tDCS and Cognitive Training for Restrictive Eating Disorders
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- the rate of dropout.
研究概览
简要总结
This study looks at adults with restrictive eating disorders who are currently receiving outpatient treatment for their eating disorder to examine whether a new brain stimulation technique called non-invasive transcranial direct current stimulation (tDCS) can enhance brain training. Participation involves interviews, assessments, 10 sessions of brain stimulation (active or sham), and computerized brain training over a 3-4 week period, with one post-intervention visit, and one 1-month follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
triple blind
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
- •Age 18-65 years
- •Self-reported enrollment in outpatient-level treatment at local eating disorder treatment centers in the Twin Cities region, and meeting DSM-5 criteria for AN (mild severity, based on BMI greater than or equal to 17.0 kg/m2) or atypical AN diagnosis (based on MINI and EDE assessments).
- •Participant must be capable of giving informed consent, based on UCSD Brief Assessment of Capacity to Consent (UBACC) risk assessment.
- •Sufficient spoken English so as to be able to comprehend testing procedures. Normative ranges on a C-RENAL blood panel (panel and ranges specified here: https://labguide.fairview.org/showtest.asp?testid=3321)
排除标准
- •Substance abuse in the participant
- •Neurological condition or other developmental disorder
- •Serious psychiatric disorder known to affect brain functioning and cognitive performance (e.g., schizophrenia, schizoaffective disorder)
- •Medical instability, which will be evident based on required outpatient treatment status. In standard eating disorders treatment, individuals who are not medically stable are referred to higher levels of care (e.g., residential treatment, inpatient). Therefore, if a participant is enrolled in higher level care for their eating disorder diagnosis, this indicates medical instability and they will be excluded from enrollment in this study.
- •tDCS contraindication (e.g., history of craniotomy, history of metallic cranial plates, screws, implanted devices).
- •Acute suicidality (suicidalideation with a plan or intent), assessed via MINI suicidality module and Beck Depression Inventory suicide item
- •Acute homicidality (homicidal ideation with a plan or intent), assessed via MINI
- •Moderate, severe or extreme AN diagnostic severity, based on BMI as per DSM-5 criteria (e.g., BMI <17.0 kg/m2)
研究组 & 干预措施
Active tDCS
10 Active tDCS sessions: 10 active sessions of transcranial direct current stimulation paired with cognitive training tasks. Device used is StarStim.
干预措施: Active tDCS sessions, StarStim device (Device)
Sham (fake) tDCS
10 Sham (fake) tDCS sessions: 10 fake sessions of transcranial direct current stimulation paired with cognitive training tasks. The device will be on the participants head, but the current will not be active.
干预措施: Sham (fake) tDCS sessions (Device)
结局指标
主要结局
the rate of dropout.
时间窗: 14 days average
Feasibility and tolerability measure 1. Evaluating for less than 20% dropout over the course of the tDCS for R-EDs study.
Number of participants retained in the tDCS
时间窗: 14 days average
Feasibility and tolerability measure 2 . # of participants retained in the tDCS and cognitive training space of the study (80% or more retention will be used as the assessment threshold).
probabilistic reversal learning task
时间窗: 14 days average
Change from pre intervention to post intervention scores in probabilistic reversal learning task performance
Dimensional set shifting task
时间窗: 14 days average
change from pre to post intervention scores in dimensional set shifting task.
次要结局
未报告次要终点