Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia

Conditions
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Post-stroke Aphasia

Intervention / Treatment
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* Device: TNM(trademark) - thermoneuromodulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNM(trademark) - thermoneuromodulation<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure and quantify any improvements in verbal fluency at the end of a 3-month Tx period | 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. | after completing 84 days of device use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood | 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 | after completing 84 days of device use | 
| gait and posture | 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. | after completing 84 days of device use | 
| heart rate variability | 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. | after completing 84 days of device use | 
| durability of any gains | 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. | 3 months after the completion of therapy | 
| Quality of Life | 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. | after completing 84 days of device use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aphasia, stroke