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| Name | Class |
|---|---|
| Eric Sorenson Motor Speech Program at Brooks Rehabilitation | UNKNOWN |
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The goal of this research study is to evaluate a novel approach to improving speech recovery in those with acquired apraxia of speech. We will enroll participants with apraxia of speech resulting from stroke or brain injury to complete several tasks and intervention. Testing will take place four times over the course of the study and intervention will take place 5 days a week for 16 weeks. Overall, you can expect to spend up to 17 weeks participating in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | non-invasive vagus nerve stimulation is administered alongside standard intervention |
|
| Treatment B | Placebo Comparator | sham stimulation is administered alongside standard intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| taVNS | Device | active vagus nerve stimulation |
| |
| sham taVNS |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Frequency and severity of adverse events will be monitored and evaluated for severity and impact on attrition. | 6 months |
| Compliance | Percentage of the population that remains engaged in the study and completes all stimulation sessions. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in speech production scores | Primary outcomes for this aim include the learning trajectory over 8 weeks of speech therapy as measured by weekly probes and the WAB when intervention is combined with taVNS versus control stimulation to determine the effect of taVNS on re-learning motor speech plans and the trajectory of motor speech recovery. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooks Rehabilitation Clinical Research Center | Jacksonville | Florida | 32216 | United States |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D001072 | Apraxias |
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| D007802 | Language |
| D013060 | Speech |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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| Device |
sham vagus nerve stimulation |
|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011596 | Psychomotor Disorders |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D003142 | Communication |
| D001519 | Behavior |
| D014705 | Verbal Behavior |