Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Difference in Timeline Followback Questionnaire abstinence period length
研究概览
简要总结
The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcranial direct current stimulation (tDCS) for new treatments for alcohol use disorder (AUD) that support long-term abstinence. This study will allow the investigators to discern whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can lead to improved treatment outcomes as it pertains to executive functioning and maintenance of abstinence. This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease relapse probability in addiction. The long-term goal is to develop new addiction treatments that support long-term abstinence. The exploratory goal of this research is to associate genotypes and epigenetic changes with variations in intervention response and clinical outcome. Individual differences in baseline genetic profiles or epigenetic changes over the course of treatment could be associated with treatment response variability.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Meet the Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for AUD
- •Abstinent from alcohol use
- •Must have the intention to remain in the Lodging Plus program until the end of the intervention portion of the study.
排除标准
- •Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness>30 min, HIV)
- •A head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
- •Any contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
- •Any primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder); Participants with other treated and stable psychiatric disorders will be included
- •Presence of a condition that would render study measures difficult or impossible to administer or interpret
- •Primary current substance use disorder diagnosis on a substance other than alcohol except for caffeine or nicotine
- •Clinical evidence for Wernicke-Korsakoff syndrome
- •Left-handedness
- •Entrance to the treatment program under a court mandate
结局指标
主要结局
Difference in Timeline Followback Questionnaire abstinence period length
时间窗: Up to 4 months post-intervention
The Timeline Followback Questionnaire will be used to assess length of abstinence period measured in days at 1, 2, 3 and 4 months over the follow-up period. This is a measure of feasibility.
Change in D-KEFS Trail Making (1-5) score
时间窗: Up to 4 months post-intervention
The D-KEFS Trail Making (1-5) assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the D-KEFS Trail Making score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Difference in Timeline Followback Questionnaire relapse rates
时间窗: Up to 4 months post-intervention
The Timeline Followback Questionnaire will be used to assess relapse status as a binary, (has or has not relapsed), at 1, 2, 3, and 4 months over the follow-up period. This is a measure of feasibility.
Change in D-KEFS Verbal Frequency score
时间窗: Up to 4 months post-intervention
The D-KEFS Verbal Frequency assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the D-KEFS Verbal Frequency score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Change in Digit Symbol (WAIS IV) score
时间窗: Up to 4 months post-intervention
The Digit Symbol (WAIS IV) assessment, also known as Coding, will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the Digit Symbol (WAIS) score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Change in functional connectivity
时间窗: Day 3, Day 9, Day 17, and 1 month
Participants will undergo MRI at rest and fMRI scan while conducting the N-back task pre-intervention, mid-intervention, after 10 tDCS interventions, and post-intervention. The unitless average difference will be reported.
Change in Digit Span (WAIS IV) score
时间窗: Up to 4 months post-intervention
The Digit Span (WAIS IV) assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the Digit Span (WAIS) score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Number of transcranial direct current stimulation (tDCS) sessions completed
时间窗: Days 4-16
The number of tDCS sessions completed will be reported as a unitless average value as a measure of feasibility.
Change in D-KEFS Color Word score
时间窗: Up to 4 months post-intervention
The D-KEFS Color-Word Interference assessment will be used as a measure of cognitive performance pre- and post-intervention. Additionally, as a measure of generalization and durability, the D-KEFS Color Word score will be assessed pre-intervention, mid-intervention, post-intervention, and at monthly follow-up visits. The assessment is scored on a scale of 1-19, where higher scores indicate higher cognitive functioning. The unitless average difference will be reported.
Change in task-evoked functional magnetic resonance signal
时间窗: Day 3, Day 9, Day 17, and 1 month
Participants will undergo MRI at rest and fMRI scan while conducting the N-back task pre-intervention, mid-intervention, after 10 tDCS interventions, and post-intervention. The unitless average difference will be reported.
次要结局
未报告次要终点