Autism Spectrum DisordersNCT01603225
Transcranial Direct Current Stimulation and Autism
An observational study of Autism Spectrum Disorders, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 79 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 21 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Peripheral blindness or deafness
- Any implanted metal device (precludes use of tDCS)
- Any implanted cardiac pacemaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Neurology; Cognitive Neurology/Neuropsychology
Baltimore, Maryland, 21231
About this study
Official title: The Use of Transcranial Direct Current Stimulation (tDCS) to Improve Communicative Efforts, Speech, Language and Related Cognitive Functions in Individuals With 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.
Read the 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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- Autism, tDCS
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Procedure or surgery
Delivery of transcranial direct current stimulation for 30-60 minutes or sham stimulation.This will be administered by two or more similar devices.
| Study group | Role | What they receive |
|---|---|---|
| Autism | Individuals with autism will have either Anodal, Cathodal, or Sham Transcranial Direct Current Stimulation (tDCS). Receives: Procedure: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 10 minutes
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)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startOct 2015
- Primary completion26 Dec 2016
- Study completion21 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barry Gordon, M.D., Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603225
- Sponsor's protocol ID
- NA_00042345
- Status last verified
- Feb 2023
- First submitted
- 17 May 2012
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Transcranial Direct Current Stimulation (tDCS) to Improve Communicative Efforts, Speech, Language and Related Cognitive Functions in Individuals With Autism
- ClinicalTrials.gov ID
- NCT01603225
- Acronym / sponsor ID
- NA_00042345
- Conditions
- Autism Spectrum Disorders
- Keywords
- Autism, tDCS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 26 Dec 2016 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 22 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autism | – | Procedure: Transcranial Direct Current Stimulation (tDCS)Individuals with autism will have either Anodal, Cathodal, or Sham Transcranial Direct Current Stimulation (tDCS). |
Who may qualify
- Ages
- 14 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Peripheral blindness or deafness
- Any implanted metal device (precludes use of tDCS)
- Any implanted cardiac pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Autism |
Primary outcome
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
Related trials for Autism Spectrum Disorders
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
RecruitingPhase 2
TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS
Autism Disorder
Not yet recruitingObservational study
EEG As a Genetic Selection Lever in Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Gordon, M.D., Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorders, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Picture naming accuracy (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.