Non-invasive Brain Stimulation of the Prefrontal Cortex in Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Abstinence
研究概览
简要总结
Every year, alcohol causes 3 million deaths worldwide. Even though a lot of treatments already exist, many of them are characterized by a high percentage of drop-out or relapse. Transcranial direct current stimulation (tDCS), a NIBS, is receiving increased attention as a possible new addiction treatment. However, little consensus exists in the concrete parameters (e.g. montage, current, intensity). Moreover, a lot of tDCS research focuses on subjective outcomes, like the report of craving, which are more prone to different biases and fluctuations. In this study, we aim to investigate the effect of HD-tDCS, a more focal stimulation variant, on AUDs. Using this intervention, stimulation can be restricted to one hemisphere, controlling for possible inhibition effects of the cathode. A between-subject design will be carried out, including patients with an AUD. Participants will receive 5 sessions of either real or sham right anodal HD-tDCS over the dorsolateral prefrontal cortex (dlPFC). Craving will be accounted for at baseline and after every stimulation session. Moreover, we will measure the activity of the brain in rest and during two inhibition tasks (Go/NoGo and cue reactivity task). This objective measure will be carried out both before (baseline) and at two time points after the stimulation, to measure effects on both the short and longer term. One month after the intervention, abstinence will be checked through a follow-up phone call. Through this study, we aim to describe positive effects of right dlPFC stimulation on craving, abstinence, and EEG measures.
详细描述
Population
This study will focus on patients with AUD, as these are the easiest to recruit. Participants in this study will be enrolled in a residential SUD treatment or a day hospital SUD treatment. As such, medical supervision can be guaranteed. In addition, sobriety is assessed objectively and routinely as part of TAU, enabling exclusion of patients under influence of alcohol. Cognitive impairment will be assessed using the MoCA and participants with a score below 10 (severe cognitive impairment) will be excluded.
Design
This study will use a between-subjects design. The experiment will be conducted double-blind to minimalize placebo effects and researcher bias. Group allocation will be conducted semi-randomly, with matching of participants' sex. The otherwise identical placebo protocol features sham stimulation (after a short ramp up, current drops again). The short ramp up is used to induce the same sensations as in the stimulation group (possible itching and tingling).
Measures
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, Outcomes Assessor)
盲法说明
Double blind: another researcher than the one collecting data will program the codes of the ad verum vs. sham stimulation so that both participant and researcher (collecting data) are blinded
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
- •DSM-V criteria for alohol use disorder
- •dutch speaking
- •18-65 years old
- •abstinence in the past 10 days
排除标准
- •diagnosis or family history of epilepsy
- •a history of severe brain injury
- •a cardiac pacemaker or electronic implants
- •a scalp skin condition
- •pregnancy
- •concurrent treatment with benzodiazepines
- •hairstyle incompatible with EEG-measurements
- •a psychotic disorder or neurological disease
- •severe cognitive impairment defined as a score lower than 10 on the Montreal Cognitive Assessment (MoCA).
结局指标
主要结局
Abstinence
时间窗: 1 month after the intervention
1 month after the last stimulation session, verbally self-reported abstinence status will be registered. To do so the Quick Drinking Screen (QDS) will be used during a phone call by the researcher.
次要结局
- ERP measures(Total estimated period of one week: pre-intervention (on day 1;T1), after a first stimulation session (day 1, 30 minutes after T1) and after the full intervention of 5 sessions (on day 5,4 days after T1))
- Effortful control scale (EC)(The week before first day of intervention (T1), during a block of questionnaires (estimated at 1 hour in time spending))
- Alcohol Use Disorders Identification Test (AUDIT)(The week before first day of intervention (T1), during a block of questionnaires (estimated at 1 hour in time spending))
- screening alcohol preference(The week before first day of intervention (T1), during a block of questionnaires (estimated at 1 hour in time spending))
- Craving measures(Total estimated period of one week: measure pre-intervention (day 1, T1) and after every stimulation session (T1 + 1 hour, T1 + 1 day, T1 + 2 days, T1 + 3 days and T1+ 4 days))
- resting state EEG in alpha band(otal estimated period of one week: pre-intervention (on day 1;T1), after a first stimulation session (day 1, 30 minutes after T1) and after the full intervention of 5 sessions (on day 5,4 days after T1))
- Beck Depression Inventory (BDI)(The week before first day of intervention (T1) and after intervention (T2))
- Behavioral inhibition system/behavioral approach system (BIS/BAS) Scale(The week before first day of intervention (T1), during a block of questionnaires (estimated at 1 hour in time spending))
- Montreal Cognitive Assessment (MoCA)(The week before first day of intervention (T1), during a block of questionnaires (estimated at 1 hour in time spending))
- Barratt Impulsivity Scale (BIS)(The week before first day of intervention (T1), during a block of questionnaires (estimated at 1 hour in time spending))