Transcranial Direct Current Stimulation (tDCS) in Pediatric Obsessive Compulsive Disorder (OCD)

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Transcranial Direct Current Stimulation (tDCS) Modulation of Neurocognitive Processes Underlying Pediatric Obsessive Compulsive Disorder (OCD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04548609
• Other study ID #: 2020P000847
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: Joan Camprodon, MD, PhD, MPH
• Phone: 6177265348
• Email: JCAMPRODON[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Outpatient youth between the ages 10-17 years

2. 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.

3. 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.

4. English speaking.

Exclusion Criteria:

1. 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.

2. 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.

3. 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.

4. Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical care.

5. 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

6. Youth with hoarding symptoms as they may be conceptually and genetically different from other OCD subtypes.

7. BMI less than 18.5.

8. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, ventriculoperitoneal (VP) shunt, pacemakers.

9. Active substance dependence (except for tobacco).

10. Pregnant or nursing females as the effects of tDCS on pregnancy are unknown.

11. Presence of a significant and/or unstable medical illness that might lead to hospitalization during the study.

Related Conditions & MeSH terms

• Mental Disorders
• Obsessive-Compulsive Disorder
• Pediatric Psychiatric Disorder
• Problem Behavior

Intervention

Device:
• Transcranial Direct Current Stimulation
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Stop Signal Task	Ability to Inhibit a Response Task	50 minutes- 20 minutes before and immediately after a single 30 minute tDCS session
Primary	Change in Fear Extinction Recall Task	Degree of recall to a previously extinguished conditioned stimulus	Within 12-24 hours after the tDCS session the day before
Primary	Change in Sequential Spaceship Task	Ability to increase the proportion of Goal-Orientated versus Habit-Based Behaviour	40 minutes- immediately before and 10 minutes after a 30 minute single tDCS session
Secondary	Change in EEG readings	Degree and type of change in event related potentials (ERPs) amplitudes	90 minutes- 30 minutes before and 30 minutes after a single 30 minute tDCS session