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Cognitive Enhancement on Working Memory in Patients With Schizophrenia (CEWMPS)

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ClinicalTrials.gov Identifier: NCT03872310
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Wang Jiunn-Kae, Taipei Medical University Shuang Ho Hospital

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.

Condition or disease Intervention/treatment Phase
Memory Deficits Schizophrenia Neurostimulator; Complications Device: STARSTIM Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study of Cognitive Enhancement of Transcranial Direct Current Stimulation on Working Memory in Patients With Schizophrenia
Estimated Study Start Date : March 24, 2019
Estimated Primary Completion Date : March 23, 2020
Estimated Study Completion Date : March 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Schizophrenia

Arm Intervention/treatment
Active Comparator: Active comparator
Within group
Device: STARSTIM
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.

Sham Comparator: Sham comparator
Within group
Device: STARSTIM
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 Measures :
  1. Visual-spatial working memory span measured by Corsi Block-Tapping task [ Time Frame: up to one hour ]
    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.

  2. Verbal working memory measured by digit-span test [ Time Frame: up to one hour ]
    The paradigm was also computer-adaptive



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Inform consent acquired
  2. Age 20 to 50
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872310


Contacts
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Contact: Jiunn-Kae Wang, MD +886970749758 14073@s.tmu.edu.tw

Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Investigators
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Principal Investigator: Jiunn-Kae Wang, MD Taipei Medical University Shuang Ho Hospital

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Responsible Party: Wang Jiunn-Kae, Attending physician of psychiatry department, Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT03872310     History of Changes
Other Study ID Numbers: N201701040
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Wang Jiunn-Kae, Taipei Medical University Shuang Ho Hospital:
Schizephrenia
Cognitive enhancement
Transcranial direct current stimulation
Non-invasive brain stimulation
Working memory
Additional relevant MeSH terms:
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Memory Disorders
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms