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Completed

NCT Number: NCT01603225

Transcranial Direct Current Stimulation and 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.

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Key information

Age range

14 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology; Cognitive Neurology/Neuropsychology

Baltimore, Maryland, 21231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation (tDCS)

Procedure

Delivery of transcranial direct current stimulation for 30-60 minutes or sham stimulation.This will be administered by two or more similar devices.

Primary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2023
First posted
May 22, 2012
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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