NCT01602263

Brief Summary

This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities. In this research, battery powered device is used to deliver very weak electrical current to the surface of the scalp while participants complete cognitive tasks. Our aim is to find out whether tDCS will improve task performance in both healthy adults and those with neurological impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2017

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

9 years

First QC Date

May 14, 2012

Last Update Submit

March 3, 2023

Conditions

Keywords

Normal cognitive functionAphasiaAutismSchizophrenia

Outcome Measures

Primary Outcomes (1)

  • Indices of cognitive function

    The average time frame is 1 hour

Secondary Outcomes (2)

  • Persistence of cognitive enhancements following tDCS

    The average time frame is 1 hour

  • Initiation, endurance and cessation of skin sensations caused by tDCS

    The average time frame is 1 hour

Study Arms (4)

Controls

Healthy Controls with no known cognitive impairment will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS.

Procedure: Transcranial Direct Current Stimulation (tDCS)

Individuals with schizophrenia

Individuals with schizophrenia and first-degree relatives will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS.

Procedure: Transcranial Direct Current Stimulation (tDCS)

Individuals with aphasia

Individuals with aphasia will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS.

Procedure: Transcranial Direct Current Stimulation (tDCS)

Individuals with high-functioning autism

Individuals with high-functioning autism will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS.

Procedure: Transcranial Direct Current Stimulation (tDCS)

Interventions

Anodal, Cathodal or Sham tDCS.

ControlsIndividuals with aphasiaIndividuals with high-functioning autismIndividuals with schizophrenia

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

You must also belong to one of three groups to join this study: 1. Healthy adults with no known deficits in cognition 2. Adults with acquired language problems (i.e., stroke, mental illness) 3. Adults with developmental language delays

You may qualify if:

  • Right handed (as determined by the Edinburgh battery)
  • English as native language

You may not qualify if:

  • Appreciable deficits in hearing
  • Appreciable problems with articulation
  • Schizophrenia, bipolar disorder, or major depression
  • Appreciable accent
  • Any neurological disorder associated with cognitive impairment or neuroanatomic abnormality
  • Language-based learning disorder
  • Any implanted metal device (precludes use of tDCS)
  • Any implanted cardiac pacemaker
  • Dementia or Mini-Mental State Exam \< 24
  • Estimated verbal intelligence \< 70
  • Right handed (as determined by the Edinburgh battery)
  • English as native language
  • History of acquired left-hemisphere dysfunction
  • Appreciable deficits in hearing
  • Schizophrenia, bipolar disorder, or major depression
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology; Cognitive Neurology/Neuropsychology

Baltimore, Maryland, 21231, United States

Location

Related Publications (2)

  • van Steenburgh JJ, Varvaris M, Schretlen DJ, Vannorsdall TD, Gordon B. Balanced bifrontal transcranial direct current stimulation enhances working memory in adults with high-functioning autism: a sham-controlled crossover study. Mol Autism. 2017 Jul 28;8:40. doi: 10.1186/s13229-017-0152-x. eCollection 2017.

  • Vannorsdall TD, van Steenburgh JJ, Schretlen DJ, Jayatillake R, Skolasky RL, Gordon B. Reproducibility of tDCS Results in a Randomized Trial: Failure to Replicate Findings of tDCS-Induced Enhancement of Verbal Fluency. Cogn Behav Neurol. 2016 Mar;29(1):11-7. doi: 10.1097/WNN.0000000000000086.

MeSH Terms

Conditions

AphasiaAutistic DisorderSchizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAutism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic 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
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 18, 2012

Study Start

January 1, 2009

Primary Completion

December 23, 2017

Study Completion

March 2, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations