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Non-invasive Brain Stimulation in Children With Autism

Primary Purpose

Autism Spectrum Disorder, Executive Dysfunction, Child Autism

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial Direct Current Stimulation (tDCS)

Sham tDCS

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Transcranial Direct Current Stimulation, Noninvasive Brain Stimulation, Applied Behavior Analysis, Executive Function, Electroencephalogram (EEG)

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males and females between 5 and 12 years with autism
Enrolled in an ABA program (school or in-home) supervised by a Board Certified Behavior Analyst (BCBA)
Stable medical and behavioral treatments for at least 4 weeks prior to, and during the study
Able to tolerate wearing tDCS as determined during a week-long daily desensitization training.

Exclusion Criteria:

Any implanted metal device (heart pacemaker, cochlear implant, surgical clips, etc.)
Severe neurological disorders such as TBI, brain tumor, intracranial infection
Seizure disorder with a seizure within the last two years
Skull defect
Peripheral blindness or deafness
Medication that might affect tDCS: There have been a few studies concerning the effect of various medications on tDCS. Some may block and others may enhance the effects depending on many factors. The assay used to test these medications was its effect on the motor cortex after stimulation and this may not apply to our montages, however, in order to minimize the chances of having medication affect our results, participants taking the following medications will be excluded:
1. Na or Ca channel blockers which will include all anti-seizure medications
2. Medications that affect the NMDA receptors including dextromethorphan, cycloserine
3. Serotonin reuptake inhibitors
4. Dopamine stimulating or blocking medications including pergolide, bromocriptine and all antipsychotic medications
5. Norepinephrine stimulating or blocking agents including propranolol and the stimulants
6. Drugs that can lower seizure threshold [imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, phencyclidine, ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline]
7. Barbiturates, benzodiazepines, meprobamate, chloral hydrate in the past 4 weeks
Acute skin disease
History of magnetic or electrical stimulation

Sites / Locations

Department of Pediatrics, Division of Pediatric Neurology, Robert Wood Johnson Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS first

Sham tDCS first

Arm Description

[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.

[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.

Outcomes

Primary Outcome Measures

Change in the Behavior Rating Inventory of Executive Function (BRIEF)

The BRIEF is a parent-reported executive function questionnaire which utilizes T-scores, which has a mean of 50 with a standard deviation of 10, with a range of 10-100

Change in Electrodncephalogram (EEG)

Power, sample entropy, Lyapunov exponent, detrended fluctuation analysis, correlation dimension, and recurrence quantitative analysis (RQA) values on all frequency bands (delta, theta, alpha, beta, gamma, and gamma+) will be computed from 2-minute resting EEGs using a portable headset

Secondary Outcome Measures

Change in the Pervasive Developmental Disorder Behavior Inventory (PDDBI)

The PDDBI is a parent-reported questionnaire about the symptoms of ASD. The PDDBI utilizes T-scores, which has a mean of 50 with a standard deviation of 10, with a range of 10-100. The higher the Approach/Withdrawal Problems and the higher the Autism scores, the more severe the deficits. The higher the Receptive/Expressive Social Communication scores, the better the competence in these areas

Change in discrete trial training (DTT) data from applied behavior analysis (ABA) therapy

Individualized behavior data from ABA therapy

Full Information

NCT ID

NCT05105126

First Posted

September 20, 2021

Last Updated

February 13, 2023

Sponsor

Rutgers, The State University of New Jersey

Collaborators

New York State Institute for Basic Research, Boston Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05105126

Brief Title

Non-invasive Brain Stimulation in Children With Autism

Official Title

A Pilot Study of Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2022 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

Collaborators

New York State Institute for Basic Research, Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Although many children diagnosed with autism spectrum disorder (ASD) make significant progress in learning and their cognitive skills improve with applied behavior analysis (ABA), there are a significant number of children who show an absence or a plateau in various skills. Deficits in executive functioning are likely to be involved in many of these cognitive and learning disabilities due to poor functioning of the prefrontal cortex. Currently, the use of biological methods for improving learning and cognition is largely unexplored in research and practice. The aim of this study is to use of transcranial direct current stimulation (tDCS) in combination with ABA to improve the acquisition of educational programs for students with ASD. tDCS is a low-level electrical neurostimulation and is most effective when used in combination with an active training or teaching, facilitating the neuronal circuits used for that task. tDCS has been used for various indications over a couple of decades and has been shown to be very safe and has been well-tolerated by children with ASD. The mechanism of tDCS is not clear, however animal studies show that tDCS can stimulate the flow of calcium ions through channels in the astrocytes, activating them, and facilitating their role in synapse formation and therefore learning.

Detailed Description

Children with ASD experience a wide range of outcomes, and not all children respond effectively to behavioral interventions. This study uses a novel biologic intervention that combines electrical brain stimulation with ABA treatment to target some of the cognitive deficits in ASD that until now have been relatively refractory to treatment. There is accumulating evidence of tDCS being effective in treating the comorbidities as well as the core symptoms of ASD. tDCS is most effective when used simultaneously with an active intervention. In this study, the effects of tDCS alone and in combination with ABA on the executive functioning skills and the core symptoms of ASD will be examined and monitored using an objective neurophysiological test (EEG). This is a double-blind, sham-controlled crossover study involving 20 participants. tDCS will be administered while ABA therapy is being implemented. Programs aimed at language and other cognitive functions will be emphasized. tDCS will be applied bi-frontally with the anode at F3 and the cathode at F4. Forty stimulation sessions will be done (20 active, 20 sham) lasting 20 minutes per session, at 1 milliampere.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder, Executive Dysfunction, Child Autism

Keywords

Autism Spectrum Disorder, Transcranial Direct Current Stimulation, Noninvasive Brain Stimulation, Applied Behavior Analysis, Executive Function, Electroencephalogram (EEG)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

The study will use a randomized double-blind controlled placebo (sham vs. active tDCS) crossover design. The study will involve 5 total months of participation. Participants will be randomized into one of the two groups: Group A) 20 active tDCS stimulation followed by 20 sham stimulation; or Group B) 20 sham stimulation followed by 20 active tDCS stimulation

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Study investigators will utilize the generated randomization schedule to provide active tDCS and sham stimulation codes that will be entered into the tDCS device (by the caregiver) prior to each session. These numeric codes will be random numbers and not distinct to the study group assignment, protecting the blind. One of the study investigators who will program the tDCS device will remain unblinded and will not be involved in any treatment outcome assessments. All other study staff, including the PI and the co-PIs remain blind. Parents, participants, and ABA providers will also remain blind.

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active tDCS first

Arm Type

Experimental

Arm Description

Arm Title

Sham tDCS first

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation (tDCS)

Intervention Description

The anodal electrode will be placed over F3 using the international 10-20 EEG electrode placement system to target the left dorsolateral prefrontal cortex (DLPFC). The cathode electrode will be placed on the right dorsolateral prefrontal cortex. 40 stimulation sessions will be completed (20 active, 20 sham), each lasting 20 minutes per session at 1.0mA.

Intervention Type

Device

Intervention Name(s)

Sham tDCS

Intervention Description

Sham tDCS

Primary Outcome Measure Information:

Title

Change in the Behavior Rating Inventory of Executive Function (BRIEF)

Description

The BRIEF is a parent-reported executive function questionnaire which utilizes T-scores, which has a mean of 50 with a standard deviation of 10, with a range of 10-100

Time Frame

Change measured once per month for 5 months

Title

Change in Electrodncephalogram (EEG)

Description

Time Frame

Change measured once per month for 5 months

Secondary Outcome Measure Information:

Title

Change in the Pervasive Developmental Disorder Behavior Inventory (PDDBI)

Description

Time Frame

Change measured once per month for 5 months

Title

Change in discrete trial training (DTT) data from applied behavior analysis (ABA) therapy

Description

Individualized behavior data from ABA therapy

Time Frame

Obtained once at the completion of the study (5 months after the start of the study)

Other Pre-specified Outcome Measures:

Title

Vineland Adaptive Behavior Scales (for demographic purposes)

Description

Parent reported daily living skills

Time Frame

Once during baseline

Title

Leiter-3 nonverbal intelligence assessment (for demographic purposes)

Description

Nonverbal intelligence test

Time Frame

Once during baseline (if a similar test was not done in the past three years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and females between 5 and 12 years with autism Enrolled in an ABA program (school or in-home) supervised by a Board Certified Behavior Analyst (BCBA) Stable medical and behavioral treatments for at least 4 weeks prior to, and during the study Able to tolerate wearing tDCS as determined during a week-long daily desensitization training. Exclusion Criteria: Any implanted metal device (heart pacemaker, cochlear implant, surgical clips, etc.) Severe neurological disorders such as TBI, brain tumor, intracranial infection Seizure disorder with a seizure within the last two years Skull defect Peripheral blindness or deafness Medication that might affect tDCS: There have been a few studies concerning the effect of various medications on tDCS. Some may block and others may enhance the effects depending on many factors. The assay used to test these medications was its effect on the motor cortex after stimulation and this may not apply to our montages, however, in order to minimize the chances of having medication affect our results, participants taking the following medications will be excluded: Na or Ca channel blockers which will include all anti-seizure medications Medications that affect the NMDA receptors including dextromethorphan, cycloserine Serotonin reuptake inhibitors Dopamine stimulating or blocking medications including pergolide, bromocriptine and all antipsychotic medications Norepinephrine stimulating or blocking agents including propranolol and the stimulants Drugs that can lower seizure threshold [imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, phencyclidine, ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline] Barbiturates, benzodiazepines, meprobamate, chloral hydrate in the past 4 weeks Acute skin disease History of magnetic or electrical stimulation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

J. Helen Yoo, Ph.D.

Phone

(718) 494-5295

JHelen.Yoo@opwdd.ny.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Eric B London, M.D.

Phone

(718) 494-3695

naarlondon@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbie Zimmerman-Bier, M.D.

Organizational Affiliation

Department of Pediatrics, Division of Pediatric Neurology Robert Wood Johnson Medical School (RWJMS)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Pediatrics, Division of Pediatric Neurology, Robert Wood Johnson Medical School

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Barbie Zimmerman-Bier, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Non-invasive Brain Stimulation in Children With Autism

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