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Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia

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ClinicalTrials.gov Identifier: NCT02270866
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : October 18, 2016
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Scion NeuroStim

Brief Summary:
This is a pilot study with a single active treatment arm. The study is designed to assess the efficacy of a portable, non-invasive neuromodulation system for the treatment of post-stroke aphasia. Both language and movement assessments will be made.

Condition or disease Intervention/treatment Phase
Post-stroke Aphasia Device: TNM(trademark) - thermoneuromodulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia
Study Start Date : October 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: TNM(trademark) - thermoneuromodulation
TNM (thermoneuromodulation device). A standardized active thermal neuromodulation waveform will be used for all patients. The device is noninvasive and does not use electrical stimulation.
Device: TNM(trademark) - thermoneuromodulation
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 Outcome Measures :
  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 Outcome Measures :
  1. Mood [ 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

  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 [ 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 any 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.

  5. Quality of Life [ Time Frame: after completing 84 days of device use ]
    At the end of the 84 day period of device use, the patient's QOL will be compared with the baseline scores to assess any improvement. Stroke impact scale (short form), Everyday Cognition.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270866


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Scion NeuroStim
Duke University

Responsible Party: Scion NeuroStim
ClinicalTrials.gov Identifier: NCT02270866     History of Changes
Other Study ID Numbers: SNS-APH-01
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Scion NeuroStim:
aphasia
stroke

Additional relevant MeSH terms:
Aphasia
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms