CompletedInterventionalNot ApplicableUpdated Mar 21, 2017
A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease | NCT02134795 | Trialant
TerminatedInterventionalNot ApplicableUpdated May 2, 2025
A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
ClinicalTrials.gov ID
NCT02134795
Lead Sponsor
Scion NeuroStimINDUSTRY
Overall Status
Terminated
Study Type
Interventional
Phase
Not Applicable
Enrollment
6Actual
Last Update Posted
May 2, 2025Actual
Start Date
May 2014
Primary Completion Date
Sep 2014Actual
Completion Date
Sep 2014Actual
Brief Summary
This is a single-center, open label study evaluating the acute effect of caloric vestibular stimulation on UPDRS motor scores in Parkinson's Disease patients.
Parkinson's Disease
TNM Device
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient should have a UPDRS motor score of 14 (off medication) or higher (mild to moderate)
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:
Women who are pregnant or nursing
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