CClinicalTrials.gg
CompletedNCT05496413Updated Oct 1, 2024

Investigating the Cognitive Source of Visual Working Memory Impairment in Schizophrenia

An interventional study of STARSTIM in Memory Deficits Schizophrenia Neurostimulator; Complications, sponsored by Taipei Medical University Shuang Ho Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-01.

Sponsored by Taipei Medical University Shuang Ho Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Memory Deficits Schizophrenia Neurostimulator; Complications

Keywords

  • schizophrenia
03

In context

Memory Disorders

260 studies on the registry are indexed under Memory Disorders; 60 are open to participants now.

This study's enrollment of 31 is below the median of 73 across 207 interventional studies indexed under Memory Disorders.

Browse Memory Disorders studies →

Lead sponsor

Taipei Medical University Shuang Ho Hospital is the lead sponsor of 100 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Inform consent acquired
  2. Age 20 to 65
  3. Right-handed
  4. Patients with schizophrenia diagnosed according to DSM-5 criteria

Exclusion criteria

Exclusion Criteria:

  1. Participants who are pregnant or breastfeeding
  2. Participants who have metal implants
  3. Participants who have alcohol/substance use disorder or received electro-convulsive therapy within the past 6 months.
  4. Participants who have history of head injury with loss of consciousness
  5. Participants who have history of brain lesions, infection, or epilepsy
  6. Skin lesions on the electrodes placed
  7. Cancer patients
  8. Patients with high fever
  9. Patients with significant sensory loss
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Active comparator Within group

    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).

    Device: STARSTIM

  • Sham comparator
    Sham comparator Within group

    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).

    Device: STARSTIM

Interventions

  • DeviceSTARSTIM

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to one hour

07

Study locations

1 site
  • Taipei Medical University Shuang Ho Hospital
    New Taipei City, 231, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05496413
Lead sponsor
Taipei Medical University Shuang Ho Hospital
Collaborators
Taipei Medical University
Responsible party
Wang Jiunn-Kae (Attending psychiatrist, Taipei Medical University Shuang Ho Hospital) — Principal investigator
First posted
Aug 11, 2022
Start date
Aug 11, 2022
Primary completion
Sep 12, 2023
Completion
Sep 25, 2023
Last update
Oct 1, 2024

Study contacts

Jiunn-Kae Wang, MD, MSc
principal investigator · Taipei Medical University Shuang Ho Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion