Transcranial Direct Current Stimulation and Autism
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01603225|
Recruitment Status : Recruiting
First Posted : May 22, 2012
Last Update Posted : April 5, 2018
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.
|Condition or disease||Intervention/treatment|
|Autism Spectrum Disorders||Procedure: Transcranial Direct Current Stimulation (tDCS)|
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|
|Estimated Enrollment :||40 participants|
|Official Title:||The Use of Transcranial Direct Current Stimulation (tDCS) to Improve Communicative Efforts, Speech, Language and Related Cognitive Functions in Individuals With Autism|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||December 2025|
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.
- Expressive and receptive language output [ Time Frame: The average time frame is 1 hour ]Expressive and receptive language output as measured by video-monitoring, Noldus, EMs, and ERPs. However, these variables will change across participants and may include measurement of any of the following: general mental abilities required for communication and language (i.e., intention to communicate, symbolic association, semantics, and working memory), oral sound production, visual perception (e.g., picture selection), auditory perception, attention,executive functioning, motivation and/or other behavioral aspects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603225
|Contact: Alli Dallavecchia||443-287-1701||CogNeuroResearch@jhmi.edu|
|United States, Maryland|
|Department of Neurology; Cognitive Neurology/Neuropsychology||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator: Barry Gordon, M.D., Ph.D.|
|Principal Investigator:||Barry Gordon, M.D., Ph.D.||Johns Hopkins University|