NCT03872310

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

March 11, 2019

Last Update Submit

August 9, 2022

Conditions

Memory DeficitsSchizophreniaNeurostimulator; Complications

Keywords

SchizephreniaCognitive enhancementTranscranial direct current stimulationNon-invasive brain stimulationWorking memory

Outcome Measures

Primary Outcomes (2)

  • 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.

    up to one hour

  • Verbal working memory measured by digit-span test

    The paradigm was also computer-adaptive

    up to one hour

Study Arms (2)

Active comparator

ACTIVE COMPARATOR

Within group

Device: STARSTIM

Sham comparator

SHAM COMPARATOR

Within group

Device: STARSTIM

Interventions

STARSTIMDEVICE

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.

Active comparatorSham comparator

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Inform consent acquired
  • Age 20 to 50
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shuang-Ho Hospital

Taipei, 235, Taiwan

Location

MeSH Terms

Conditions

Memory DisordersSchizophrenia

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Jiunn-Kae Wang, MD

    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 physician of psychiatry department

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 13, 2019

Study Start

May 1, 2019

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)