Aphasia, Stroke
Conditions
Keywords
transcranial direct current stimulation, stroke, aphasia, speech therapy, neurorehabilitation, neuromodulation, language function, neuroplasticity, neuroimaging, EEG, MRI, genetics, language disorders
Brief summary
Up to 40% of stroke survivors suffer from aphasia, making recovery of language abilities a top priority in stroke rehabilitation. Conventional speech and language therapy may have limited effectiveness. Leveraging multimodal data (behavioral, neuroimaging, and genetics), this study aims to 1) evaluate the efficacy of combining tDCS with speech therapy, 2) examine neural changes associated with recovery, 3) identify factors influencing response to treatment.
Detailed description
Approximately one million people in the United States are living with aphasia, an acquired neurological disorder affecting the ability to use and/or understand language. This communication impairment affects up to 40% of stroke patients. Stroke victims usually prioritize speaking, writing, and walking as the three most important rehabilitation goals, two of these goals therefore involving communication. Conventional speech therapy strategies have nevertheless limited effectiveness in post-stroke aphasia. Indeed, approximately half of those affected will remain in this state despite intensive speech therapy. Effective novel treatment is therefore warranted to improve recovery in these patients. Recent evidence suggests that transcranial direct current stimulation (tDCS), a non-invasive, low-cost neuromodulation technique, applied in conjunction with speech therapy may be more effective in promoting language recovery than behavioral intervention alone. A double-blind quasi-randomized controlled study will be carried out in chronic post-stroke aphasics. Participants will be assigned to either the tDCS group or to the sham (placebo) group and will receive 20 minutes of concurrent speech and language therapy by a trained speech therapist over five consecutive days. Behavioral, EEG, and MRI data will be acquired within one week before and after intervention. Genetic samples will be collected once. Secondary behavioral outcome measures will be performed again 3 months following tDCS/sham intervention to assess long-term benefits.
Interventions
DEVICEtDCS
Anodal or sham tDCS will be applied to the scalp.
BEHAVIORALSpeech and language therapy
A trained speech pathologist will administer the speech and language therapy.
Sponsors
Casa Colina Hospital and Centers for Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The only person knowing about this assignment will be the Principal Investigator.
Intervention model description
double-blind quasi-randomized controlled design
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Between ages 18-85 * At least 12 months post stroke * Diagnosed with aphasia due to ischemic or hemorrhagic stroke * English speaking * Right handed prior to stroke
Exclusion criteria
* Nonverbal * Other neurological diseases/disorders * Not MRI-compatible (e.g. claustrophobia, metal implants in the head)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Western Aphasia Battery-Revised scores | At baseline and at week 3 | WAB-R is an instrument for assessing the language function of adults with suspected neurological disorders as a result of a stroke. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) | At baseline, at week 3, and at week 17 | PROMIS is used to assess physical, mental, and social health. |
| Change in Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) | At baseline, at week 3, and at week 17 | The SAQOL-39 is used to assess health-related quality of life in people with long-term aphasia. |
| Change in Communication Outcomes after Stroke (COAST) | At baseline, at week 3, and at week 17 | The COAST is used to assess self-perceived communication effectiveness for people with aphasia. |
| Change in resting state Electroencephalograph (EEG) signals | At baseline and at week 3 | Using a B-Alert wireless EEG system, we will perform eyes-open resting-state EEG recordings to assess power spectral density changes. |
| Change in Test of Nonverbal Intelligence (TONI-4) | At baseline and at week 3 | TONI-4 is a language-free intelligence test for evaluating those with limited language ability. |
| Change in Magnetic Resonance Imaging (MRI) | At baseline and at week 3 | MRI scans will be acquired on a Siemens Magnetom Verio 3T Scanner at Casa Colina Imaging Center to assess structural changes. |
Countries
United States
Outcome results
None listed