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Noninvasive Brain Stimulation
Transcranial Direct Current Stimulation for Pediatric OCD
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
Outpatient youth between the ages 10-17 years
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 minutes- 30 minutes before and 30 minutes after a single 30 minute tdcs session
Awards & highlights
Study Summary
This trial will test whether tDCS can help lessen OCD symptoms in children.
Who is the study for?
This trial is for kids aged 10-17 with moderate to severe OCD, as measured by a specific scale. They must have an IQ of at least 85 and speak English. Kids can't join if they've had recent medication changes, certain mental health diagnoses, are underweight, pregnant or nursing, or have metal implants in the head/neck.Check my eligibility
What is being tested?
The study tests how transcranial direct current stimulation (tDCS) affects brain processes related to OCD in children. It's non-invasive and aims to modulate neural activity that contributes to the disorder.See study design
What are the potential side effects?
While tDCS is generally considered safe, potential side effects may include mild itching, tingling or discomfort at the electrode sites during stimulation. There could also be fatigue or headache after treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 10 and 17 years old.
Timeline
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%
Car accident
2%
skin irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
tDCS (Active)
tDCS (Sham)
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
2,931 Previous Clinical Trials
13,198,409 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:- I am between 10 and 17 years old.I am a young person with symptoms of hoarding.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.I have not had suicidal thoughts or behaviors in the last 6 months.I don't have epilepsy, metal implants in my head/neck, brain devices, or a pacemaker.My mental health medication has been stable for at least 6 weeks.Your body mass index (BMI) is too low.I do not have a severe illness that could hospitalize me during the study.You are addicted to drugs or alcohol (excluding tobacco).I am currently not in psychotherapy for OCD, but may be receiving it for other mental health issues.I haven't started new antidepressants, antipsychotics, or diets in the weeks before joining the study.
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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