NeuroCuple to Mitigate Post-Wisdom Teeth Extraction Opioid Risks
United States120 participantsStarted 2026-06-30
Plain-language summary
This is a randomized (1:1), placebo-controlled clinical trial that will examine the feasibility and effectiveness of a 2-day application of the NeuroCuple device for pain relief and reduction of opioid use following wisdom teeth extraction. The primary objectives are to determine whether the active NeuroCuple reduces postoperative pain and decreases opioid consumption compared to a sham (placebo) device. A total of 120 participants will be enrolled over a 1-year period and randomized to receive either the active device or an identical-appearing placebo device without the captor array layer.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Males and females of all races and ethnicity
✓. \>18 to 50 years
✓. Healthy based on medical history
✓. Scheduled for elective extraction of one or more partially or fully impacted mandibular third molars
✓. Able to understand and sign the informed consent form
✓. Willing and able to comply with all study procedures
✓. Available for the duration of the study
✓. Able to understand the directions for data gathering instruments
Exclusion criteria
✕. Children (\< 18 years of age)
✕. T-score ≥ 60 in any of the three PROMIS measures (i.e., sleep, anxiety, and depression)
✕. Other concomitant surgery being performed in addition to third molar extraction