AphasiaNCT01602263
Transcranial Direct Current Stimulation (tDCS) and Cognitive Processing
An observational study of Aphasia and Autism, 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. 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphasia, Autism, Schizophrenia
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Surgery or procedure
- How many people
- 307 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to 2 Mar 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 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Eligibility Criteria by Study Group
Normal Controls Inclusion Criteria:
- Right handed (as determined by the Edinburgh battery)
- English as native language
Normal Controls Exclusion Criteria:
- 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
Aphasia Group Inclusion Criteria:
- Right handed (as determined by the Edinburgh battery)
- English as native language
- History of acquired left-hemisphere dysfunction
Aphasia Group Exclusion Criteria:
- Appreciable deficits in hearing
- Schizophrenia, bipolar disorder, or major depression
- Appreciable accent
- Language-based learning disorder
- Any implanted metal device
- Any implanted cardiac pacemaker
- Mini-Mental State Exam < 21/27 (omitting naming \& items)
- Estimated verbal intelligence < 70
Schizophrenia/First-degree Family Members Inclusion Criteria:
- Right handed (as determined by the Edinburgh battery)
- English as native language
- Diagnosis of schizophrenia (SZ) or bipolar disorder (BD)
- First degree family member of individual with SZ or BD
Schizophrenia/First-degree Family Members Exclusion Criteria:
- Appreciable deficits in hearing
- Appreciable accent
- Any implanted metal device (precludes use of tDCS)
- Any implanted cardiac pacemaker
- Dementia or Mini-Mental State Exam < 24
- Estimated verbal intelligence < 70
High-functioning Autism Inclusion Criteria:
- Right handed (as determined by the Edinburgh battery)
- English as native language
- Diagnosis of High-functioning autism (i.e., Asperger's)
High-functioning Autism Exclusion Criteria:
- Appreciable deficits in hearing
- Schizophrenia, bipolar disorder, or major depression
- Appreciable accent
- Any implanted metal device
- Any implanted cardiac pacemaker
- Dementia or Mini-Mental State Exam < 24
- Estimated verbal intelligence < 70
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: Transcranial Direct Current Stimulation (tDCS)and Cognitive Processing
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.
Read the detailed description
Participants enrolled into this study may be asked to do the following:
- Grant permission for the researchers to view medical records associated with their language/cognitive difficulties (if applicable.
- Complete a questionnaire, provide a health history, and take some pencil-and-paper tests of problem-solving and memory in order to verify eligibility to participate and to able to safely undergo the experimental procedures.
- Complete several tasks (i.e., saying words out loud, naming objects, drawing designs, remembering lists of words, searching for images or letters, and/or completing puzzles) based upon a number of cognitive functions such as language, memory, vision, processing, and perception.
- 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.
- Participation in several study conditions. The exact conditions and their order will be randomized. Under some conditions, participants may receive active stimulation (tDCS) and under other conditions, they may receive sham stimulation.
- The experimental sessions will last approximately 2 hours and participants may be asked to have more than one testing session in a day or to return for additional sessions.
- Have a Magnetic Resonance Imaging (MRI) brain scan.
- Conditions
- Aphasia, Autism, Schizophrenia
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- Normal cognitive function, Aphasia, Autism, Schizophrenia
- Medical subject headings
- Aphasia, Autistic Disorder, Schizophrenia
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
Anodal, Cathodal or Sham tDCS.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Healthy Controls with no known cognitive impairment will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indices of cognitive function
Measured: The average time frame is 1 hour
Secondary outcomes (2)
Persistence of cognitive enhancements following tDCS
Measured: The average time frame is 1 hour
Initiation, endurance and cessation of skin sensations caused by tDCS
The initiation, endurance and cessation of skin sensations caused by tDCS will be examined in order to develop a more effective blinding procedure.
Measured: The average time frame is 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startJan 2009
- Primary completion23 Dec 2017
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 307 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
- NCT01602263
- Sponsor's protocol ID
- NA_00015657
- Other IDs
- 15657
- Status last verified
- Mar 2023
- First submitted
- 14 May 2012
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28775825Vannorsdall 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.
PubMed 27008245
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS)and Cognitive Processing
- ClinicalTrials.gov ID
- NCT01602263
- Acronym / sponsor ID
- NA_00015657
- Conditions
- Aphasia, Autism, Schizophrenia
- Keywords
- Normal cognitive function, Aphasia, Autism, Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- 23 Dec 2017 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 18 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. 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.
Detailed description
Participants enrolled into this study may be asked to do the following:
- Grant permission for the researchers to view medical records associated with their language/cognitive difficulties (if applicable.
- Complete a questionnaire, provide a health history, and take some pencil-and-paper tests of problem-solving and memory in order to verify eligibility to participate and to able to safely undergo the experimental procedures.
- Complete several tasks (i.e., saying words out loud, naming objects, drawing designs, remembering lists of words, searching for images or letters, and/or completing puzzles) based upon a number of cognitive functions such as language, memory, vision, processing, and perception.
- 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.
- Participation in several study conditions. The exact conditions and their order will be randomized. Under some conditions, participants may receive active stimulation (tDCS) and under other conditions, they may receive sham stimulation.
- The experimental sessions will last approximately 2 hours and participants may be asked to have more than one testing session in a day or to return for additional sessions.
- Have a Magnetic Resonance Imaging (MRI) brain scan.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Procedure: Transcranial Direct Current Stimulation (tDCS)Healthy Controls with no known cognitive impairment will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS. |
| Individuals with schizophrenia | – | Procedure: Transcranial Direct Current Stimulation (tDCS)Individuals with schizophrenia and first-degree relatives will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS. |
| Individuals with aphasia | – | Procedure: Transcranial Direct Current Stimulation (tDCS)Individuals with aphasia will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS. |
| Individuals with high-functioning autism | – | Procedure: Transcranial Direct Current Stimulation (tDCS)Individuals with high-functioning autism will have Transcranial Direct Current Stimulation (tDCS) administered and receive either Anodal, Cathodal or Sham tDCS. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
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)Anodal, Cathodal or Sham tDCS. | Procedure or surgery | Controls, Individuals with aphasia, Individuals with high-functioning autism, Individuals with schizophrenia |
Primary outcome
Indices of cognitive function
Time frame: The average time frame is 1 hour
2 secondary outcomes
Persistence of cognitive enhancements following tDCS
Time frame: The average time frame is 1 hour
Initiation, endurance and cessation of skin sensations caused by tDCS
Time frame: The average time frame is 1 hour
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 7 Mar 2023.
- Derived from this study: PubMed 28775825van 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.
- Derived from this study: PubMed 27008245Vannorsdall 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.
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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 Aphasia and Autism, 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?
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 7 Mar 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?
Indices of cognitive function (time frame: The average time frame is 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01602263, which also lists 2 linked publications.
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 7 Mar 2023.