Clinical trial NCT04963803: Improving Aphasia Using Electrical Brain Stimulation
Official title: Improving Aphasia Outcomes Through tDCS-Mediated Attention Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Aphasia
Keywords: tDCS
attention
language
speech-language therapy
Lead sponsor: Syracuse University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2021-07-15
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in auditory comprehension on Language Specific Attention Treatment Probe Task
timeFrame: baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks
Secondary outcomes:
measure: Change from baseline on Continuous Performance Test
timeFrame: baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks
measure: Change from baseline on Attention Network Test
timeFrame: baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks
measure: Change from baseline on The Scenario Test
timeFrame: baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks
measure: Change from baseline on an Auditory Digit Span Task
timeFrame: baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks
measure: Change from baseline on The Revised Token Test
timeFrame: baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse University
state: New York
Study officials:
References:
citation: Peach RK, Nathan MR, Beck KM. Language-Specific Attention Treatment for Aphasia: Description and Preliminary Findings. Semin Speech Lang. 2017 Feb;38(1):5-16. doi: 10.1055/s-0036-1597260. Epub 2017 Feb 15.
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