Transcranial Direct Current Stimulation and Autism

February 22, 2023 updated by: Johns Hopkins University

The Use of Transcranial Direct Current Stimulation (tDCS) to Improve Communicative Efforts, Speech, Language and Related Cognitive Functions in Individuals With Autism

This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities, such as speech, language and other efforts at communication in individuals with autism.

In this research, battery powered device is used to deliver very weak electrical current to the surface of the scalp while participants are involved in tasks aimed at training or measuring communicative efforts, speech, language or related cognitive functions. Our aim is to find out whether tDCS will improve these mental abilities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants in the study will be asked to do the following things:

  • Grant permission for the researchers to view medical/psychological and/or educational and/or speech records associated with the diagnosis of low-functioning autism.
  • Complete a questionnaire and provide a health history.
  • Complete evaluations by our study team to assess the diagnosis and gain a clearer understanding of the participant's current functioning.
  • Give permission to audio and video-tape test sessions for later scoring and observation.
  • Give permission to audio or video-tape in the classroom or home environment using non-intrusive audio-visual recording devices.
  • Complete several tasks and training interventions that involve such things as learning new words or pictures, saying words out loud, or naming objects.
  • Participate in an eye tracking study while completing a task on the computer which involves wearing a headband, attached by a velcro fastener, which contains a magnetic sensor. This equipment allows us to track the position of the head in order to record more accurate measurements. It is used with eye tracking equipment which measures the gaze on a set point on a computer screen. The equipment poses no risk and is non-invasive.
  • Participate in computerized tasks while monitoring brain responses that are a direct result of a thought or perception. In order to monitor these responses, electrodes would be placed over various points on your scalp. The electrodes will record the on-going activity of the brain; it does not produce or introduce any electrical activity. The equipment poses no risk and is non-invasive.
  • Wear electrodes that will be placed on the scalp with a large rubberized band. These electrodes will administer very weak electrical current (tDCS) from a battery powered device for 20 to 60 minutes.

The experimental sessions will last about 1 hour and participants may be asked to have more than one testing session in a day or to return for additional sessions.

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Department of Neurology; Cognitive Neurology/Neuropsychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 79 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The experimental group will consist of adults with autism (n=40). Participants will be 18-79 years of age, diagnosed with autism by independent clinicians and confirmed by formal assessment (e.g., CDI, ADOS, Bayley, Sensory Profile), and with receptive and expressive vocabulary levels of ≥ 3 years age-equivalent, as assessed by standardized measures. Additionally, the Autism Diagnostic Interview will be administered to caregivers in order to appropriately identify specific areas (regarding speech, language and cognition) in which participants are experiencing the most difficulty.

Description

Inclusion Criteria:

  • Clinical diagnosis of autism or related conditions
  • Identified language deficit(s) and/or other cognitive or behavioral impairments (which will be specific to each sub-study)
  • Adequate ability to perform the research tasks set for the individual's particular level of performance

Exclusion Criteria:

  • Peripheral blindness or deafness
  • Any implanted metal device (precludes use of tDCS)
  • Any implanted cardiac pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Autism
Individuals with autism will have either Anodal, Cathodal, or Sham Transcranial Direct Current Stimulation (tDCS).
Procedure: Transcranial Direct Current Stimulation (tDCS)
Delivery of transcranial direct current stimulation for 30-60 minutes or sham stimulation.This will be administered by two or more similar devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Picture naming accuracy
Time Frame: 10 minutes
Oral naming of visually-presented pictures, measured in terms of accuracy. (Note: this task may not be included in the final design, nor given to all subjects)
10 minutes
Picture naming speed
Time Frame: 10 minutes
Oral naming of visually-presented pictures, measured in terms of speed (milliseconds). (Note: this task may not be included in the final design, nor given to all subjects)
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Barry Gordon, M.D., Ph.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 26, 2016

Study Completion (Actual)

February 21, 2023

Study Registration Dates

First Submitted

May 17, 2012

First Submitted That Met QC Criteria

May 21, 2012

First Posted (Estimate)

May 22, 2012

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00042345

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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