The Role of Neuromodulation for Cognitive Processing and Behavioural Inhibition in Gambling Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in scores on the Yale-Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS)
研究概览
简要总结
Gambling disorder is associated to high impulsivity and excessive risk-taking behaviour. These behavioural characteristics related to addiction are linked to cognitive processes in specific brain areas located in the prefrontal cortex (PFC).
With the aim of studying the role of PFC in gambling disorder, the investigators employ transcranial current direct stimulation (tDCS), a noninvasive brain stimulation technique that applies a very weak electrical current to the superficial areas of the brain.
The clinical phase of the research consists on studying the effects of tDCS in combination with cognitive behavioural therapy (CBT) in patients that attend the United Kingdom (UK) National Problem Gambling Clinic. The main objective of the project is to investigate whether the combination of tDCS and CBT can help to decrease impulsivity and risk-taking behaviour and therefore improve the treatment for gambling disorder.
详细描述
The investigators aim to have a total of 32 participants diagnosed with gambling disorder with the Problem Gambling Severity Index (PGSI). There will be 16 participants per group having two different groups (real stimulation and sham). Real stimulation involves the application of tDCS stimulation and sham condition is used as a control (similar to a placebo).
Participants will attend 8 weekly sessions where they receive tDCS stimulation for 20 minutes, while complete CANTAB cognitive tasks that measure cognitive processes such us control inhibition and risk-taking behaviour. Electroencephalography (EEG) activity will be measured before and after tDCS.
Participants will also complete cognitive questionnaires (Pathological Gambling adapted Yale-Brown Obsessive Compulsive Scale (PG-YBOCS), Gambling Symptom Assessment Scale (G-SAS) and Visual Analogue Scale (VAS) for gambling cravings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants will be allocated either to a tDCS Stimulation condition or to a tDCS Sham condition. Neither the investigator nor the participant will know to which condition the participant has been allocated.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or females between 18-65 years old diagnosed with disordered gambling based on the Problem Gambling Severity Index (PGSI) who can speak and read English and don't have any of the exclusion criteria.
排除标准
- •History or evidence of chronic or residual neurological disease.
- •A pacemaker or deep brain stimulation.
- •Metal implants in head or neck area (e.g. postoperative clips after intracerebral aneurysm; arterial aneurysm in the vascular system, implantation of an artificial hearing aid).
- •Intracerebral ischemia/history of bleeding.
- •Prior evidence of epileptic seizures, history of epilepsy.
- •History of head injury with loss of consciousness.
- •Any serious medical conditions (disease of the internal organs).
- •Pregnancy or breast-feeding.
- •Negative prescreening from the clinic psychiatrist.
研究组 & 干预措施
Real Stimulation tDCS with CBT
16 participants will attend to one weekly tDCS stimulation session with intensity 1.8 milliamps for 8 consecutive weeks. Following the tDCS session, participants will attend to a cognitive behavioural therapy (CBT) session. One tDCS + CBT session per week (Total: 8 sessions).
干预措施: Transcranial direct current stimulation (tDCS) (Device)
Real Stimulation tDCS with CBT
16 participants will attend to one weekly tDCS stimulation session with intensity 1.8 milliamps for 8 consecutive weeks. Following the tDCS session, participants will attend to a cognitive behavioural therapy (CBT) session. One tDCS + CBT session per week (Total: 8 sessions).
干预措施: Cognitive Behavioural Therapy (CBT) (Behavioral)
Sham tDCS with CBT
16 participants will attend to one weekly Sham tDCS session with intensity 0 milliamps for 8 consecutive weeks. Following the Sham tDCS session, participants will attend to a CBT session. One Sham tDCS + CBT session per week (Total: 8 sessions).
干预措施: Transcranial direct current stimulation (tDCS) (Device)
Sham tDCS with CBT
16 participants will attend to one weekly Sham tDCS session with intensity 0 milliamps for 8 consecutive weeks. Following the Sham tDCS session, participants will attend to a CBT session. One Sham tDCS + CBT session per week (Total: 8 sessions).
干预措施: Cognitive Behavioural Therapy (CBT) (Behavioral)
结局指标
主要结局
Change in scores on the Yale-Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS)
时间窗: Change from baseline PG-YBOCS scores at week 2, 3, 4, 5, 6, 7 and 8
It is a 10-item questionnaire that measures the gambling severity. The scores range from 0 to 4 in each question and the total score ranges from 0 to 40. The questions 1 to 5 assess urges and thoughts associated with gambling disorder, and the rest assess the behavioral component of the disorder. The total score will be calculated as well as the separate scores. Gambling severity will be higher with higher PG-YBOCS scores.
Change in scores on the Visual Analogue Scale (VAS)
时间窗: Change from baseline VAS scores at week 2, 3, 4, 5, 6, 7 and 8
It is a horizontal line which length is 100 mm where the left side corresponds to the lower scores and the right side to the highest scores (it ranges from 0 to 10). The participant will draw a line where the level best represents their gambling cravings at the current time. The score will be calculated by measuring this line (in millimetres). The gambling cravings will be higher with higher VAS scores.
Change in scores on the Gambling Symptom Assessment Scale (G-SAS)
时间窗: Change from baseline G-SAS scores at week 8
It is a 12-item scale to measure gambling symptoms. Each of the 12 questions has a score ranging from 0 to 4 based on the last week. It is useful to measure changes during treatment. The total score ranges from 0 to 48. The symptoms severity will be higher with higher G-SAS scores.
Change in scores on the Cambridge Gambling Task (CGT)
时间窗: Change from baseline CGT scores at week 8
Measures of gambling behaviour.
次要结局
- Change in encephalography (EEG) activity(Change from baseline EEG activity in weeks 1, 2, 3, 4, 5, 6, 7 and 8)
- Change in scores on the Information Sampling Task (IST)(Change from baseline IST scores at week 2, 3, 4, 5, 6, 7 and 8)
- Change in scores on the Stop Signal Task (SST)(Change from baseline IST scores at week 2, 3, 4, 5, 6, 7 and 8)
研究者
Elena Gomis Vicent
Principal Investigator
University of East London