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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)

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and once during baseline (if a similar test was not done in the past three years) for reporting.

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

~2150