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This is a single site, open label study with a single arm designed to assess the feasibility of use of caloric vestibular stimulation (CVS) in patients with post-stroke aphasia. CVS is delivered via a portable, non-invasive device. Both language and movement assessments are made.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caloric Vestibular Stimulation (CVS) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNM Device | Device | The device is worn like a music headset and the patient lies on a wedge pillow while the device is active. Each session lasts under 20 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure and quantify any improvements in verbal fluency at the end of a 3-month Tx period | At the end of the 84 day period of device use, the patient's verbal fluency will be compared with the baseline level to assess any improvement. Boston Diagnostic Aphasia exam, Hopkins verbal learning test, oral symbol digit modality test, oral trail marking test. | after completing 84 days of device use |
| Measure | Description | Time Frame |
|---|---|---|
| Mood & QoL | At the end of the 84 day period of device use, the patient's mood will be compared with the baseline scores to assess any improvement: Patient Health Questionnaire-9, Beck Depression Inventory, and for QoL: Stroke impact scale (short form), Everyday Cognition. | after completing 84 days of device use |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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| Gait and posture |
At the end of the 84 day period of device use, the patient's gait and posture will be compared with the baseline levels to assess any improvement. This is a blended measure employing Timed Up & Go and a 10-meter walk. |
| after completing 84 days of device use |
| Heart rate variability (HRV) | At the end of the 84 day period of device use, the patient's HRV values will be compared with those from the baseline period to assess any improvement. | after completing 84 days of device use |
| Durability of gains | Three months after the completion of the therapy period, measurements of verbal fluency, mood & QOL, gait & posture and HRV will be completed and compared with the values from the end of the treatment period to assess durability of any gains. | 3 months after the completion of therapy |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |