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Clinical Trials/NCT02270866
NCT02270866
Completed
Not Applicable

Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia

Scion NeuroStim1 site in 1 country9 target enrollmentOctober 2014
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ConditionsPost-stroke Aphasia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-stroke Aphasia
Sponsor
Scion NeuroStim
Enrollment
9
Locations
1
Primary Endpoint
Measure and quantify any improvements in verbal fluency at the end of a 3-month Tx period
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
July 2016
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Scion NeuroStim
Responsible Party
Sponsor

Eligibility Criteria

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

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)

Study Sites (1)

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