Multicenter Study of Safety and Effectiveness of Auricular Muscle Zone Stimulation With the EarStim Novel Device for Parkinson's Disease

NCT07400731 NA RECRUITING

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.

Details

Lead sponsor	Stoparkinson Healthcare Systems LLC
Phase	NA
Status	RECRUITING
Enrolment	90
Start date	2026-03-12
Completion	2027-02

Conditions

• PARKINSON DISEASE (Disorder)

Interventions

• EarStim
• Sham device
• EarStim + Standard of care (SOC)
• Standard of Care (SOC)

Primary outcomes

• Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III scores — 40 minutes
  Comparison of reduction in the MDS-UPDRS Part III scores from pre-stimulation to 40 minutes post-stimulation between active and sham arms during Period A. 18 items, 0-4 rating scale (from normal to worse).
• Adverse events — From enrollment to the end of study at 90 days
  Frequency of all adverse events

Countries

Turkey (Türkiye)