StrokeNCT02461355
Transcranial Direct Current Stimulation for Post-Stroke Aphasia
A study testing Aphasia therapy and Anodal tDCS in people with Stroke, run by Columbia University at 1 site in United States.
Trial summary
This is a randomized, crossover design trial that will compare how anodal transcranial direct current stimulation (tDCS) versus sham tDCS administered during multiple sessions of scripting therapy affects the acquisition and retention of trained scripts. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Aphasia therapy and Anodal tDCS
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 21 years
- Ischemic left hemispheric stroke verified by imaging (CT or MRI) greater than 6 months ago
- Residual non-fluent or anomic aphasia, with Western Aphasia Battery-Revised Aphasia Quotient score <60
- Fluent English speaker prior to stroke
- Right-handed prior to stroke
- Ability to give informed consent and understand the tasks involved.
Who cannot join
- History of recurrent stroke, either ischemic or hemorrhagic, in the left middle cerebral artery territory
- Imaging unavailable
- Large middle cerebral artery infarct involving entire inferior division (temporo-parietal) territory
- History of dementia prior to the stroke
- History of seizure, prior electroconvulsive therapy, deep brain stimulators, or brain surgery
- Social and/or personal circumstances that interfere with ability to return for therapy and assessment sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Aphasia Therapy With Anodal Transcranial Direct Current Stimulation in Chronic Stroke Patients
This is a randomized, crossover design trial that will compare how anodal transcranial direct current stimulation (tDCS) versus sham tDCS administered during multiple sessions of scripting therapy affects the acquisition and retention of trained scripts.
- Conditions
- Stroke
- Being tested
- Aphasia therapy, Anodal tDCS, Sham tDCS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aphasia therapyBehavioural
Aphasia therapy using a computerized scripting program
Anodal tDCSDevice
Anodal transcranial direct current stimulation using the Chattanooga Ionto device
Sham tDCSDevice
Sham transcranial direct current stimulation using the Chattanooga Ionto device
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Experimental | Anodal tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions Receives: Behavioral: Aphasia therapy; Device: Anodal tDCS |
| Sham tDCS | Sham comparator | Sham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions Receives: Behavioral: Aphasia therapy; Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent Correct of Trained Scripts
Measured: From Baseline to up to 2 days post-training
Change in Words Per Minute of Trained Scripts
Measured: From Baseline to up to 2 days post-training
Secondary outcomes (2)
Change in Percent Correct of Trained Scripts
Measured: Baseline to 2 weeks and 4 weeks post-training
Change in Words Per Minute of Trained Scripts
Measured: Baseline to 2 weeks and 4 weeks post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Pitkin Foundation
- Responsible party
- Sponsor
- Investigators
- Tomoko Kitago, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461355
- Sponsor's protocol ID
- AAAO1700
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2015
- Last updated
- 9 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Aphasia Therapy With Anodal Transcranial Direct Current Stimulation in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT02461355
- Acronym / sponsor ID
- AAAO1700
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Pitkin Foundation
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Posted 9 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, crossover design trial that will compare how anodal transcranial direct current stimulation (tDCS) versus sham tDCS administered during multiple sessions of scripting therapy affects the acquisition and retention of trained scripts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Behavioral: Aphasia therapy, Device: Anodal tDCSAnodal tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions |
| Sham tDCS | Sham comparator | Behavioral: Aphasia therapy, Device: Sham tDCSSham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 21 years
- Ischemic left hemispheric stroke verified by imaging (CT or MRI) greater than 6 months ago
- Residual non-fluent or anomic aphasia, with Western Aphasia Battery-Revised Aphasia Quotient score <60
- Fluent English speaker prior to stroke
- Right-handed prior to stroke
Key exclusion criteria (6 listed)
- History of recurrent stroke, either ischemic or hemorrhagic, in the left middle cerebral artery territory
- Imaging unavailable
- Large middle cerebral artery infarct involving entire inferior division (temporo-parietal) territory
- History of dementia prior to the stroke
- History of seizure, prior electroconvulsive therapy, deep brain stimulators, or brain surgery
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 |
|---|---|---|
| Aphasia therapyAphasia therapy using a computerized scripting program | Behavioural | Anodal tDCS, Sham tDCS |
| Anodal tDCSAnodal transcranial direct current stimulation using the Chattanooga Ionto device | Device | Anodal tDCS |
| Sham tDCSSham transcranial direct current stimulation using the Chattanooga Ionto device | Device | Sham tDCS |
Primary outcome
Change in Percent Correct of Trained Scripts
Time frame: From Baseline to up to 2 days post-training
Change in Words Per Minute of Trained Scripts
Time frame: From Baseline to up to 2 days post-training
2 secondary outcomes
Change in Percent Correct of Trained Scripts
Time frame: Baseline to 2 weeks and 4 weeks post-training
Change in Words Per Minute of Trained Scripts
Time frame: Baseline to 2 weeks and 4 weeks post-training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Acute Ischemic Stroke
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Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
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Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
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The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
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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.
Tomoko Kitago, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aphasia therapy and Anodal tDCS in people with Stroke, run by Columbia 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 9 May 2019. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Percent Correct of Trained Scripts (time frame: From Baseline to up to 2 days post-training). 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 9 May 2019.