SchizophreniaPhase 1NCT05200962
Electrical Brain Stimulation for Cognitive Impairment in Schizophrenia: a tDCS-fMRI Study
A Phase 1 study testing transcranial direct current stimulation in people with Schizophrenia and Cognitive Impairment, run by The National Brain Mapping Laboratory (NBML) at 1 site in Iran.
Trial summary
The purpose of this study is to investigate the mechanism of action of transcranial electrical brain stimulation over the dorsolateral prefrontal cortex for cognitive impairment 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 1 Feb 2022to 1 Aug 2024
- 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
- men or women (18-50 yrs old) with a DSM 5 SCZ diagnosis,
- If female, negative urine pregnancy test
- significant cognitive impairment (1 SD below the norm on the working memory/executive functioning task performance)
- 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
- ability to provide informed consent.
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 MRI 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). Eligibility will be determined by the "MRI Safety Screening Questionnaire" and verified, if necessary, by a radiology consultant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Mechanism of Action of Electrical Brain Stimulation for Cognitive Impairment in Schizophrenia: a tDCS-fMRI Study
The purpose of this study is to investigate the mechanism of action of transcranial electrical brain stimulation over the dorsolateral prefrontal cortex for cognitive impairment in schizophrenia. To do so the effect of a 3-mA stimulation protocol on neurocognitive functions will be investigated using behavioral performance and fMRI.
Read the detailed description
Thirty schizophrenic patients will be recruited after meeting the inclusion criteria and will be randomly assigned to active and sham stimulation groups. A single session of concurrent prefrontal tDCS/fMRI will be conducted. Participants will undergo baseline task performance before the intervention. One week later, they will undergo the tDCS intervention (active or sham) next to the scanner during which they perform the working memory task varying in cognitive load. They will perform the task 24 h later again. They will be then transferred to MRI scanner right after stimulation
- Conditions
- Schizophrenia, Cognitive Impairment
- Being tested
- transcranial direct current stimulation
- Keywords
- Schizophrenia, cognitive impairment, Transcranial direct current stimulation, fMRI
- 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 stimulationDevice
Also called tDCS, tES
In tDCS, direct electrical currents 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 |
|---|---|---|
| Active tDCS group | Experimental | The experimental arm receives real (or active) electrical stimulation for 20 minutes Receives: Device: transcranial direct current stimulation |
| sham tDCS group | Sham comparator | The sham arm receives sham (or no real) intervention in which stimulation lasts for 30 seconds and ends afterward. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working memory behavioral performance
A computerized version of 3- back letter task, optimized for administration in a functional MRI environment will be employed during the experiment
Measured: up to 24 hours after the intervention
Modifications to blood-oxygen-level-dependent (BOLD) signal
Changes to blood-oxygen-level-dependent (BOLD) signal (arbitrary units) of brain areas that are implicated in cognitive impairment and pathophysiology of schizophrenia during the working memory task, as measured by fMRI following the intervention between the active and sham groups.
Measured: 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 posted21 Jan 2022
- Study start1 Feb 2022
- Primary completion30 May 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Ruhr University of Bochum, Leibniz Research Centre for Working Environment and Human Factors, University of Tehran
- Responsible party
- Principal investigator, Mohammad Ali Salehinejad, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200962
- Sponsor's protocol ID
- 2021_01_GF16
- Status last verified
- Nov 2023
- First submitted
- 22 Dec 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Mechanism of Action of Electrical Brain Stimulation for Cognitive Impairment in Schizophrenia: a tDCS-fMRI Study
- ClinicalTrials.gov ID
- NCT05200962
- Acronym / sponsor ID
- 2021_01_GF16
- Conditions
- Schizophrenia, Cognitive Impairment
- Keywords
- Schizophrenia, cognitive impairment, Transcranial direct current stimulation, fMRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)University, hospital or other
- Collaborators
- University of British Columbia, Ruhr University of Bochum, Leibniz Research Centre for Working Environment and Human Factors, University of Tehran
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 21 Jan 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 the mechanism of action of transcranial electrical brain stimulation over the dorsolateral prefrontal cortex for cognitive impairment in schizophrenia. To do so the effect of a 3-mA stimulation protocol on neurocognitive functions will be investigated using behavioral performance and fMRI.
Detailed description
Thirty schizophrenic patients will be recruited after meeting the inclusion criteria and will be randomly assigned to active and sham stimulation groups. A single session of concurrent prefrontal tDCS/fMRI will be conducted. Participants will undergo baseline task performance before the intervention. One week later, they will undergo the tDCS intervention (active or sham) next to the scanner during which they perform the working memory task varying in cognitive load. They will perform the task 24 h later again. They will be then transferred to MRI scanner right after stimulation
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS group | Experimental | Device: transcranial direct current stimulationThe experimental arm receives real (or active) electrical stimulation for 20 minutes |
| sham tDCS group | Sham comparator | Device: transcranial direct current stimulationThe sham arm receives sham (or no real) intervention in which stimulation lasts for 30 seconds and ends afterward. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- men or women (18-50 yrs old) with a DSM 5 SCZ diagnosis,
- If female, negative urine pregnancy test
- significant cognitive impairment (1 SD below the norm on the working memory/executive functioning task performance)
- 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 stimulationAlso: tDCS, tESIn tDCS, direct electrical currents 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 | Active tDCS group, sham tDCS group |
Primary outcome
Working memory behavioral performance
Time frame: up to 24 hours after the intervention
A computerized version of 3- back letter task, optimized for administration in a functional MRI environment will be employed during the experiment
Modifications to blood-oxygen-level-dependent (BOLD) signal
Time frame: up to 1 hour
Changes to blood-oxygen-level-dependent (BOLD) signal (arbitrary units) of brain areas that are implicated in cognitive impairment and pathophysiology of schizophrenia during the working memory task, as measured by fMRI following the intervention between the active and sham groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- 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.
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 in people with Schizophrenia and Cognitive Impairment, 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. 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. 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.
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?
Results are not available in the source record.
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?
Working memory behavioral performance (time frame: up to 24 hours after the intervention). The study lists 2 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 13 Nov 2023.