Multicenter Study of Safety and Effectiveness of Auricular Muscle Zone Stimulation With the EarStim Novel Device for Parkinson's Disease
- Trial ID
- NCT07400731
- Official Title
- Multicenter Study of Safety and Effectiveness of Auricular Muscle Zone Stimulation With the EarStim Novel Device for Parkinson's Disease
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Stoparkinson Healthcare Systems LLC
- Study Type
- INTERVENTIONAL
- Enrollment
- 90 participants
- Conditions
- PARKINSON DISEASE (Disorder)
- Interventions
- EarStim, Sham device, EarStim + Standard of care (SOC), Standard of Care (SOC)
Plain-Language Summary
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. Period A is a randomized, double-blind, sham-controlled phase conducted in a clinical setting. Period B is an unblinded, standard-of-care-controlled phase evaluating the effectiveness of the EarStim System during home use over 90 days.
Locations
- Koc University Hospital, Istanbul, Turkey (Türkiye)
- Şişli Hamidiye Etfal Research and Training Hospital, Istanbul, Turkey (Türkiye)
Frequently Asked Questions
- What is this trial testing?
- This trial is studying EarStim. 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. Period A is a randomized, double-blind, sham-controlled phase conducted in a clinical setting. Period B is an unblinded, standard-of-care-controlled phase evaluating the effectiveness of the EarStim System during home use over 90 days.
- Who can participate?
- Participants must be at least 44 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 10 months.