Aphasia, Stroke
Conditions
Keywords
stroke, aphasia, CVA, apraxia, cerebrovascular accident, cerebral stroke, speech therapy, aphasia therapy, non-invasive brain stimulation, transcranial direct current stimulation, tDCS
Brief summary
The purpose of this study is to determine if non-invasive brain stimulation (transcranial direct current stimulation) delivered prior to language therapy will improve word-finding in individuals with aphasia who are 6 months or greater post-stroke.
Interventions
DEVICEtranscranial direct current stimulation
Soterix 1x1 anodal tDCS
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sequence of stimulation conditions was randomized across subjects.
Intervention model description
All participants received both stimulation conditions (active tDCS + computerized naming therapy and sham tDCS + computerized naming therapy), separated by a 1-week washout period.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years of age 2. First single focal unilateral left hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior 3. Pre-morbidly right handed 4. Pre-morbidly fluent English speaker 5. Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist) 6. A baseline Aphasia Quotient score between 10 to 94 out of 100 points on the Western Aphasia Battery (neither completely without language comprehension/expression nor fully recovered from aphasia).
Exclusion criteria
1. Ongoing use of CNS-active medications 2. Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications 3. Presence of additional potential tDCS risk factors: * Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.) * Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system * Metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation) * A history of medication-resistant epilepsy in the family * Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months 4. Pregnancy in women, as determined by self-report
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Picture-naming Accuracy Score | baseline, discharge | The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS). |
Countries
United States
Participant flow
Pre-assignment details
All participants received both the active and sham tDCS conditions, and sequence of stimulation conditions was randomized across participants.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Crossover design study: All participants were randomized to receive one single 20 min session of anodal tDCS and 1 single session of sham tDCS followed by computerized naming therapy. Sequence of stimulation conditions was counterbalanced across participants with a 1 week washout period in between conditions. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 13 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Mean Change in Picture-naming Accuracy Score
The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).
Time frame: baseline, discharge
Population: All participants received one dose of each intervention and completed all study visits. They were consequently all included in the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anodal tDCS | Mean Change in Picture-naming Accuracy Score | Mean Score at Discharge(out of 75) | 51.33 score | Standard Deviation 17.79 |
| Anodal tDCS | Mean Change in Picture-naming Accuracy Score | Mean Change from Baseline | 5.25 score | Standard Deviation 4.85 |
| Sham tDCS | Mean Change in Picture-naming Accuracy Score | Mean Score at Discharge(out of 75) | 51.00 score | Standard Deviation 18.4 |
| Sham tDCS | Mean Change in Picture-naming Accuracy Score | Mean Change from Baseline | 5.92 score | Standard Deviation 5.21 |
p-value: 0.694wilcoxon sign-ranked test