Short and Long-term Responses of PD Symptoms to Earstim
Recruiting
N/A
Interventional Study
PARKINSON DISEASE (Disorder)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 44 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Stoparkinson Healthcare Systems LLC · Industry
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About This Trial
This is a prospective, multicenter, randomized, two-period study designed to evaluate the safety and effectiveness of the EarStim System for intermittent relief of motor symptoms in patients with Parkinson's disease experiencing wearing-off phenomena. Adult patients with moderate to severe Parkinson's disease (MDS-UPDRS Part III score ≥33) receiving oral dopaminergic therapy will be enrolled. Peri…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Patients fulfilling the following criteria are eligible for participation:
* Subject must be ≥44 years of age.
* Subject has PD and is on stable carbidopa/levodopa therapy for at least four weeks prior to enrollment in the study.
* Subject must be willing and able to refrain fr…
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