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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
9
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.
Duke University Medical Center
Durham, North Carolina, United States
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.
Time frame: after completing 84 days of device use
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.
Time frame: after completing 84 days of device use
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months after the completion of therapy
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