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

Primary Purpose

Obsessive-Compulsive Disorder, Pediatric Psychiatric Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obsessive-Compulsive Disorder focused on measuring Transcranial Direct Current Stimulation

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Inhibitory Control/ Fear Extinction

Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Stop Signal Task
Ability to Inhibit a Response Task
Change in Fear Extinction Recall Task
Degree of recall to a previously extinguished conditioned stimulus
Change in Sequential Spaceship Task
Ability to increase the proportion of Goal-Orientated versus Habit-Based Behaviour

Secondary Outcome Measures

Change in EEG readings
Degree and type of change in event related potentials (ERPs) amplitudes

Full Information

First Posted
June 26, 2020
Last Updated
April 10, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04548609
Brief Title
Transcranial Direct Current Stimulation (tDCS) in Pediatric Obsessive Compulsive Disorder (OCD)
Official Title
Transcranial Direct Current Stimulation (tDCS) Modulation of Neurocognitive Processes Underlying Pediatric Obsessive Compulsive Disorder (OCD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder, Pediatric Psychiatric Disorder
Keywords
Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inhibitory Control/ Fear Extinction
Arm Type
Experimental
Arm Description
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.
Arm Title
Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Primary Outcome Measure Information:
Title
Change in Stop Signal Task
Description
Ability to Inhibit a Response Task
Time Frame
50 minutes- 20 minutes before and immediately after a single 30 minute tDCS session
Title
Change in Fear Extinction Recall Task
Description
Degree of recall to a previously extinguished conditioned stimulus
Time Frame
Within 12-24 hours after the tDCS session the day before
Title
Change in Sequential Spaceship Task
Description
Ability to increase the proportion of Goal-Orientated versus Habit-Based Behaviour
Time Frame
40 minutes- immediately before and 10 minutes after a 30 minute single tDCS session
Secondary Outcome Measure Information:
Title
Change in EEG readings
Description
Degree and type of change in event related potentials (ERPs) amplitudes
Time Frame
90 minutes- 30 minutes before and 30 minutes after a single 30 minute tDCS session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 18.5. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joan Camprodon, MD, PhD, MPH
Phone
6177265348
Email
JCAMPRODON@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Camprodon, MD, PhD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Geller, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Camprodon, MD, PhD, MPH
Phone
617-726-5348
Email
JCAMPRODON@mgh.harvard.edu

12. IPD Sharing Statement

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

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