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Non-invasive Brain Stimulation
Non-invasive Brain Stimulation for Autism
N/A
Recruiting
Led By Barbie Zimmerman-Bier, M.D.
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once during baseline (if a similar test was not done in the past three years)
Awards & highlights
Summary
This trial will use tDCS in combination with ABA to see if it can improve the acquisition of educational programs for children with ASD.
Who is the study for?
This trial is for children aged 5-12 with autism, enrolled in an ABA program. They must have stable medical and behavioral treatments for at least a month before the study and be able to wear tDCS equipment after desensitization training. Children with metal implants, recent seizures, certain medication use (like serotonin reuptake inhibitors or dopamine affecting drugs), severe neurological issues, sensory impairments, or those on medications that might interfere with tDCS are excluded.
What is being tested?
The trial tests if transcranial direct current stimulation (tDCS) can help improve learning when combined with applied behavior analysis (ABA). It involves low-level electrical neurostimulation aimed at enhancing brain function related to learning. Participants will receive either actual tDCS or a sham (placebo) version without active stimulation.
What are the potential side effects?
tDCS is generally safe and well-tolerated by children with ASD. Potential side effects may include mild discomfort at the site of electrode placement, itching under the electrodes during stimulation, headache, fatigue, nausea or tingling sensations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ once during baseline (if a similar test was not done in the past three years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once during baseline (if a similar test was not done in the past three years)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Electrodncephalogram (EEG)
Change in the Behavior Rating Inventory of Executive Function (BRIEF)
Secondary study objectives
Change in discrete trial training (DTT) data from applied behavior analysis (ABA) therapy
Change in the Pervasive Developmental Disorder Behavior Inventory (PDDBI)
Other study objectives
Leiter-3 nonverbal intelligence assessment (for demographic purposes)
Vineland Adaptive Behavior Scales (for demographic purposes)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCS firstExperimental Treatment2 Interventions
\[Active stimulation first, then crossover to Sham stimulation\]
Each participant will receive BOTH sham or active tDCS but the order of each will be randomized. The active tDCS and sham are procedurally identical. Participants in both arms will have the initial tingling sensation and the active tDCS stimulation will CONTINUE for 20 minutes at 1 mA (milliamps). All tDCS sessions will occur during ABA therapy.
Group II: Sham tDCS firstPlacebo Group2 Interventions
\[Sham stimulation first, then crossover to Active stimulation\]
Each participant will receive BOTH sham or active tDCS but the order of each will be randomized. The active tDCS and sham are procedurally identical. Participants in both arms will have the initial tingling sensation, except in sham stimulation, the current will be DISCONTINUED after 30 seconds while the power indicator remains on for the remainder of 20 minutes at 0 mA (milliamps). All tDCS sessions will occur during ABA therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham tDCS
2016
Completed Phase 1
~900
Transcranial Direct Current Stimulation (tDCS)
2016
Completed Phase 2
~2130
Find a Location
Who is running the clinical trial?
New York State Institute for Basic ResearchOTHER_GOV
6 Previous Clinical Trials
940 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
241 Patients Enrolled for Autism Spectrum Disorder
Rutgers, The State University of New JerseyLead Sponsor
440 Previous Clinical Trials
65,358 Total Patients Enrolled
9 Trials studying Autism Spectrum Disorder
153 Patients Enrolled for Autism Spectrum Disorder
Boston Children's HospitalOTHER
778 Previous Clinical Trials
5,580,988 Total Patients Enrolled
21 Trials studying Autism Spectrum Disorder
5,366 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a hole or opening in your skull.You are taking medications that affect dopamine, such as drugs for Parkinson's disease or antipsychotic medications.You have had a seizure within the past two years.You are taking medications that block sodium or calcium channels, which includes certain anti-seizure medications., are required
It is necessary to have stable medical and behavioural treatments for at least 4 weeks prior to and during the study.Boys and girls between the ages of 5 and 12 who have autism.You have complete loss of vision or hearing in your peripheral (side) vision or hearing.If you are taking certain medications, you will not be able to participate in the study because they could interfere with the results.You are taking medications or substances that can increase the risk of seizures.You have a history of receiving magnetic or electrical stimulation treatments.The individual was able to wear the tDCS device for a week without any adverse effects.You are taking medications that affect norepinephrine, like propranolol or stimulant drugs.You have a serious brain condition like a traumatic brain injury, brain tumor, or infection inside your brain.You are taking medications that affect the NMDA receptors, like dextromethorphan or cycloserine.You have a current skin condition that is severe or causing discomfort.
Research Study Groups:
This trial has the following groups:- Group 1: Sham tDCS first
- Group 2: Active tDCS first
Awards:
This trial has 0 awards, including: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.
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