Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss

Study Overview
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Brief Summary
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This study is a randomized, adaptive, parallel arm study. The treatment group will receive the Elira wearable patch system and provided instructions for use and advised to follow a 1200 calorie diet. The control group will be asked to follow a 12 calorie diet only. Each group will be followed for 12 weeks. Total body weight loss will be measured as well as appetite changes. Safety data will be collected throughout the study period. Safety and effectiveness will be determined based on differences between the groups.

Detailed Description
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This study employs a randomized, adaptive, parallel arm study in which, cohorts of enrolled subjects (25 per arm) are assessed for dose response and progression to achievement of primary and secondary endpoints. Enrollment will be up to 300 subjects at 4 US centers. After signing informed consent, subjects will be screened during a one week screening/baseline period to determine if they meet the inclusion criteria and exhibit none of the exclusion criteria. Weight, blood pressure, blood lipids, HgA1c, pregnancy test (for women of childbearing age), and patient questionnaires will be collected. If eligible, subjects will be randomized to treatment or control groups. The treatment group will receive training on the Elira Wearable Patch System and the first TENS session will be administered in the investigators office. Both groups will receive an electronic scale and instructions on 1200 calorie diet as well as diary completion requirements to be completed throughout the study. All subjects will be required to have in office follow-up visits every 4 weeks for 12 weeks. Up to 2 additional follow-up visits will be permitted within that 12 week time period.

Official Title
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Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Device: Transcutaneous Nerve Stimulator (TENS)
* Behavioral: Diet & Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is between 18 - 65 years of age inclusive. Subject has a BMI of 25-35 kg/ m^2 inclusive. Subject has signed the informed consent form and is able to comply with study protocol and adhere to study visit schedule. Subject is able to wear and use a wearable, patch TENS system. Subject is able to use a touch screen hand held smart phone. Subject is fluent in English and can complete patient questionnaires. Subject can comply with a 1200 calorie the recommended diet for the duration of the study. Subject is male or non-pregnant, non-lactating female, who agrees to use effective contraceptive methods throughout the length of the trial based on PI approval. Females of childbearing potential must have a negative urine pregnancy test at enrollment visit, prior to placement of ELIRA device. Exclusion Criteria Subject has any known gastrointestinal disorder that in the opinion of the PI precludes enrollment into the trial. Subject has had a prior bariatric procedure. Subject has any significant multisystem disease in the opinion of the PI. Subject has > 6.5 HbA1c. Subject has significant cardiac arrhythmia, ectopy, or significant cardiovascular disease. Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD). Subject is a female of child-bearing potential who is pregnant or intends to become pregnant during the trial. Subject has a history of any malignancy in the last 2 years. Subject has had a weight change of + 5% of his/her Total Body Weight in the 3 months prior to enrollment. Subject has a moderate / severe psychiatric disorder. Subject has a diagnosed neurological disease. Subject has a diagnosed eating disorder. Subject has a skin disorder affecting the thoracic dermatomes. Subject has abdominal surgery or other scars which may interfere with stimulation in the opinion of the PI. Subject is currently enrolled in other, potentially confounding research. Subject has known allergic reaction to materials in the electrodes and/or is otherwise unable to tolerate stimulation with the wearable TENS system. Subject is actively participating or unwilling to discontinue participation in another weight loss program. Subject is taking weight loss control medications including but not limited to OTC medications, Metformin, and Belviq. Subject is unable to take anti-nausea medications planned for the study. Inability to walk at least 0.8 kilometers per day (10 minutes of continuous walking). Current smoker or user of nicotine product or smoking cessation within 1 year of the screening date. History of treatment for or current abuse of drugs or alcohol. A score of ≥10 on the Patient Health Questionnaire 9 (PHQ-9), demonstrating moderate depression. Any subject that the investigator considers inappropriate for the study for medical reasons. Subject has a history of migraine and/or is taking Topiramate for severe headache disorders. Subject is on hormonal or other drug therapy which may alter antral motility or appetite, per physician discretion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, adaptive parallel arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite. | Device: Transcutaneous Nerve Stimulator (TENS)<br>* The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.<br>Behavioral: Diet & Exercise<br>* Subjects to be instructed on a healthy 1200 calorie diet.<br>|
| Active Comparator: Control<br>Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite. | Behavioral: Diet & Exercise<br>* Subjects to be instructed on a healthy 1200 calorie diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Emergent Adverse Events | Safety/Tolerability will be assessed by the non-inferiority of incidence of serious adverse events (SAEs), unanticipated DAEs (USAEs), device-related SAEs (DSAEs), and unanticipated device-related SAEs (UDAEs) that are associated with the TENS therapy throughout the stimulation and the follow-up period versus historical control (compared with other TENS systems). | 12 weeks |