# Wearable Transcutaneous Electrical Acustimulation for Gastroparesis

> **NIH NIH R44** · TRANSTIMULATION RESEARCH, INC. · 2021 · $59,616

## Abstract

Gastroparesis is a common disease defined as delayed gastric emptying with associated
symptoms in the absence of mechanical obstructions. It is reported in about 25-30% of patients
with functional dyspepsia and affects about 10-20% of general population, including 40%
prevalence in type 1 diabetes. Gastroparesis is a refractory disease with a lack of therapeutic
options. Common symptoms of gastroparesis include early satiety, postprandial fullness,
nausea, vomiting, bloating and upper abdominal pain.
 Electroacupuncture (EA) or acupuncture has been proposed to treat functional
gastrointestinal disorders in both basic and clinical researches. Transcutaneous electric
acustimulation (TEA) is a modification of EA with the advantages of non-invasiveness, home-
based operation, daily administration and low cost; it allows the patients to maintain the daily
treatment without affecting his/her daily activity. In a previous preclinical study, the prototype
TEA device developed by the company was shown to improve symptoms in patients with
diabetic gastroparesis.
 In the current proposal, a wearable and wireless TEA device will be designed and developed
based on the previous prototype device. A disposable adhesive electrode pad (5.5cm x 2.4cm x
0.2cm) and a snapped-on micro-stimulator weighing less than 10g will be developed during the
first year of the project. The device will be controlled wirelessly via a smartphone with APP
installed to track-record of therapeutic compliance. To investigate the effects of the TEA device
on symptoms and major pathophysiologies of gastroparesis, a randomized, sham-controlled
clinical study will be performed during the second year of the project in 30 patients with diabetic
gastroparesis divided in to two treatment groups: TEA and sham-TEA. Each treatment will last 8
weeks in parallel followed by 4-week either sham-TEA (for the TEA group) or TEA (for the
sham-TEA group). The primary outcomes will be gastroparesis symptoms; the secondary
outcomes will include gastric emptying, the quality of life symptoms and all major
pathophysiologies of gastroparesis and autonomic mechanisms.
 A comprehensive team has been assembled, including experts in neuromodulation,
gastrointestinal motility, gastroparesis, and device development.

## Key facts

- **NIH application ID:** 10458993
- **Project number:** 3R44AT011380-01A1S1
- **Recipient organization:** TRANSTIMULATION RESEARCH, INC.
- **Principal Investigator:** Jieyun None Yin
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $59,616
- **Award type:** 3
- **Project period:** 2020-09-21 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10458993

## Citation

> US National Institutes of Health, RePORTER application 10458993, Wearable Transcutaneous Electrical Acustimulation for Gastroparesis (3R44AT011380-01A1S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10458993. Licensed CC0.

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