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Completed

NCT Number: NCT02270866

Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia

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.

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Key information

Conditions

Post-stroke Aphasia Aphasia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TNM device

Device

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.

Primary outcomes

  1. 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

  1. Mood & QoL

    Time frame: after completing 84 days of device use

    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.

  2. Gait and posture

    Time frame: after completing 84 days of device use

    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.

  3. Heart rate variability (HRV)

    Time frame: after completing 84 days of device use

    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.

  4. Durability of gains

    Time frame: 3 months after the completion of therapy

    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.

Sponsors and collaborators

Lead sponsor

Scion NeuroStim

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2014
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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