A Randomised Controlled Trial of Concurrent Cognitive Training and Transcranial Direct Current Stimulation or Cognitive Training Alone in Patients With Schizophrenia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Cambridge Neuropsychological Test Automated Battery
研究概览
简要总结
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.
详细描述
The current study is a parallel-group, double-blinded, randomised controlled trial that aimed to fill the knowledge gap in investigating the effect of five sessions of concurrent cognitive training with 'online' tDCS on specific cognitive domains in stable schizophrenia patients at two time-points, (i) immediately after the intervention (ii) at one month after intervention.
It was hypothesized that concurrent cognitive training with 'online' tDCS would result in greater incremental effective improvements in cognitive domains as compared to the cognitive training alone, and the effect would be sustainable at one-month follow-up. The effect of the concurrent cognitive training with 'online' 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.
Participant were randomly allocated to one of the two groups using a predetermined randomisation sequence and block randomisation generator (block of 6). Group 1 received active tDCS stimulation and CT and will be referred to as the active tDCS + CT group. Group 2 received sham tDCS and CT and will be referred to as the sham tDCS + CT group. Both groups consisted of 23 participants and received five treatment sessions on five consecutive days.
Stimulation protocol with the corresponding randomisation code was set up by an independent psychiatrist.The double-blind administration panel of the SatrStim8 system of tDCS ensured effective blinding; both the principal investigator and the participants were blinded to the group allocation until the statistical analysis stage. All outcome measures were assessed at three time-points (T0, baseline; T1, end-treatment course; and T2, at one-month post-intervention).
Declaration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants aged 18-65 years old; and
- •Being right handed; and
- •Able to communicate in Cantonese; and
- •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.
排除标准
- •Significant neurologic history such as dementia, stroke, seizure, Parkinson's disease, multiple sclerosis; or
- •History of brain neurosurgery; or
- •Active abuse of alcohol or illicit substances; or
- •Concurrent use of cognitive-enhancing medications e.g. acetylcholinesterase inhibitors; or
- •Documented history of learning disability; or
- •Implanted with pacemakers, intracranial electrodes, defibrillators, metal implants in head or neck area; or
- •Pregnancy or breastfeeding; or
- •Changes in medication regime over the two weeks before or during the study period (Brunoni, Ferrucci, et al., 2011).
结局指标
主要结局
Cambridge Neuropsychological Test Automated Battery
时间窗: Score change baseline versus post-intervention versus week 4
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.
Trail Making Test, Part A
时间窗: Score change baseline versus post-intervention versus week 4
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).
Backward Digit Span
时间窗: Score change baseline versus post-intervention versus week 4
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.
次要结局
- Positive and Negative Syndrome Scale(Score change baseline versus post-intervention versus week 4)
- Calgary Depression Scale for Schizophrenia (CDSS)(Score change baseline versus post-intervention versus week 4)
- Clinical Global Impression Scale(Score change baseline versus post-intervention versus week 4)
- Social and Occupational Functioning Assessment scale (SOFAS)(Score change baseline versus post-intervention versus week 4)
- World Health Organization Five Well-Being Index (WHO-5)(Score change baseline versus post-intervention versus week 4)
- Ratings on Motivation and Enjoyment on Cognitive Training.(Score change baseline versus post-intervention versus week 4)
- An Adverse Effects Questionnaire(Score change baseline versus post-intervention versus week 4)
- Beck Cognitive Insight Scale Taiwanese Version(Score change baseline versus post-intervention versus week 4)
研究者
CHAN SAU MAN, SANDRA
Associate Professor
Chinese University of Hong Kong