- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04548609
Transcranial Direct Current Stimulation (tDCS) in Pediatric Obsessive Compulsive Disorder (OCD)
April 10, 2023 updated by: Joan A Camprodon, MD MPH PhD, Massachusetts General Hospital
Transcranial Direct Current Stimulation (tDCS) Modulation of Neurocognitive Processes Underlying Pediatric Obsessive Compulsive Disorder (OCD)
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).
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joan Camprodon, MD, PhD, MPH
- Phone Number: 6177265348
- Email: JCAMPRODON@mgh.harvard.edu
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Joan Camprodon, MD, PhD, MPH
- Phone Number: 617-726-5348
- Email: JCAMPRODON@mgh.harvard.edu
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Other Names:
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Experimental: 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.
|
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Stop Signal Task
Time Frame: 50 minutes- 20 minutes before and immediately after a single 30 minute tDCS session
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Ability to Inhibit a Response Task
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50 minutes- 20 minutes before and immediately after a single 30 minute tDCS session
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Change in Fear Extinction Recall Task
Time Frame: Within 12-24 hours after the tDCS session the day before
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Degree of recall to a previously extinguished conditioned stimulus
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Within 12-24 hours after the tDCS session the day before
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Change in Sequential Spaceship Task
Time Frame: 40 minutes- immediately before and 10 minutes after a 30 minute single tDCS session
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Ability to increase the proportion of Goal-Orientated versus Habit-Based Behaviour
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40 minutes- immediately before and 10 minutes after a 30 minute single tDCS session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in EEG readings
Time Frame: 90 minutes- 30 minutes before and 30 minutes after a single 30 minute tDCS session
|
Degree and type of change in event related potentials (ERPs) amplitudes
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90 minutes- 30 minutes before and 30 minutes after a single 30 minute tDCS session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Geller, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 25, 2021
Primary Completion (Anticipated)
March 1, 2024
Study Completion (Anticipated)
March 1, 2024
Study Registration Dates
First Submitted
June 26, 2020
First Submitted That Met QC Criteria
September 11, 2020
First Posted (Actual)
September 14, 2020
Study Record Updates
Last Update Posted (Actual)
April 12, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020P000847
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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