Investigating the Cognitive Source of Visual Working Memory Impairment in Schizophrenia

NCT05496413 | Completed DMC

• 1 other identifier: N202003153
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Memory Deficits Schizophrenia Neurostimulator; Complications

Keywords

schizophrenia

Outcome Measures

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.

  up to one hour

Study Arms (2)

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).

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).

Device: STARSTIM

Interventions

STARSTIM DEVICE

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.

Active comparator Within group; Sham comparator Within group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inform consent acquired
• Age 20 to 65
• Right-handed
• Patients with schizophrenia diagnosed according to DSM-5 criteria

You may not qualify if:

• 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
• Cancer patients
• Patients with high fever
• Patients with significant sensory loss

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead
• Taipei Medical University: collaborator

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

New Taipei City, 231, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Jiunn-Kae Wang, MD, MSc

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending psychiatrist

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: August 11, 2022
• Primary Completion: September 12, 2023
• Study Completion: September 25, 2023
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)