Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DC021677-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
Not provided
Not provided
Not provided
The goal of this clinical trial is to determine if electrical brain stimulation applied to the front parts of the brain can help people who have had a stroke improve their fatigue, language, and attention. The main question it aims to answer is:
Researchers will compare active electrical stimulation to sham stimulation to see if the active stimulation does a better job at reducing fatigue and language deficits after stroke. Participants will be asked to complete fatigue, language, and cognitive testing before and after receiving 10 sessions of tDCS plus speech and language therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tDCS plus attention-focused language treatment | Experimental | active tDCS and attention focused language treatment will be administered |
|
| active tDCS plus sentence picture matching treatment | Active Comparator | active tDCS and sentence picture matching treatment will be administered |
|
| sham tDCS plus attention-focused language treatment | Sham Comparator | sham tDCS and attention focused language treatment will be administered |
|
| sham tDCS plus sentence picture matching treatment | Sham Comparator | sham tDCS and sentence picture matching treatment will be administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS (active) | Device | The investigators will administer active tDCS to left dorsolateral prefrontal cortex (DLPFC) during 10 sessions of behavioral treatment. For active tDCS, the current will slowly be increased to 2mA and applied for 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Interference and Severity Scale for Aphasia (FISS-A) | Scale from 1-7, higher scores mean more significant fatigue | baseline; within 1 week following the final treatment session; 3- month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Performance Test (CPT) | baseline; within 1 week following the final treatment session; 3- month follow-up | |
| Attention Network Test (ANT) | baseline; within 1 week following the final treatment session; 3- month follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ellyn Riley | Contact | 315-443-8688 | aphasia@syr.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
Data generated for this project will include participant demographic data, medical information related to the participant's stroke (e.g., date of stroke onset, lesion location), standardized test scores from language and cognitive tests (e.g., Western Aphasia Battery), and outcome measure data. All data will be de-identified.
Shared data and supporting information generated from this project will be made available as soon as possible, and no later than one year following the end of the funding period (11/30/2029). The duration of preservation and sharing of the data will be a minimum of 6 years after the end of the funding period.
Controlled access will not be used. The data that is shared will be shared by unrestricted download. All datasets that can be shared will be deposited in Open Science Framework. Open Science Framework provides searchable study-level metadata for dataset discovery. Open Science Framework assigns DOIs as persistent identifiers and has a robust preservation plan to ensure long-term access. Data will be discoverable online through standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset.
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D005221 | Fatigue |
| D001037 | Aphasia |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Attention-focused sentence comprehension treatment | Behavioral | This is a specific type of speech-language therapy that focuses on simultaneously improving auditory comprehension and behavioral attention. Participants will receive 10 sessions of this treatment. |
|
| Sentence comprehension treatment | Behavioral | This is a specific type of speech-language therapy that focuses on improving auditory comprehension . Participants will receive 10 sessions of this treatment. |
|
| tDCS (sham) | Device | The investigators will administer sham tDCS to left dorsolateral prefrontal cortex (DLPFC) during 10 sessions of behavioral treatment. For sham tDCS, the current will slowly be increased to 2mA over the course of 30 seconds and then immediately ramped back down to zero. |
|
|
| Sentence comprehension task | baseline; within 1 week following the final treatment session; 3- month follow-up |
| Syracuse University | Recruiting | Syracuse | New York | 13244 | United States |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |