Schizophrenia Clinical Trial
Official title:
The Effects of Bimodal Anodal Transcranial Direct Current Stimulation Over Bilateral Prefrontal Cortex on Illness Severity, Insight, Functional Outcomes, Quality of Life, Neurocognition and Heart Rate Variability (HRV) in Schizophrenia
Verified date | October 2018 |
Source | Tri-Service General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aimed to investigate the effects of bimodal anodal transcranial direct current stimulation (tDCS) over bilateral dorsolateral prefrontal cortex (DLPFC) on psychopathological symptoms, insight, psychosocial functioning, neurocognitive function and heart rate variability (HRV) in schizophrenia patients
Status | Completed |
Enrollment | 60 |
Est. completion date | September 21, 2018 |
Est. primary completion date | September 21, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Eligible participants aged 20-65 with DSM-IV-TR-defined schizophrenia or schizoaffective disorder. 2. Duration of illness ? 1 year. 3. Being on an adequate therapeutic dose of antipsychotics and clinically stable (nonacute phase of illness) but symptomatic for at least 4 weeks prior to enrolment as defined by Clinical Global Impression-Severity of Illness scale (CGI-S) score ? 4 (at both screening and baseline). 4. Agreement to participate in the study and provide the written informed consent. Exclusion Criteria: 1. Having current psychiatric comorbidity or active substance use disorder, in exception to caffeine and/or tobacco. 2. Having history of seizures. 3. Having contraindications for tDCS, e.g., implanted brain medical devices or metal in the head. 4. Having history of intracranial neoplasms or surgery, or a history of severe head injuries or cerebrovascular diseases. 5. Pregnancy or breastfeeding at enrollment. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Tri-service general hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Tri-Service General Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline scores of Positive and Negative Syndrome Scale (PANSS) at the timepoint immediately after tDCS, at one month and three months after tDCS. | A clinician-administered rating scale to measure the severity of psychopathological symptoms of the patients with schizophrenia spectrum disorder. The patient is rated from 1 to 7 on 30 different symptom items. All items scores are summed up to yield a total PANSS score, which ranges from 30 to 210. A higher score indicates greater psychopathological symptom severity. Then, five main symptom dimension subscales of PANSS can be calculated from 26 of 30 items of PANSS: positive (5 items, score 5-35) , negative (8 items, score 8-56), grandiosity/excitement (4 items, score 4-28), disorganization (5 items, score 5-35), and depression (4 items, score 4-28). | Three months | |
Secondary | Changes from baseline scores at Personal and Social Performance scale (PSP) at the timepoint immediately after tDCS, at one month and three months after tDCS. | A clinician-administered rating scale to measure the psychosocial functioning of the patients with schizophrenia spectrum disorder. The PSP scale measures psychosocial functioning within four domains: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior.The patient is rated from 1 to 6 on each item of the four domains. A higher score indicates greater psychosocial functioning in any of the four domains. The final global score is defined according to a summary instruction table. This scale provides a single, overall rating from 1 to 100, where a higher score represents better personal and social function. | Three months | |
Secondary | Changes from baseline scores of the Global Assessment of Functioning (GAF) Scale of the DSM-IV at the timepoint immediately after tDCS, at one month and three months after tDCS. | GAF is a numeric scale used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of an individual, e.g., how well one is meeting various problems-in-living. Scores range from 100 (extremely high functioning) to 1 (severely impaired). GAF serves as a valid tool of assessing global psychosocial and occupational functioning for schizophrenia patients. | Three months. | |
Secondary | Changes from baseline scores of the Clinical Global Impression (CGI) rating scales at the timepoint immediately after tDCS, at one month and three months after tDCS. | Illness severity was assessed with the Clinical Global Impression (CGI) rating scales. The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The patient is rated from 1 to 7 and a higher score indicates greater illness severity. | Three months. | |
Secondary | Changes from baseline scores of the self-reported version of the graphic personal and social performance scale (SRG-PSP) at the timepoint immediately after tDCS and at one month after tDCS. | The SRG-PSP is a self-rating scale of proven validity and reliability, comprising both male and female versions of cartoon-like pictures that are derived from the narrative text of the four domains of Personal and Social Performance (PSP) scale including the sub-items of socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviour. | One month. | |
Secondary | Changes from baseline scores of the abbreviated version of the Scale to Assess Unawareness in Mental Disorder in schizophrenia (SUMD) at the timepoint immediately after tDCS, at one month and three months after tDCS. | An expert-rating scale based on a patient interview to measure patients' clinical insight. The abbreviated version of SUMD comprises 9 items measuring current states of awareness as follows: (1) a mental disorder, (2) consequences of a mental disorder, (3) effects of drugs, (4) hallucinatory experiences, (5) delusional ideas, (6) disorganized thoughts, (7) blunted affect, (8) anhedonia, and (9) lack of sociability. Scores on each item range from 0 to 3. A score of 0 indicates 'not applicable'; 1, 'aware'; 2, 'somewhat aware/unaware' and 3, 'severely unaware.' Based on the 3 dimensions approach of the abbreviated version of SUMD, the scores on the items 1-3, 4-6 and 7-9 were averaged to obtain the dimension score of 'awareness of the disease', 'awareness of positive symptoms', and 'awareness of negative symptoms', respectively. All dimension scores were linearized on a 0-100 scale, with 0 and 100 indicating the lowest and highest level of unawareness, respectively. | Three months. | |
Secondary | Changes from baseline scores of the Taiwanese version of the Beck Cognitive Insight Scale (BCIS) at the timepoint immediately after tDCS and at one month after tDCS. | Cognitive insight was measured by the Taiwanese version of the Beck Cognitive Insight Scale (BCIS), a self-reported instrument comprising 15 items.The Taiwanese BCIS is composed of 2 subscales including reflective attitude (9 items) and certain attitude (6 items). We obtained a R-C (reflective attitude minus certain attitude) index of the Taiwanese BCIS, representing the measurement of cognitive insight by subtracting the score of the certain attitude subscale from that of the reflective attitude subscale. Lower R-C index scores indicate poorer cognitive insight. | One month. | |
Secondary | Changes from baseline scores of the Taiwanese version of the Self-Appraisal of Illness Questionnaire (SAIQ) at the timepoint immediately after tDCS and at one month after tDCS. | The Taiwanese version of the Self-Appraisal of Illness Questionnaire (SAIQ) was used to assess attitudes toward mental illness and experience of psychiatric treatment.This self-administered tool was composed of 17 items. The patients rated the extent to which they agreed with each statement of the item by using a four-point Likert scale, ranging from 1, ''do not agree at all'', to 4, ''completely agree''. Whether the scale score is in order from least to most or from the most to least depends on the content of the item statement. The total score of SAIQ ranges from 17 to 68. This translated SAIQ comprises a three-factor explanation. The three factors correspond to worry (score 7-28), the need for treatment (score 5-20), and presence/outcome (score 5-20) subscales. Higher SAIQ subscale scores indicate more awareness of mental illness. | One month. | |
Secondary | Changes from baseline scores of the self-administered WHOQOL-BREF at the timepoint immediately after tDCS and at one month after tDCS. | The overall quality of life (QoL) and the specific domains of QoL was measured with the self-administered World Health Organization Questionnaire on Quality of Life: Short Form-Taiwan version (WHOQOL-BREF) which was developed by the WHO in 1998 and was adapted to Taiwan's culture. The WHOQOL-BREF is of well-established validity and reliability, containing 28 five-point Likert items that assessed general (two items) and four specific domains of QoL, including 7 items in physical health, 6 in psychological, 4 in social relationships, and 9 in environmental domains. Higher scores indicate a better QoL. | One month. | |
Secondary | Changes from baseline results of Digit span (forward and backward) at the timepoint immediately after tDCS and at one month after tDCS. | A test to measure the capacity of working memory of the patients. | One month | |
Secondary | Changes from baseline results of Finger tapping test at the timepoint immediately after tDCS and at one month after tDCS. | A neuropsychological test that examines motor functioning, specifically, motor speed and lateralized coordination. | One month | |
Secondary | Changes from baseline results of Continuous Performance (CPT, version 2.0) at the timepoint immediately after tDCS and at one month after tDCS. | A neuropsychological test that examines the performance of prefrontal-mediated task. | One month | |
Secondary | Changes from baseline results of Wisconsin Card Sorting Test (WCST) at the timepoint immediately after tDCS and at one month after tDCS. | A neuropsychological test of "set-shifting", i.e. the ability to display flexibility in the face of changing schedules of reinforcement. | One month. | |
Secondary | Changes from baseline results of Trail Making Test (TMT) at the timepoint immediately after tDCS and at one month after tDCS. | A neuropsychological test of visual attention and task switching. | One month. | |
Secondary | Changes from baseline results of Tower of London test at the timepoint immediately after tDCS and at one month after tDCS. | A neuropsychological test for the assessment of executive functioning specifically to detect deficits in planning, which may occur due to a variety of medical and neuropsychiatric conditions. | One month. | |
Secondary | Changes from baseline heart rate variability (HRV) at the timepoint immediately after tDCS and at one month after tDCS. | An index of autonomic functioning. | One month. | |
Secondary | Changes from baseline scores of the Mini-Mental State Examination (MMSE) at the timepoint immediately after tDCS, at one month and three months after tDCS. | Global cognition was assessed with the Mini-Mental State Examination (MMSE). | Three months. |
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