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Noninvasive Brain Stimulation
tDCS for OCD in Children
N/A
Recruiting
Led By Joan Camprodon, MD, PhD, MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Must not have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up90 minutes- 30 minutes before and 30 minutes after a single 30 minute tdcs session
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will test whether tDCS can help lessen OCD symptoms in children.
Eligible Conditions
- Pediatric Mental Health Disorder
- Obsessive-Compulsive Disorder
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 minutes- 30 minutes before and 30 minutes after a single 30 minute tdcs session
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 minutes- 30 minutes before and 30 minutes after a single 30 minute tdcs session
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Fear Extinction Recall Task
Change in Sequential Spaceship Task
Change in Stop Signal Task
Secondary outcome measures
Change in EEG readings
Side effects data
From 2021 Phase 2 & 3 trial • 160 Patients • NCT024834682%
skin irritation
2%
Car accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
tDCS (Active)
tDCS (Sham)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Inhibitory Control/ Goal-Orientated vs Habit-Based BehaviorExperimental Treatment1 Intervention
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.
Group II: Inhibitory Control/ Fear ExtinctionExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation
2014
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,862 Previous Clinical Trials
13,150,021 Total Patients Enrolled
Joan Camprodon, MD, PhD, MPHPrincipal InvestigatorMassachusetts General Hospital
5 Previous Clinical Trials
948 Total Patients Enrolled
Daniel Geller, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot participate if you have a history of epilepsy or have metal implants, brain or vagus nerve stimulators, VP shunt or pacemakers in your head or neck.Your body mass index (BMI) is too low.You have been diagnosed with certain mental health conditions like conduct disorder, autism, bipolar disorder, ADHD, Tourette's syndrome, schizophrenia, or schizoaffective disorders based on DSM-V criteria.Young people who have symptoms of hoarding because their condition may be different from other types of OCD.You are addicted to drugs or alcohol (excluding tobacco).You started taking an antidepressant within 12 weeks or an antipsychotic within 6 weeks before joining the study. You cannot start any new alternative medications, special diets, or therapies within 6 weeks of joining the study.If you are currently receiving therapy for your OCD, you cannot participate in the study unless it is for maintenance purposes only. However, if you have been receiving therapy for other psychological issues for at least 8 weeks, you may still be eligible to enroll.You have had suicidal thoughts or behaviors within the past 6 months and need to receive proper mental health treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Inhibitory Control/ Fear Extinction
- Group 2: Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What characteristics make a patient eligible for this clinical investigation?
"For this medical investigation, 36 outpatients aged 10 to 17 with a WASI-II IQ of at least 85 and who are suffering from obsessive compulsive disorder will be accepted. In cases where intellectual disability is suspected, the PI may administer an additional WASI-II test in order to reduce participant strain."
Answered by AI
Is recruitment for this research endeavor still open?
"Affirmative. The information hosted on clinicaltrials.gov reveals that this study is recruiting. It was initially posted on January 25th 2021 and the most recent update occurred on July 21st 2022. This trial requires 36 participants from a single medical center to be enrolled in order for it to move ahead with research plans."
Answered by AI
Are individuals aged 55 and above eligible for enrollment in this trial?
"This research project is open to participants whose age ranges from 10 years old and under 17."
Answered by AI
How many participants are currently enlisted in this clinical trial?
"Affirmative, clinicaltrials.gov confirms that recruitment for this experiment is in progress. This trial was published on January 25th 2021 and most recently updated July 21st 2022 with the goal of recruiting 36 participants from one medical centre."
Answered by AI
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