Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia

Scion NeuroStim

Status

Completed

Conditions

Post-stroke Aphasia

Treatments

Device: TNM Device

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02270866

SNS-APH-01

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.