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

NCT07720323 | Recruiting FDA Device

• 1 other identifier: 2022H0384
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Nausea; Chronic Nausea and Vomiting Syndrome

Keywords

chronic nausea; TENS; wearable device; median nerve stimulation; nausea and vomiting; gastroparesis; neuromodulation; quality of life; vomiting; appetite

Outcome Measures

Primary Outcomes (1)

• Change in Average Weekly Frequency of Moderate to Severe Nausea

  Participants will complete a daily nausea diary during the baseline period and during the 12-week treatment period. Each day, participants will report whether they experienced nausea and rate its severity as no nausea, mild nausea, moderate nausea (required medication to control symptoms), or severe nausea (not responding to current medications). The outcome will be calculated as the average weekly frequency of days with moderate or severe nausea during the treatment period compared with the baseline period.

  Baseline period (2 weeks) compared with the 12-week treatment period

Secondary Outcomes (2)

• Change in Frequency of Vomiting

  Baseline period (2 weeks) compared with the 12-week treatment period.

• Change in Use of Anti-Nausea Medications

  Baseline period (2 weeks) compared with the 12-week treatment period.

Study Arms (1)

EmeTerm Wearable TENS Device

EXPERIMENTAL

Participants in this single-arm study will complete a 2-week baseline period during which they record daily gastrointestinal symptoms, including nausea. Participants who complete the baseline phase will receive the EmeTerm wearable transcutaneous electrical nerve stimulation (TENS) device and instructions for its use. During the 12-week treatment period, participants will use the device to help manage nausea while continuing to complete daily symptom diaries and weekly and monthly questionnaires. Study outcomes will compare symptom severity and other patient-reported measures during device use with those recorded during the baseline period.

Device: EmeTerm wearable TENS device

Interventions

EmeTerm wearable TENS device 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.

EmeTerm Wearable TENS Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Nausea; Vomiting; Gastroparesis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations

Study Officials

• Subhankar CHAKRABORTY, MD, Ph.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SUBHANKAR CHAKRABORTY, M.D., Ph.D.

CONTACT

614-293-6255'; Subhankar.chakraborty@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-group assignment study in which all eligible participants receive the EmeTerm wearable transcutaneous electrical nerve stimulation (TENS) device. Participants first complete a 2-week baseline observation period with daily symptom recording, followed by a 12-week treatment period using the device. Outcomes are evaluated by comparing symptoms and patient-reported measures collected during device use with those collected during the baseline period.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)