz Research Centre for Working Environment and Human Factors
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 25 Apr 2022 (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 different stimulation intensities and frequencies of transcranial direct and alternating current stimulation over the dorsolateral prefrontal cortex for cognitive improvement in schizophrenia.
Detailed description
In this randomized, double-blind study, 50 patients diagnosed with schizophrenia are randomly assigned into two arms. The first group receives transcranial direct current stimulation (tDCS) at three intensities (2 mA, 3 mA, and sham) and the second group receives transcranial alternating current stimulation (tACS) at three different frequencies (8 Hz, 40 Hz, and sham) over the left dorsolateral prefrontal cortex for 20 min. There are at least 72 hours between stimulation sessions. The patients conduct three cognitive tasks from the CANTAB neuropsychological battery for schizophrenia during stimulation including a working memory task, a cognitive flexibility task, and an emotion recognition task. Mood stability is also evaluated before and after each stimulation session with the Positive and Negative Affect Scale (PANAS).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group and each group with crossover design
| Arm | Type | Receives |
|---|---|---|
| tDCS group | Active comparator | Device: transcranial direct current stimulation (tDCS)The tDCS arm receives two real (or active) stimulation at 2 mA and 3 mA intensities and one placebo electrical stimulation for 20 minutes. |
| tACS group | Active comparator | Device: transcranial alternating current stimulation (tACS)The tACS arm receives two real (or active) stimulation at 8 Hz and 40 Hz frequencies and one placebo alternating electrical stimulation for 20 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 DSM V,
- Being 18-50 years old (male and female)
- If female, negative urine pregnancy test
- feasibility for tDCS interventions according to safety guidelines
- stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment
Key exclusion criteria (6 listed)
- pregnancy
- alcohol or substance dependence
- history of seizure
- history of neurological disorder
- history of head injury
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)In tDCS, direct electrical currents at the intensity of interest (2 mA for example) are generated by an electrical stimulator and are noninvasively delivered to the scalp through a pair of saline-soaked sponge electrodes (7×5 cm). | Device | tDCS group |
| transcranial alternating current stimulation (tACS)In tACS, alternating electrical currents at the frequency of interest (8 Hz for example) are generated by an electrical stimulator and are noninvasively delivered to the scalp through a pair of saline-soaked sponge electrodes (7×5 cm). | Device | tACS 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
Emotional recognition behavioral performance
Time frame: During procedure (60 minutes)
Computer-morphed images derived from the facial features of real individuals, each showing a specific emotion, are displayed on the screen, one at a time. Each face is displayed for 200 milliseconds and then immediately covered up to prevent residual processing of the image. The participant must select which emotion the face displayed from 6 options (sadness, happiness, fear, anger, disgust or surprise)
1 secondary outcome
The Positive and Negative Affect Schedule (PANAS)
Time frame: through study completion in each experimental session up to 1 hour
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 8 Aug 2022.
- Individual participant dataSharing planned: No. Data will be available upon reasonable request from the PI after publication of results
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) in people with Schizophrenia and Cognitive Dysfunction, run by The National Brain Mapping Laboratory (NBML) at 1 site 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 6 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 8 Aug 2022. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 8 Aug 2022.