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

Official title

Evaluating the Effect of a WearIng a TENS-device in NausEa Relief (The WINNER Study)

Overview

The goal of this clinical trial is to learn whether a wearable transcutaneous electrical nerve stimulation (TENS) device called EmeTerm can help reduce nausea in adults who have had nausea for 2 months or longer and who receive care at The Ohio State University. The study will also evaluate whether use of the device affects other symptoms and aspects of wellbeing, including vomiting, abdominal pain, bloating, constipation, appetite, sleep, mood, stress, fatigue, quality of life, and hope. \[34\_Emeterm...rotocol\_v3 \| Word\] The main questions it aims to answer are: Does using the EmeTerm device reduce the average weekly frequency of moderate to severe nausea compared with symptoms during a baseline observation period? \[34\_Emeterm...rotocol\_v3 \| Word\] Does using the EmeTerm device reduce the duration of nausea, frequency of vomiting, and use of anti-nausea medications, and improve other gastrointestinal symptoms, wellbeing, and quality of life? \[34\_Emeterm...rotocol\_v3 \| Word\] This is a single-arm study. Participants will serve as their own comparison by comparing symptoms during device use with symptoms recorded during the baseline period before using the device. \[34\_Emeterm...rotocol\_v3 \| Word\] Participants will: Complete a screening survey and provide electronic informed consent if eligible. \[34\_Emeterm...rotocol\_v3 \| Word\] Complete baseline questionnaires and record daily gastrointestinal symptoms for a 2-week baseline period. \[34\_Emeterm...rotocol\_v3 \| Word\] Receive an EmeTerm wearable TENS device and instructions for its use. \[34\_Emeterm...rotocol\_v3 \| Word\] Use the EmeTerm device for 12 weeks while continuing to record nausea and other gastrointestinal symptoms. \[34\_Emeterm...rotocol\_v3 \| Word\] Complete weekly and monthly surveys about symptoms, stress, sleep, appetite, fatigue, quality of life, anxiety, depression, autonomic symptoms, device experience, and any adverse events.

Detailed description

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.

Interventions

• Device EmeTerm wearable TENS device
  EmeTerm wearable TENS device: A wrist-worn transcutaneous electrical nerve stimulation device that delivers low-frequency electrical stimulation to the median nerve to help control nausea and vomiting. Participants will use the device during a 12-week treatment period.

Primary outcome measures

• Change in Average Weekly Frequency of Moderate to Severe Nausea [Time frame: Baseline period (2 weeks) compared with the 12-week treatment period]

Secondary outcome measures (2)

• Change in Frequency of Vomiting [Time frame: Baseline period (2 weeks) compared with the 12-week treatment period.]
• Change in Use of Anti-Nausea Medications [Time frame: Baseline period (2 weeks) compared with the 12-week treatment period.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Ohio State University Wexner Medical Center — Columbus

Publications

• Sarosiek I, Song G, Sun Y, Sandoval H, Sands S, Chen J, McCallum RW. Central and Peripheral Effects of Transcutaneous Acupuncture Treatment for Nausea in Patients with Diabetic Gastroparesis. J Neurogastroenterol Motil. 2017 Apr 30;23(2):245-253. doi: 10.5056/jnm16097. PMID 28163260
• Rosen T, de Veciana M, Miller HS, Stewart L, Rebarber A, Slotnick RN. A randomized controlled trial of nerve stimulation for relief of nausea and vomiting in pregnancy. Obstet Gynecol. 2003 Jul;102(1):129-35. doi: 10.1016/s0029-7844(03)00375-2. PMID 12850618
• Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18. PMID 28826627
• Maharjan A, Peng M, Cakmak YO. The effects of frequency-specific, non-invasive, median nerve stimulation on food-related attention and appetite. Appetite. 2022 Feb 1;169:105807. doi: 10.1016/j.appet.2021.105807. Epub 2021 Nov 17. PMID 34798222
• Pearl ML, Fischer M, McCauley DL, Valea FA, Chalas E. Transcutaneous electrical nerve stimulation as an adjunct for controlling chemotherapy-induced nausea and vomiting in gynecologic oncology patients. Cancer Nurs. 1999 Aug;22(4):307-11. doi: 10.1097/00002820-199908000-00008. PMID 10452208

Identifiers

NCT: NCT07720323 · 2022H0384

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗