NCT01603225

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2012

Completed
3.4 years until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2016

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

1.2 years

First QC Date

May 17, 2012

Last Update Submit

February 22, 2023

Conditions

Keywords

AutismtDCS

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Autism

Individuals with autism will have either Anodal, Cathodal, or Sham Transcranial Direct Current Stimulation (tDCS).

Procedure: Transcranial Direct Current Stimulation (tDCS)

Interventions

Delivery of transcranial direct current stimulation for 30-60 minutes or sham stimulation.This will be administered by two or more similar devices.

Autism

Eligibility Criteria

Age14 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Peripheral blindness or deafness
  • Any implanted metal device (precludes use of tDCS)
  • Any implanted cardiac pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology; Cognitive Neurology/Neuropsychology

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Barry Gordon, M.D., Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2012

First Posted

May 22, 2012

Study Start

October 1, 2015

Primary Completion

December 26, 2016

Study Completion

February 21, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02

Locations