Evaluating Whether a Nausea Band Reduces Symptoms in Those With Chronic Nausea Vomiting

Chronic nausea with or without vomiting is a debilitating condition that may be associated with symptoms such as bloating, early satiety, abdominal pain, and constipation. Management of chronic nausea can be challenging, and additional non-pharmacologic treatment options are needed. The EmeTerm device is a wearable transcutaneous electrical nerve stimulation (TENS) unit that stimulates the median nerve at the wrist. The stimulation is believed to influence signaling pathways involved in nausea and may reduce nausea sensations. The device has received FDA 510(k) clearance for the control of nausea and vomiting caused by motion sickness and pregnancy. [34_Emeterm...rotocol_v3 | Word] The WINNER (WearINg a TENS-device in Nausea Relief) Study is a single-center clinical trial conducted at The Ohio State University to evaluate the effectiveness of the EmeTerm wearable TENS device in adults with nausea that has persisted for more than 2 months. The primary objective is to determine whether use of the device reduces the frequency of moderate-to-severe nausea compared with a baseline observation period. Secondary objectives include evaluating changes in nausea duration, vomiting frequency, use of anti-nausea medications, gastrointestinal symptoms, appetite, sleep, fatigue, stress, mood, quality of life, autonomic symptoms, and hope. [34_Emeterm...rotocol_v3 | Word] Participants who meet eligibility criteria will first complete baseline assessments and record daily gastrointestinal symptoms during a 2-week baseline period. Participants who successfully complete the baseline phase will receive the EmeTerm device and enter a 12-week treatment period. During the treatment phase, participants will use the device as instructed while continuing to complete symptom diaries and study questionnaires. Outcomes will be assessed by comparing symptom measures collected during device use with those collected during the baseline period. Participant safety will be monitored through weekly adverse-event questionnaires and participant reporting of any side effects. [34_Emeterm...rotocol_v3 | Word] The study plans to have approximately 120 participants receive the device and complete the treatment phase.

Inclusion criteria

• Nausea present for more than 2 months. Age 18 years or older. Able to understand English. Receiving care at The Ohio State University. Able to complete online surveys using a smartphone or computer

Exclusion criteria

• Active treatment for cancer Current treatment for inflammatory bowel disease Cirrhosis End-stage renal disease Prior use of a wearable TENS unit for nausea Abdominal surgery within the previous 3 months Pregnancy (self-reported at enrollment) Current carpal tunnel syndrome Any contraindication to use of the EmeTerm device Inflammation, irritation, infection, ulceration, bleeding, open wounds, or other skin conditions near the wrist where the device is applied Presence of metallic implants in the body Head or facial injury within the previous 3 months Known brain tumor, meningitis, or stroke within the previous 3 months Cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device History of seizures