Memory Deficits Schizophrenia Neurostimulator; ComplicationsNCT05496413
Investigating the Cognitive Source of Visual Working Memory Impairment in Schizophrenia
A study testing STARSTIM in people with Memory Deficits Schizophrenia Neurostimulator; Complications, 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 visual working memory (VWM) 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 65 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
- 31 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Aug 2022to 25 Sep 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inform consent acquired
- Age 20 to 65
- 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
The investigators plan to investigate the effect of enhancement on visual working memory (VWM) in patients of chronic schizophrenia and determine the predictive factors of effective treatment.
Read the detailed description
Schizophrenia is a complex neuro-psychiatric disorder that affects a significant portion of total population worldwide. The disease impairs multiple aspects of human cognition, of which visual working memory (VWM) impairment is known to be one of the pivotal cognitive dysfunction in schizophrenic patients. Despite of several attempts that have been made to establish competent treatment strategies to impede cognitive dysfunction of schizophrenia, till date no such studies exhibited satisfactory outcomes. In this context, numbers of studies have been carried out to utilize transcranial direct current stimulation (tDCS) as a treatment option to enhance working memory deficit in various neuropsychiatric populations, but with very limited success. To this end, the present proposal will focus on the use of transcranial alternating current stimulation (tACS) to better target the oscillatory mechanisms underlying VWM. Our specific aims are twofold, namely, 1) Does DLPFC tACS work on schizophrenic patients in terms of VWM improvement, and 2) how is tACS facilitating patients' VWM? This is because VWM deficit can be caused by poor encoding, poor maintenance, or poor retrieval (or any combination between them). Failure at any of those steps will make the patients appear to have poor VWM from clinical observation, but the cognitive process that is impaired may not be the same across populations.
- Being tested
- STARSTIM
- Keywords
- schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARSTIMDevice
In order to evaluate the working memory ability of schizophrenic participants, a task was designed that needs to be performed by them. Firstly, a stimulus of six different color circles of same size in a gray background would be given for 500ms. This would be followed by 2000ms delay phase and then a test array would be appeared. The test array would be exactly same to the stimulus array but with or without change in color of only one circle. The test array would appear on the screen till the participants record their response and they would be asked to respond if the test array matches to the stimulus or not.
| Study group | Role | What they receive |
|---|---|---|
| Active comparator Within group | Experimental | This project will use the StarStim DC stimulator manufactured by Neuroelectrics that was imported with TFDA approval. At the beginning, the participants would be allowed to perform the task which would be followed by application of tACS. The tACS application would be comprised of sham vs active where the sham condition would be given for 30 seconds while the active session would be applied for 15 mins. In tACS, 1mA of theta (6Hz) tACS would be given at the right F4 and P4 electrodes (5*5 cm2, Sponstim® 25). After tACS, the participants would be asked to perform the same task again and the scores (before and after tACS) will be compared and analyzed statistically. Therefore, each patient will need to participate in 2 sessions (active vs. sham), and they will not know which day is which (randomized order). Receives: Device: STARSTIM |
| Sham comparator Within group | Sham comparator | This project will use the StarStim DC stimulator manufactured by Neuroelectrics that was imported with TFDA approval. At the beginning, the participants would be allowed to perform the task which would be followed by application of tACS. The tACS application would be comprised of sham vs active where the sham condition would be given for 30 seconds while the active session would be applied for 15 mins. In tACS, 1mA of theta (6Hz) tACS would be given at the right F4 and P4 electrodes (5*5 cm2, Sponstim® 25). After tACS, the participants would be asked to perform the same task again and the scores (before and after tACS) will be compared and analyzed statistically. Therefore, each patient will need to participate in 2 sessions (active vs. sham), and they will not know which day is which (randomized order). Receives: Device: STARSTIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
VWM dysfunction
Using the VWM task, investigate at which time point (encoding stage, maintenance stage, or retrieval stage) is VWM dysfunction occurring in schizophrenia patients.
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 posted11 Aug 2022
- Study start11 Aug 2022
- Primary completion12 Sep 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory Deficits Schizophrenia Neurostimulator; ComplicationsStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University
- Responsible party
- Principal investigator, Wang Jiunn-Kae, Taipei Medical University Shuang Ho Hospital
- Investigators
- Jiunn-Kae Wang, MD, MSc, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496413
- Sponsor's protocol ID
- N202003153
- Status last verified
- Sep 2024
- First submitted
- 9 Aug 2022
- Last updated
- 1 Oct 2024
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Cognitive Source of Visual Working Memory Impairment in Schizophrenia
- ClinicalTrials.gov ID
- NCT05496413
- Acronym / sponsor ID
- N202003153
- Keywords
- schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 11 Aug 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 investigators plan to investigate the effect of enhancement on visual working memory (VWM) in patients of chronic schizophrenia and determine the predictive factors of effective treatment.
Detailed description
Schizophrenia is a complex neuro-psychiatric disorder that affects a significant portion of total population worldwide. The disease impairs multiple aspects of human cognition, of which visual working memory (VWM) impairment is known to be one of the pivotal cognitive dysfunction in schizophrenic patients. Despite of several attempts that have been made to establish competent treatment strategies to impede cognitive dysfunction of schizophrenia, till date no such studies exhibited satisfactory outcomes. In this context, numbers of studies have been carried out to utilize transcranial direct current stimulation (tDCS) as a treatment option to enhance working memory deficit in various neuropsychiatric populations, but with very limited success. To this end, the present proposal will focus on the use of transcranial alternating current stimulation (tACS) to better target the oscillatory mechanisms underlying VWM. Our specific aims are twofold, namely, 1) Does DLPFC tACS work on schizophrenic patients in terms of VWM improvement, and 2) how is tACS facilitating patients' VWM? This is because VWM deficit can be caused by poor encoding, poor maintenance, or poor retrieval (or any combination between them). Failure at any of those steps will make the patients appear to have poor VWM from clinical observation, but the cognitive process that is impaired may not be the same across populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active comparator Within group | Experimental | Device: STARSTIMThis project will use the StarStim DC stimulator manufactured by Neuroelectrics that was imported with TFDA approval. At the beginning, the participants would be allowed to perform the task which would be followed by application of tACS. The tACS application would be comprised of sham vs active where the sham condition would be given for 30 seconds while the active session would be applied for 15 mins. In tACS, 1mA of theta (6Hz) tACS would be given at the right F4 and P4 electrodes (5*5 cm2, Sponstim® 25). After tACS, the participants would be asked to perform the same task again and the scores (before and after tACS) will be compared and analyzed statistically. Therefore, each patient will need to participate in 2 sessions (active vs. sham), and they will not know which day is which (randomized order). |
| Sham comparator Within group | Sham comparator | Device: STARSTIMThis project will use the StarStim DC stimulator manufactured by Neuroelectrics that was imported with TFDA approval. At the beginning, the participants would be allowed to perform the task which would be followed by application of tACS. The tACS application would be comprised of sham vs active where the sham condition would be given for 30 seconds while the active session would be applied for 15 mins. In tACS, 1mA of theta (6Hz) tACS would be given at the right F4 and P4 electrodes (5*5 cm2, Sponstim® 25). After tACS, the participants would be asked to perform the same task again and the scores (before and after tACS) will be compared and analyzed statistically. Therefore, each patient will need to participate in 2 sessions (active vs. sham), and they will not know which day is which (randomized order). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inform consent acquired
- Age 20 to 65
- 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 |
|---|---|---|
| STARSTIMIn order to evaluate the working memory ability of schizophrenic participants, a task was designed that needs to be performed by them. Firstly, a stimulus of six different color circles of same size in a gray background would be given for 500ms. This would be followed by 2000ms delay phase and then a test array would be appeared. The test array would be exactly same to the stimulus array but with or without change in color of only one circle. The test array would appear on the screen till the participants record their response and they would be asked to respond if the test array matches to the stimulus or not. | Device | Active comparator Within group, Sham comparator Within group |
Primary outcome
VWM dysfunction
Time frame: up to one hour
Using the VWM task, investigate at which time point (encoding stage, maintenance stage, or retrieval stage) is VWM dysfunction occurring in schizophrenia patients.
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 1 Oct 2024.
- Individual participant dataSharing planned: No
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, MSc 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 Schizophrenia Neurostimulator; Complications, 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 1 Oct 2024. 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?
VWM dysfunction (time frame: up to one hour). 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 1 Oct 2024.