Transcranial Direct Current Stimulation (tDCS) Modulation of Neurocognitive Processes Underlying Pediatric Obsessive Compulsive Disorder (OCD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Change in Sequential Spaceship Task
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •Presence of a significant and/or unstable medical illness that might lead to hospitalization during the study.
Arms & Interventions
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.
Intervention: Transcranial Direct Current Stimulation (Device)
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.
Intervention: Transcranial Direct Current Stimulation (Device)
Outcomes
Primary Outcomes
Change in Sequential Spaceship Task
Time Frame: 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
Change in Model-Based Index on the Two-stage Sequential Reinforcement Learning Task (Sequential Spaceship Task)
Time Frame: 40 minutes- immediately before and 10 minutes after a 30 minute single tDCS session
Decision-making task that quantifies the relative contribution of model-based (goal-directed) vs model-free (habit-based) choice strategies. The Model-Based Index, is derived from each participant's probability of repeating their first-stage choice on the following trial, computed separately for four combinations of prior-trial outcome (rewarded or unrewarded) and transition type (common or rare): (stay probability after rewarded-common trials minus stay probability after rewarded-rare trials) plus (stay probability after unrewarded-rare trials minus stay probability after unrewarded-common trials). The index ranges from -2.0 to 2.0. A score near 0 indicates choices driven primarily by recent reward history regardless of transition type (model-free/habit-based responding), while higher positive scores indicate choices that are additionally sensitive to the task's transition structure (model-based/goal-directed responding). Higher scores means greater degree of goal-directed control.
Change in Stop Signal Task
Time Frame: 50 minutes- 20 minutes before and immediately after a single 30 minute tDCS session
Ability to Inhibit a Response Task For the stop-signal task, the outcome of inhibitory control is measured by the stop signal reaction time (SSRT), calculated by subtracting the stop signal delay (SSD) from the go signal response time (RT).
Change in Fear Extinction Recall Task
Time Frame: Within 12-24 hours after the tDCS session the day before
Degree of recall to a previously extinguished conditioned stimulus.
Secondary Outcomes
- Change in EEG readings(90 minutes- 30 minutes before and 30 minutes after a single 30 minute tDCS session)
- Change in EEG Readings(90 minutes- 30 minutes before and 30 minutes after a single 30 minute tDCS session)
Investigators
Daniel A. Geller
Founder and Director of Research, Pediatric OCD and Tic Disorders Program
Massachusetts General Hospital