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Transcranial Direct Current Stimulation and Autism

This study is currently recruiting participants.
Verified March 2017 by Barry Gordon, M.D., Ph.D., Johns Hopkins University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01603225
First Posted: May 22, 2012
Last Update Posted: March 22, 2017
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.
Information provided by (Responsible Party):
Barry Gordon, M.D., Ph.D., Johns Hopkins University
  Purpose

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 Intervention
Autism Spectrum Disorders Procedure: Transcranial Direct Current Stimulation (tDCS)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Transcranial Direct Current Stimulation (tDCS) to Improve Communicative Efforts, Speech, Language and Related Cognitive Functions in Individuals With Autism

Resource links provided by NLM:


Further study details as provided by Barry Gordon, M.D., Ph.D., Johns Hopkins University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: October 2015
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 79 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Alli Dallavecchia 443-287-1701 CogNeuroResearch@jhmi.edu

Locations
United States, Maryland
Department of Neurology; Cognitive Neurology/Neuropsychology Recruiting
Baltimore, Maryland, United States, 21231
Principal Investigator: Barry Gordon, M.D., Ph.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Barry Gordon, M.D., Ph.D. Johns Hopkins University
  More Information

Responsible Party: Barry Gordon, M.D., Ph.D., Editor-in-Chief, Cognitive and Behavioral Neurology Therapeutic Cognitive Neuroscience Professor Professor of Neurology and Cognitive Science Cognitive Neurology/Neuropsychology Dept. of Neurology The Johns Hopkins Medical Institutions, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01603225     History of Changes
Other Study ID Numbers: 42345
First Submitted: May 17, 2012
First Posted: May 22, 2012
Last Update Posted: March 22, 2017
Last Verified: March 2017

Keywords provided by Barry Gordon, M.D., Ph.D., Johns Hopkins University:
Autism
tDCS

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders