Recruiting

EmeTerm

Sponsor:

Ohio State University

Code:

NCT07720323

Conditions

Chronic Nausea

Chronic Nausea and Vomiting Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EmeTerm wearable TENS device

Study Details

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

Study ID

NCT07720323

Start date

Feb 1, 2023

Status verified date

Jul, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: EmeTerm Wearable TENS Device

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.

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

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

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

Locations

Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Subhankar Chakraborty, MD, Ph.D.

614-293-6255'subhankar.chakraborty@osumc.edu

Subhankar Chakraborty, MD, Ph.D.

614-293-6255'subhankar2505206@yahoo.com

More Information

Sponsor

Ohio State University

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-07-22.