Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia
- Conditions
- Post-stroke Aphasia
- Interventions
- Device: TNM(trademark) - thermoneuromodulation
- Registration Number
- NCT02270866
- Lead Sponsor
- Scion NeuroStim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- >6 months post-stroke (ischemic or hemorrhagic)
- receptive or expressive aphasia
- little or no improvement in language ability in the preceding 3 months
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TNM(trademark) - thermoneuromodulation 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.
- Primary Outcome Measures
Name Time Method Measure and quantify any improvements in verbal fluency at the end of a 3-month Tx period 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
Name Time Method Mood & QoL 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.
Gait and posture 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.
Heart rate variability (HRV) 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.
Durability of gains 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.
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States