Cognitive Enhancement on Working Memory in Patients With Schizophrenia (CEWMPS)
Primary Purpose
Memory Deficits, Schizophrenia, Neurostimulator; Complications
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
STARSTIM
Sponsored by
About this trial
This is an interventional treatment trial for Memory Deficits focused on measuring Schizephrenia, Cognitive enhancement, Transcranial direct current stimulation, Non-invasive brain stimulation, Working memory
Eligibility Criteria
Inclusion criteria
- Inform consent acquired
- Age 20 to 50
- 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
Sites / Locations
- Shuang-Ho Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active comparator
Sham comparator
Arm Description
Within group
Within group
Outcomes
Primary Outcome Measures
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.
Verbal working memory measured by digit-span test
The paradigm was also computer-adaptive
Secondary Outcome Measures
Full Information
NCT ID
NCT03872310
First Posted
March 11, 2019
Last Updated
August 9, 2022
Sponsor
Taipei Medical University Shuang Ho Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03872310
Brief Title
Cognitive Enhancement on Working Memory in Patients With Schizophrenia
Acronym
CEWMPS
Official Title
A Study of Cognitive Enhancement of Transcranial Direct Current Stimulation on Working Memory in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
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
Schizephrenia, Cognitive enhancement, Transcranial direct current stimulation, Non-invasive brain stimulation, Working memory
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active comparator
Arm Type
Active Comparator
Arm Description
Within group
Arm Title
Sham comparator
Arm Type
Sham Comparator
Arm Description
Within group
Intervention Type
Device
Intervention Name(s)
STARSTIM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual-spatial working memory span measured by Corsi Block-Tapping task
Description
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.
Time Frame
up to one hour
Title
Verbal working memory measured by digit-span test
Description
The paradigm was also computer-adaptive
Time Frame
up to one hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Inform consent acquired
Age 20 to 50
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiunn-Kae Wang, MD
Organizational Affiliation
Taipei Medical University Shuang Ho Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shuang-Ho Hospital
City
Taipei
ZIP/Postal Code
235
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive Enhancement on Working Memory in Patients With Schizophrenia
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