Stroke
Conditions
Brief 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.
Interventions
BEHAVIORALAphasia therapy
Aphasia therapy using a computerized scripting program
DEVICEAnodal tDCS
Anodal transcranial direct current stimulation using the Chattanooga Ionto device
DEVICESham tDCS
Sham transcranial direct current stimulation using the Chattanooga Ionto device
Sponsors
Pitkin Foundation
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age over 21 years 2. Ischemic left hemispheric stroke verified by imaging (CT or MRI) greater than 6 months ago 3. Residual non-fluent or anomic aphasia, with Western Aphasia Battery-Revised Aphasia Quotient score \<60 4. Fluent English speaker prior to stroke 5. Right-handed prior to stroke 6. Ability to give informed consent and understand the tasks involved.
Exclusion criteria
1. History of recurrent stroke, either ischemic or hemorrhagic, in the left middle cerebral artery territory 2. Imaging unavailable 3. Large middle cerebral artery infarct involving entire inferior division (temporo-parietal) territory 4. History of dementia prior to the stroke 5. History of seizure, prior electroconvulsive therapy, deep brain stimulators, or brain surgery 6. Social and/or personal circumstances that interfere with ability to return for therapy and assessment sessions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Percent Correct of Trained Scripts | From Baseline to up to 2 days post-training |
| Change in Words Per Minute of Trained Scripts | From Baseline to up to 2 days post-training |
Secondary
| Measure | Time frame |
|---|---|
| Change in Percent Correct of Trained Scripts | Baseline to 2 weeks and 4 weeks post-training |
| Change in Words Per Minute of Trained Scripts | Baseline to 2 weeks and 4 weeks post-training |
Other
| Measure | Time frame |
|---|---|
| Change in Percent Script Words Omitted | Baseline to immediate, 2 weeks, and 4 weeks post-training |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Includes participants who received anodal transcranial direct current stimulation (tDCS) or sham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Change in Percent Correct of Trained Scripts
Time frame: From Baseline to up to 2 days post-training
Population: Due to poor enrollment, data collection was not complete and therefore data was not analyzed. PI is now no longer at the institution.
Primary
Change in Words Per Minute of Trained Scripts
Time frame: From Baseline to up to 2 days post-training
Population: Due to poor enrollment, data collection was not complete and therefore data was not analyzed. PI is now no longer at the institution.
Secondary
Change in Percent Correct of Trained Scripts
Time frame: Baseline to 2 weeks and 4 weeks post-training
Population: Due to poor enrollment, data collection was not complete and therefore data was not analyzed. PI is now no longer at the institution.
Secondary
Change in Words Per Minute of Trained Scripts
Time frame: Baseline to 2 weeks and 4 weeks post-training
Population: Due to poor enrollment, data collection was not complete and therefore data was not analyzed. PI is now no longer at the institution.
Other Pre-specified
Change in Percent Script Words Omitted
Time frame: Baseline to immediate, 2 weeks, and 4 weeks post-training