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Device
tDCS for Acquired Brain Injury
N/A
Waitlist Available
Led By Stacy J Suskauer, MD
Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 5 through 17 years
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 months
Awards & highlights
Study Summary
This trial will explore whether transcranial direct current stimulation is a safe and tolerable intervention for children with acquired brain injury, as well as whether EEG can predict response to the intervention.
Who is the study for?
This trial is for children aged 5-17 with acquired brain injury, currently inpatient at the Kennedy Krieger Rehabilitation Unit. They must speak English. It's not for kids with certain hairstyles, those in foster care, severe brain lesions in specific areas, recent seizures, metal implants in head/neck area, need for daytime ventilation, very small head size or profound hearing loss.Check my eligibility
What is being tested?
The study tests the safety and workability of transcranial direct current stimulation (tDCS) on children with brain injuries. The tDCS dosage will be gradually increased to see how well it can be tolerated and if it's feasible as a treatment option.See study design
What are the potential side effects?
Potential side effects of tDCS may include discomfort at the electrode sites on the scalp, itching or tingling during stimulation, fatigue after treatment sessions, headache or nausea. These are generally mild and temporary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in adverse events (skin problems and/or seizures) as a measure of safety
Changes in pain and discomfort as a measure of safety and tolerability
Disruption of Care Form
+2 moreSecondary outcome measures
Changes in Neurobehavioral functioning
Trial Design
3Treatment groups
Experimental Treatment
Group I: Sham tDCSExperimental Treatment1 Intervention
Post initial screening and baseline data collection, all study participants (a single cohort of patients) will receive a single dose of sham tDCS for 20 minutes over the left dorsolateral prefrontal cortex (DLPFC) or the primary motor cortex in conjunction with Mozart piano sonata. For sham tDCS, the current will be ramped up and immediately ramped down for 30 seconds. The sham tDCS session will be preceded and followed by behavioral assessments.
Group II: 2-mA tDCSExperimental Treatment1 Intervention
Post 1-mA tDCS, we will again determine the eligibility of the participant to receive 2 mA current. After a minimum of 5 days post-1 mA stimulation (typically 7 days), the participant will receive a single dose of 2-mA current (if head circumference >52cm; children with head circumference 43-52cm will receive 1-mA) over left DLPFC or M1 in conjunction with Mozart piano sonata. The participant will receive 2-mA current for 20 minutes; the current will be ramped up for 30 seconds, will held constant at the determined intensity for 20 minutes, and then ramped down for 10 seconds. The 2-mA tDCS session will be preceded and followed by behavioral assessments.
Group III: 1-mA tDCSExperimental Treatment1 Intervention
Post sham-tDCS, we will determine the eligibility of the participant to receive 1 mA of real tDCS based on the occurrence of adverse events and seizures occurring within 5 days of the sham session. After a minimum of 5 days post-sham stimulation (and typically around 7 days later), the participant will receive a single dose of 1-mA current (for head circumference >52 cm; children with head circumference 43-52cm will receive 0.5-mA) over left DLPFC or M1 in conjunction with Mozart piano sonata. The participant will receive 1-mA current for 20 minutes; the current will be ramped up for 30 seconds, will held constant at the determined intensity for 20 minutes, and then ramped down for 10 seconds. The 1-mA tDCS session will be preceded and followed by behavioral assessments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tDCS
2017
Completed Phase 2
~640
Find a Location
Who is running the clinical trial?
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
88 Previous Clinical Trials
24,937 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,256 Previous Clinical Trials
14,820,070 Total Patients Enrolled
Stacy J Suskauer, MDPrincipal InvestigatorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a previous brain injury.Children who are in foster care.Children with a head circumference smaller than 43 cm.You have very serious hearing loss in both ears.You need a machine to help you breathe during the day.You have specific areas in your brain with extensive focal lesions in the left dorsolateral prefrontal cortex and bilateral primary motor cortex as shown in imaging tests or reports from your medical care.You have had seizures in the month before joining the study.You have experienced certain types of seizures or abnormal brain activity seen on a special brain wave test.Women who have tested positive for pregnancy.You have had surgery on your head, have metal implants in your head or neck, or have certain medical devices in your head or neck.
Research Study Groups:
This trial has the following groups:- Group 1: 1-mA tDCS
- Group 2: 2-mA tDCS
- Group 3: Sham tDCS
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.
Are researchers currently seeking out participants for this experiment?
"Affirmative. According to the records on clinicaltrials.gov, this experiment is accepting participants as of now. It was initially posted November 13th 2019 and has been updated most recently on March 14th 2022. The researchers require 10 individuals from a single site for participation in the trial.."
Answered by AI
Is this study open to individuals aged 20 and above?
"In accordance with the specified eligibility requirements, participants must be between 5 and 17 years of age."
Answered by AI
How many people are actively participating in this medical experiment?
"Correct. According to clinicaltrials.gov, this medical experiment is still recruiting participants since its initial posting date of November 13th 2019 and last update on March 14th 2022; the study calls for 10 individuals from one site."
Answered by AI
What are the qualifying criteria for participation in this research endeavor?
"This research study requires a maximum of 10 participants to have been diagnosed with some degree of consciousness disorder, and they must fall within the age bracket 5-17 years old."
Answered by AI
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