Aphasia, Stroke
Conditions
Keywords
tDCS, attention, language, speech-language therapy
Brief summary
Language and communication are essential for almost every aspect of human life, but for people who have aphasia, a language processing disorder that can occur after stroke or brain injury, even simple conversations can become a formidable challenge. Speech and language therapy can help people recover their language ability, but often requires months or even years of therapy before a person is able to overcome these challenges. This research will investigate non-invasive brain stimulation as a way to enhance the effects of speech and language therapy, which may ultimately lead to better and faster recovery from stroke and aphasia. The investigators hypothesize that participants with aphasia who receive speech and language therapy paired with active electrical brain stimulation will improve significantly more on a language comprehension task than those who receive speech and language therapy paired with sham stimulation.
Interventions
DEVICEActive transcranial direct current stimulation (tDCS)
Active transcranial direct current stimulation will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session for 10 sessions.
DEVICESham transcranial direct current stimulation (tDCS)
Sham transcranial direct current stimulation will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session. Participants in this arm will receive sham stimulation for 10 sessions.
BEHAVIORALLanguage Specific Attention Treatment
This is a specific type of speech-language therapy that focuses on simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this treatment.
Sponsors
Syracuse University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older. 2. No diagnosis of neurological disorder (other than stroke). 3. No diagnosis of psychiatric disorder. 4. No seizure within the past 6 months. 5. Not pregnant. 6. In chronic phase of recovery, defined as at least 6 months post-stroke. 7. Not undergoing speech and language therapy targeting auditory comprehension or attention for the duration of the study. 8. No metal implants in the head. 9. No unhealed skull fractures. 10. Onset of aphasia related to left hemisphere stroke. 11. Damaged brain tissue from stroke does not overlap with left hemisphere dorsolateral prefrontal cortex. 12. Mild to moderate aphasia. 13. Cognitive ability minimally within functional limits. 14. Able to pass vision and hearing screening (with use of corrective aids if needed; eyeglasses, hearing aids). 15. Willing to allow audio-recording of study sessions.
Exclusion criteria
1. Younger than 18 years old. 2. Diagnosis or history of neurological disorder other than stroke. 3. Diagnosis or history of psychiatric disorder. 4. History of seizures within the past 6 months. 5. Pregnant. 6. \<6 months post-stroke (however, if this is only exclusionary criterion met, participant can be re-evaluated at the 6-month mark if still interested in the study) 7. Currently undergoing speech and language therapy targeting auditory comprehension or attention. 8. Metal implants in the head. 9. Currently has a skull fracture. 10. Onset of aphasia related to etiology other than left hemisphere stroke. 11. Damaged brain tissue includes left hemisphere dorsolateral prefrontal cortex. 12. No aphasia or severe aphasia. 13. Cognitive ability below functional limits. 14. Unable to pass vision and/or hearing screening with use of corrective aids. 15. Unwilling to allow audio-recording of study sessions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Language Specific Attention Treatment Probe | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline | Measurement of auditory comprehension for untrained sentence-level stimuli. Participants listen to a sentence and are asked to answer comprehension questions about the sentence they heard. Results are reported as the percentage of correct responses out of the total number of items administered. Higher percentages indicate better performance and less auditory comprehension impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Performance Test | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline | Change in sustained attention as measured by mean reaction time on the Continuous Performance Test. Participants monitor a screen and press a button for all stimuli except a specific 'no-go' target. The value reported is the mean response time in milliseconds (ms) for correct 'go' trials; a decrease in time indicates improved processing speed. |
| Attention Network Test | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline | The Attention Network Test (ANT) is a computerized task that measures the efficiency of three distinct attentional networks: Alerting, Orienting, and Executive (Conflict) control. Alerting Network Score: Calculated by subtracting the mean reaction time (RT) of double-cue trials from no-cue trials. Range: -500ms to +500ms. Higher positive scores represent a greater alerting benefit. Orienting Network Score: Calculated by subtracting the mean RT of spatial-cue trials from center-cue trials. Range: -500ms to +500ms. Higher positive scores represent a greater orienting benefit. Conflict (Executive) Network Score: Calculated by subtracting the mean RT of congruent flanker trials from incongruent flanker trials. Range: -500ms to +1000ms. Lower scores represent better executive control and less interference from distracting stimuli. |
| Scenario Test | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline | The Scenario Test assesses daily life communication and discourse through 6 multi-modal scenarios presented via pictures. Participants are prompted to respond to specific communicative situations. Performance is scored based on the effectiveness of communication (verbal and non-verbal) for each item. Results are reported as the average percentage of correct communicative acts out of the total possible score. Range: 0% to 100%, where higher percentages indicate better functional communication and less severe impairment. |
| Revised Token Test | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline | The Revised Token Test assesses auditory comprehension battery; 5 subtests were administered that contributed to the total score. Results are reported as a mean of the 5 subtest scores. Range of scores is 1 to 15, higher scores represent better performance and less severe auditory comprehension impairment. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 10 |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 10 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 9 Participants |
| Western Aphasia Battery-Revised | 72 Raw score STANDARD_DEVIATION 26 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
None listed