A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
NCT ID: NCT02134795
Last Updated: 2025-05-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2014-05-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Caloric Vestibular Stimulation (CVS)
Mild to moderate Parkinson's disease subjects will up to 3 sessions of 19 minutes each with the TNM Device during as many as 2 study visits: 2 sessions separated by 1 hour during the 1st study visit and 1 CVS session during a 2nd study visit.
TNM Device
The noninvasive device is worn like a music headset and the patient lies back on a wedge pillow while the device is active. Each session lasts under 20 minutes.
Interventions
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TNM Device
The noninvasive device is worn like a music headset and the patient lies back on a wedge pillow while the device is active. Each session lasts under 20 minutes.
Eligibility Criteria
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Inclusion Criteria
* Patient should have a Hoehn \& Yahr staging of 1 to 3 (mild to moderate)
* Patient must be an adult (18 years of age or older)
Exclusion Criteria
* have a history of significant cardiovascular disease (no pacemakers)
* have a history of unstable mood disorder or unstable anxiety disorder or psychosis
* use a hearing aid
* have a cochlear implant
* have been diagnosed with neurological disease other than Parkinson's disease. No atypical parkinsonism.
* 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
18 Years
ALL
No
Sponsors
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Scion NeuroStim
INDUSTRY
Responsible Party
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Locations
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Duke University Health System
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00053320
Identifier Type: -
Identifier Source: org_study_id
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