Schizophrenia Clinical Trial
Official title:
A Randomised Controlled Trial of Concurrent Cognitive Training and Transcranial Direct Current Stimulation or Cognitive Training Alone in Patients With Schizophrenia.
Verified date | April 2021 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Given the superior effects of CT augmented tDCS in healthy subjects, the aim of the current study was to examine whether the effect of CT on cognition can be enhanced with concurrent anodal tDCS in schizophrenia patients. A double-blinded randomised controlled trial design was utilised and cognitive performances were examined at baseline (T0), immediately after the intervention (T1) and one month post-intervention (T2). It was hypothesized that concurrent CT with tDCS would result in greater and more sustainable cognitive improvement than CT alone because of increased susceptibility to neuroplasticity changes of the underlying activated network (Bikson et al., 2013; Orlov, O'Daly, et al., 2017). The effects of concurrent CT with tDCS were also assessed using blinded assessments of psychotic, negative symptoms, affective symptoms, psychosocial functioning, subjective quality of life (QOL) and tolerability in the two groups.
Status | Completed |
Enrollment | 44 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Participants aged 18-65 years old; and 2. Being right handed; and 3. Able to communicate in Cantonese; and 4. With the diagnosis of schizophrenia meeting the diagnostic criteria of the World Health Organization's 10th version of the International Statistical Classification of Disease and Related Health Problems (ICD-10). All diagnoses were ascertained at multidisciplinary team and endorsed by at least a consultant psychiatrist and a specialist in psychiatry in the clinical teams based in Tai Po Hospital. Exclusion Criteria: 1. Significant neurologic history such as dementia, stroke, seizure, Parkinson's disease, multiple sclerosis; or 2. History of brain neurosurgery; or 3. Active abuse of alcohol or illicit substances; or 4. Concurrent use of cognitive-enhancing medications e.g. acetylcholinesterase inhibitors; or 5. Documented history of learning disability; or 6. Implanted with pacemakers, intracranial electrodes, defibrillators, metal implants in head or neck area; or 7. Pregnancy or breastfeeding; or 8. Changes in medication regime over the two weeks before or during the study period (Brunoni, Ferrucci, et al., 2011). |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Psychiatry, CUHK | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
CHAN SAU MAN, SANDRA |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cambridge Neuropsychological Test Automated Battery | After a first touch screen adaption period, the participants performed four CANTAB tasks always in the same order: Reaction Time (RTI - Simple and Five choice Tone), Paired Associates Learning (PAL - Recommended Standard), Spatial Working Memory (SWM - Recommended Standard 2.0) and Rapid Visual Information Processing (RVP).The key variables from each CANTAB task were selected as the a priori primary measures. | Score change baseline versus post-intervention versus week 4 | |
Primary | Trail Making Test, Part A | Part of the MCCB measure and has a brief administration time, high tolerability, good test-retest reliability and potential changeability in response to pharmacological agents (Nuechterlein et al., 2008). | Score change baseline versus post-intervention versus week 4 | |
Primary | Backward Digit Span | The test was administered according to the instructions provided in the WAIS-IV-HK administration manual. A list of digits at a rate of one per second was read aloud, and the list was repeated in the reverse order to presentation order. All digits must be in the correct order for the list to be marked correct. The list started at a length of two digits, and two lists of each length were read aloud. The maximum span length correctly recalled was selected as the primary measure of the maximum capacity of the participant's working memory. | Score change baseline versus post-intervention versus week 4 | |
Secondary | Positive and Negative Syndrome Scale | It is a 30-item clinician rated questionnaire to assess the symptoms in schizophrenia patient. It has three sub-categories of positive symptoms, negative symptoms and general psychopathology. It is shown to have good construct validity , internal reliability and inter-rater reliability (Lindstrom et al., 1994). It is also shown to be sensitive to change (Santor et al., 2007). Each item is rated on a 7-point scale. Minimum value is 30 and maximum value is 210. Higher score indicates more severe symptoms. | Score change baseline versus post-intervention versus week 4 | |
Secondary | Calgary Depression Scale for Schizophrenia (CDSS) | It is a nine-item clinician rated questionnaire. It is administered following a semi-structured interview. It has been used by other tDCS studies in schizophrenia, and it has been shown to be reliable, valid and sensitive to depressive symptoms separate from positive, negative and extrapyramidal symptoms in schizophrenia. A score above six has 82% specificity and 85% sensitivity for predicting the presence of a major depressive episode | Score change baseline versus post-intervention versus week 4 | |
Secondary | Clinical Global Impression Scale | It is a three-item clinician rated questionnaire to assess illness severity, global improvement or change, and treatment response. Higher scores indicate more severe pathology. The first two items can be rated from 1-7 and the third item consist of a 4×4 rating scale (1-16) that assesses the therapeutic effect of treatment and associated side effects. | Score change baseline versus post-intervention versus week 4 | |
Secondary | Social and Occupational Functioning Assessment scale (SOFAS) | It is a 100-point single-item rating scale to assess patients' personal and social functioning. A score of 0 indicates "Inadequate information". A score of 10 indicates Persistent inability to maintain minimal personal hygiene. Unable to function without harming self or others or without considerable external support (e.g., nursing care and supervision), while a score of 100 indicates superior functioning in a wide range of activities. | Score change baseline versus post-intervention versus week 4 | |
Secondary | World Health Organization Five Well-Being Index (WHO-5) | It is a five-item self-reported questionnaire of subjective quality of life. | Score change baseline versus post-intervention versus week 4 | |
Secondary | Ratings on Motivation and Enjoyment on Cognitive Training. | Visual Analog Scale to rate their motivation and enjoyment to participate in the gamified computerised cognitive training programme (scores ranged from 0-100, with higher scores indicating enhanced enjoyment/ willingness to come). | Score change baseline versus post-intervention versus week 4 | |
Secondary | An Adverse Effects Questionnaire | It is associated with tDCS administration, which has been generated from a systematic review in 2011 by Brunoni. | Score change baseline versus post-intervention versus week 4 | |
Secondary | Beck Cognitive Insight Scale Taiwanese Version | It is 15-tem self-reported questionnaire with two subscales (nine items tapping self-reflectiveness and six on self-certainty). It is shown to have Cronbach's alpha values of >0.70 for both subscales and has moderate stability. | Score change baseline versus post-intervention versus week 4 |
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