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Investigating the Cognitive Source of Visual Working Memory Impairment in Schizophrenia

Primary Purpose

Memory Deficits Schizophrenia Neurostimulator; Complications

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
STARSTIM
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Memory Deficits Schizophrenia Neurostimulator; Complications focused on measuring schizophrenia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  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

Sites / Locations

  • Taipei Medical University Shuang Ho HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active comparator Within group

Sham comparator Within group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2022
Last Updated
August 9, 2022
Sponsor
Taipei Medical University Shuang Ho Hospital
Collaborators
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05496413
Brief Title
Investigating the Cognitive Source of Visual Working Memory Impairment in Schizophrenia
Official Title
Investigating the Cognitive Source of Visual Working Memory Impairment in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2022 (Anticipated)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
Collaborators
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Deficits Schizophrenia Neurostimulator; Complications
Keywords
schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active comparator Within group
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham comparator Within group
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
STARSTIM
Intervention Description
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.
Primary Outcome Measure Information:
Title
VWM dysfunction
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inform consent acquired Age 20 to 65 Right-handed Patients with schizophrenia diagnosed according to DSM-5 criteria Exclusion Criteria: 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
Facility Information:
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
231
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiunn-Kae Wang, M.S.
Phone
=886970749758
Email
wangjk77@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigating the Cognitive Source of Visual Working Memory Impairment in Schizophrenia

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