NCT02270866CompletedNot Applicable
Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia
Scion NeuroStim2 sites in 1 country9 target enrollmentStarted: October 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 2
- Primary Endpoint
- Measure and quantify any improvements in verbal fluency at the end of a 3-month Tx period
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •>6 months post-stroke (ischemic or hemorrhagic)
- •receptive or expressive aphasia
- •little or no improvement in language ability in the preceding 3 months
Exclusion Criteria
- •persons under the age of 18 or over the age of 75
- •patients with pure receptive aphasia
- •co-morbid CNS disease
- •primary motor/oral apraxia
- •pregnant or nursing women
- •have a history of unstable mood disorder or unstable anxiety disorder or psychosis
- •use of a hearing aid
- •have a cochlear implant
- •have a diagnosed vestibular dysfunction
- •abuse alcohol or other drugs
- •have had eye surgery within the previous three months or ear surgery within the previous six months
- •have active ear infections or a perforated tympanic membrane
- •have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
- •Though not excluded, patients taking anti-histamines or anti-nausea drugs will be encouraged not to take such medications within four hours prior to a CVS treatment. The Investigator should review other medications taken by the patient with properties that mimic anti-nausea or anti-dizziness drugs as these may reduce responsiveness of the vestibular system to caloric stimulation.
Outcomes
Primary Outcomes
Measure and quantify any improvements in verbal fluency at the end of a 3-month Tx period
Time Frame: after completing 84 days of device use
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.
Secondary Outcomes
- Mood & QoL(after completing 84 days of device use)
- Gait and posture(after completing 84 days of device use)
- Heart rate variability (HRV)(after completing 84 days of device use)
- Durability of gains(3 months after the completion of therapy)
Investigators
Study Sites (2)
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