Transcranial Direct Current Stimulation (tDCS) Modulation of Neurocognitive Processes Underlying Pediatric Obsessive Compulsive Disorder (OCD)
概览
- 阶段
- 不适用
- 干预措施
- Transcranial Direct Current Stimulation
- 疾病 / 适应症
- Obsessive-Compulsive Disorder
- 发起方
- Massachusetts General Hospital
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Stop Signal Task
- 状态
- 终止
- 最后更新
- 上个月
概览
简要总结
In this study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in modulating aberrant neurocognitive processes implicated in pediatric patients with obsessive compulsive disorder (OCD).
详细描述
In this study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in modulating aberrant neurocognitive processes implicated in pediatric patients with obsessive compulsive disorder (OCD). The investigators propose two arms of the study that will investigate fear extinction learning and inhibitory control in one arm (A), and goal orientated versus habit-based behavior and inhibitory control in the other (B). All subjects will undergo three study conditions: two with active tDCS to each of two different brain targets and one under sham tDCS. The order of stimulation (sham or active tDCS) will be randomized.
研究者
Joan A Camprodon, MD MPH PhD
Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation
Massachusetts General Hospital
入排标准
入选标准
- •Outpatient youth between the ages 10-17 years
- •Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) ≥16 (moderately severe). OCD must be determined to be the primary or co-primary diagnosis using the The Schedule for Affective Disorders and Schizophrenia for School-Age Children- Computer administered version (KSADS-COMP) based on all available information.
- •Child has a full-scale IQ≥85 as assessed on the Wechsler Abbreviated Scale of Intelligence® Second Edition (WASI®-II) (within 90% CI). To decrease participant burden, the WASI®-II will only be conducted in cases of suspected intellectual disability after meeting with the PI.
- •English speaking.
排除标准
- •Receiving concurrent psychotherapy for subject's OCD (except maintenance).Subjects receiving pre- established concurrent psychotherapy for at least 8 weeks regarding other psychological issues are eligible for enrollment.
- •New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritional or therapeutic diets within 6 weeks of study enrolment.
- •Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics, stimulant, alpha agonist) within 8 weeks before study enrollment (6 weeks for antipsychotic). Alternative medications must be stable for 6 weeks prior to baseline. Any medications must remain stable during treatment; consistent with the National Institute of Health (NIH)-funded Child Anxiety Multimodal Study (CAMS) trial, downward adjustments due to side effects may be acceptable and will be discussed with the study child and adolescent psychiatrist and the community psychiatrist.
- •Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical care.
- •Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for conduct disorder, autism, bipolar, attention deficit hyperactivity disorder (ADHD), Tourette's syndrome, schizophrenia or schizoaffective disorders
- •Youth with hoarding symptoms as they may be conceptually and genetically different from other OCD subtypes.
- •BMI less than 18.
- •Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, ventriculoperitoneal (VP) shunt, pacemakers.
- •Active substance dependence (except for tobacco).
- •Pregnant or nursing females as the effects of tDCS on pregnancy are unknown.
研究组 & 干预措施
Inhibitory Control/ Fear Extinction
This arm will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
干预措施: Transcranial Direct Current Stimulation
Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior
This arm will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
干预措施: Transcranial Direct Current Stimulation
结局指标
主要结局
Change in Stop Signal Task
时间窗: 50 minutes- 20 minutes before and immediately after a single 30 minute tDCS session
Ability to Inhibit a Response Task
Change in Fear Extinction Recall Task
时间窗: Within 12-24 hours after the tDCS session the day before
Degree of recall to a previously extinguished conditioned stimulus
Change in Sequential Spaceship Task
时间窗: 40 minutes- immediately before and 10 minutes after a 30 minute single tDCS session
Ability to increase the proportion of Goal-Orientated versus Habit-Based Behaviour
次要结局
- Change in EEG readings(90 minutes- 30 minutes before and 30 minutes after a single 30 minute tDCS session)