Memory DeficitsCEWMPSNCT03872310
Cognitive Enhancement on Working Memory in Patients With Schizophrenia
A study testing STARSTIM in people with Memory Deficits and Schizophrenia, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
The investigators plan to investigate the effect of enhancement on working memory (WM) in patients of chronic schizophrenia and determine the predictive factors of effective treatment. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Memory Deficits, Schizophrenia, Neurostimulator; Complications
- What is being tested?
- STARSTIM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2019to 30 Aug 2021
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Inform consent acquired
- Age 20 to 50
- Right-handed
- Patients with schizophrenia diagnosed according to DSM-5 criteria
Who cannot join
- Participants who are pregnant or breastfeeding
- Participants who have metal implants
- Participants who have alcohol/substance use disorder or received electro-convulsive therapy within the past 6 months.
- Participants who have history of head injury with loss of consciousness
- Participants who have history of brain lesions, infection, or epilepsy
- Skin lesions on the electrodes placed
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- Cancer patients
- Patients with high fever
- Patients with significant sensory loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Cognitive Enhancement of Transcranial Direct Current Stimulation on Working Memory in Patients With Schizophrenia
The investigators plan to investigate the effect of enhancement on working memory (WM) in patients of chronic schizophrenia and determine the predictive factors of effective treatment.
Read the detailed description
Schizophrenia is a chronic and disabling disease with a prevalence of 0.5%~1.5% in the general population. It's estimated 98% of patients with schizophrenia exhibit variable degrees of cognitive deficits which have been well established to be predictive of patient functioning. A number of treatments had been developed for cognitive enhancement in patients with schizophrenia, nevertheless none of them showed satisfying results.
Transcranial direct current stimulation (tDCS) is a safe and convenient treatment which has showed some evidence of beneficial effects on working memory (WM) in both healthy and neuropsychiatric populations. However, studies of tDCS for cognitive enhancement in patients with schizophrenia are still quiet limited. The results of our previous studies in healthy participants and patients with diabetic polyneuropathy suggest that the anodal tDCS over right dorsolateral prefrontal cortex (DLPFC) improved spatial WM capacity, particularly when task difficulty demands more complex mental manipulations and for the low-performing patients in baseline assessments. Thus, we hypothesize that in the baseline the more severe the patients' cognitive deficit are, the greater their WM capacity improvement would be after applying the anodal Tdcs over right DLPFC.
The investigators plan to recruit 40 patients with chronic schizophrenia. First, the investigators will collect baseline characteristics including disease severity, cognitive deficits and brain connectivity. Then the investigators will adopt a sham-active crossover design for tDCS treatment with the order of the two sessions (sham and active) counterbalanced across participants. The investigators will perform pre- tDCS and post- tDCS assessments of their spatial WM and verbal WM as well as statistical analyses to see if the effect of cognitive enhancement reaches a significant level. In addition, the investigators will explore the possible predictive indicators of effective treatment.
- Being tested
- STARSTIM
- Keywords
- Schizephrenia, Cognitive enhancement, Transcranial direct current stimulation, Non-invasive brain stimulation, Working memory
- Medical subject headings
- Memory Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARSTIMDevice
Right DLPC was located as F4 according to the international 10-20 EEG system. Anodal tDCS was delivered with the anodal pole on the right DLPFCand the cathodal pole on the left cheek of the participant to avoid contaminating other brain regions during electrical stimulation via a pair of rubber electrodes housed in saline-soaked sponge coverings (5x5 cm^2). The direct current was applied with 1.5 mA for 15 min which can facilitate visual short-term memory and create an excitatory effect for up to 90 min. The anodal tDCS stimulated the right DLPC for 15 min with 1.5 mA in active tDCS condition. The sham tDCS condition followed identical tDCS protocol and same 15-min duration except the stimulation time only lasted for the initial 30s so that the participants felt the same initial tingling sensation (if any, only in some participants) but without the actual stimulation. The investigators will perform assessments of adverse effects after each session by a standardized questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Active comparator | Active comparator | Within group Receives: Device: STARSTIM |
| Sham comparator | Sham comparator | Within group Receives: Device: STARSTIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual-spatial working memory span measured by Corsi Block-Tapping task
The paradigm was computer-adaptive, and thus the set size would only increase if the participant passed consecutive two trials of the same span. The lowest span level started from 2 (2 squares that change color) and up to 9 as maximum.
Measured: up to one hour
Verbal working memory measured by digit-span test
The paradigm was also computer-adaptive
Measured: up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 May 2019
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
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 Memory DeficitsStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jiunn-Kae, Taipei Medical University Shuang Ho Hospital
- Investigators
- Jiunn-Kae Wang, MD, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872310
- Sponsor's protocol ID
- N201701040
- Acronym
- CEWMPS
- Status last verified
- Aug 2022
- First submitted
- 11 Mar 2019
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ke SC, Tseng P, Ku HL, Lo YH, Chen YR, Wang JK. Anodal tDCS over right DLPFC does not improve visuospatial working memory in schizophrenia: a single-session, sham-controlled study. BMC Psychiatry. 2026 Apr 25;26(1):458. doi: 10.1186/s12888-026-08107-9.
PubMed 42035044
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Cognitive Enhancement of Transcranial Direct Current Stimulation on Working Memory in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT03872310
- Acronym / sponsor ID
- CEWMPS / N201701040
- Keywords
- Schizephrenia, Cognitive enhancement, Transcranial direct current stimulation, Non-invasive brain stimulation, Working memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 13 Mar 2019 (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 investigators plan to investigate the effect of enhancement on working memory (WM) in patients of chronic schizophrenia and determine the predictive factors of effective treatment.
Detailed description
Schizophrenia is a chronic and disabling disease with a prevalence of 0.5%~1.5% in the general population. It's estimated 98% of patients with schizophrenia exhibit variable degrees of cognitive deficits which have been well established to be predictive of patient functioning. A number of treatments had been developed for cognitive enhancement in patients with schizophrenia, nevertheless none of them showed satisfying results.
Transcranial direct current stimulation (tDCS) is a safe and convenient treatment which has showed some evidence of beneficial effects on working memory (WM) in both healthy and neuropsychiatric populations. However, studies of tDCS for cognitive enhancement in patients with schizophrenia are still quiet limited. The results of our previous studies in healthy participants and patients with diabetic polyneuropathy suggest that the anodal tDCS over right dorsolateral prefrontal cortex (DLPFC) improved spatial WM capacity, particularly when task difficulty demands more complex mental manipulations and for the low-performing patients in baseline assessments. Thus, we hypothesize that in the baseline the more severe the patients' cognitive deficit are, the greater their WM capacity improvement would be after applying the anodal Tdcs over right DLPFC.
The investigators plan to recruit 40 patients with chronic schizophrenia. First, the investigators will collect baseline characteristics including disease severity, cognitive deficits and brain connectivity. Then the investigators will adopt a sham-active crossover design for tDCS treatment with the order of the two sessions (sham and active) counterbalanced across participants. The investigators will perform pre- tDCS and post- tDCS assessments of their spatial WM and verbal WM as well as statistical analyses to see if the effect of cognitive enhancement reaches a significant level. In addition, the investigators will explore the possible predictive indicators of effective treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active comparator | Active comparator | Device: STARSTIMWithin group |
| Sham comparator | Sham comparator | Device: STARSTIMWithin group |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Inform consent acquired
- Age 20 to 50
- Right-handed
- Patients with schizophrenia diagnosed according to DSM-5 criteria
Key exclusion criteria (9 listed)
- Participants who are pregnant or breastfeeding
- Participants who have metal implants
- Participants who have alcohol/substance use disorder or received electro-convulsive therapy within the past 6 months.
- Participants who have history of head injury with loss of consciousness
- Participants who have history of brain lesions, infection, or epilepsy
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 |
|---|---|---|
| STARSTIMRight DLPC was located as F4 according to the international 10-20 EEG system. Anodal tDCS was delivered with the anodal pole on the right DLPFCand the cathodal pole on the left cheek of the participant to avoid contaminating other brain regions during electrical stimulation via a pair of rubber electrodes housed in saline-soaked sponge coverings (5x5 cm^2). The direct current was applied with 1.5 mA for 15 min which can facilitate visual short-term memory and create an excitatory effect for up to 90 min. The anodal tDCS stimulated the right DLPC for 15 min with 1.5 mA in active tDCS condition. The sham tDCS condition followed identical tDCS protocol and same 15-min duration except the stimulation time only lasted for the initial 30s so that the participants felt the same initial tingling sensation (if any, only in some participants) but without the actual stimulation. The investigators will perform assessments of adverse effects after each session by a standardized questionnaire. | Device | Active comparator, Sham comparator |
Primary outcome
Visual-spatial working memory span measured by Corsi Block-Tapping task
Time frame: up to one hour
The paradigm was computer-adaptive, and thus the set size would only increase if the participant passed consecutive two trials of the same span. The lowest span level started from 2 (2 squares that change color) and up to 9 as maximum.
Verbal working memory measured by digit-span test
Time frame: up to one hour
The paradigm was also computer-adaptive
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 11 Aug 2022.
- Derived from this study: PubMed 42035044Ke SC, Tseng P, Ku HL, Lo YH, Chen YR, Wang JK. Anodal tDCS over right DLPFC does not improve visuospatial working memory in schizophrenia: a single-session, sham-controlled study. BMC Psychiatry. 2026 Apr 25;26(1):458. doi: 10.1186/s12888-026-08107-9.
- 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.
Jiunn-Kae Wang, MD principal investigator
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STARSTIM in people with Memory Deficits and Schizophrenia, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 4 inclusion and 9 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 11 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 Taiwan. 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?
Visual-spatial working memory span measured by Corsi Block-Tapping task (time frame: up to one hour). 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?
On the ClinicalTrials.gov record for NCT03872310, 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 11 Aug 2022.