Status:
COMPLETED
Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia
Lead Sponsor:
Scion NeuroStim
Conditions:
Post-stroke Aphasia
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- \>6 months post-stroke (ischemic or hemorrhagic)
- receptive or expressive aphasia
- little or no improvement in language ability in the preceding 3 months
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02270866
Start Date
October 1 2014
End Date
July 1 2016
Last Update
March 30 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705