Transcranial Direct Current Stimulation and Autism

Autism Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603225
• Other study ID #: NA_00042345
• Status: Completed
• Start date: October 2015
• Est. completion date: February 21, 2023

Study information

• Verified date: February 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 21, 2023
• Est. primary completion date: December 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Department of Neurology; Cognitive Neurology/Neuropsychology	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Picture naming accuracy	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
Primary	Picture naming speed	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