Transcranial Direct Current Stimulation and Low-Functioning Autism

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2012 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Barry Gordon, M.D., Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01603225
First received: May 17, 2012
Last updated: May 21, 2012
Last verified: May 2012
  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 low-functioning autism.

In this research, a 9 volt battery 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 Low-Functioning Autism

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Groups/Cohorts Assigned Interventions
Low-functioning autism
Individuals with low-functioning autism
Procedure: Transcranial Direct Current Stimulation (tDCS)
Only active tDCS will be administered: either anodal or cathodal 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 9 volt battery 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

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The experimental group will consist of adults with low-functioning autism (n=20). Participants will be 18-49 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
  • Little or no functional oral speech production
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603225

Contacts
Contact: Patrick Chambers, M.Ed. 410-502-2640 pchambe3@jhmi.edu
Contact: Julia Hernandez 410-955-7789

Locations
United States, Maryland
Department of Neurology; Cognitive Neurology/Neuropsychology Not yet 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

No publications provided

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
Study First Received: May 17, 2012
Last Updated: May 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Low-functioning autism
tDCS

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014