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

Primary Purpose

Overweight, Obesity

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcutaneous Nerve Stimulator (TENS)

Diet & Exercise

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

St. Louis Women's Healthcare Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment

Control

Arm Description

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.

Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT03299881

First Posted

September 25, 2017

Last Updated

October 13, 2021

Sponsor

Elira Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03299881

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Terminated

Why Stopped

Early termination due to technical problems with the device.

Study Start Date

September 5, 2017 (Actual)

Primary Completion Date

April 1, 2018 (Actual)

Study Completion Date

April 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Elira Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized, adaptive parallel arm study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.

Intervention Type

Device

Intervention Name(s)

Transcutaneous Nerve Stimulator (TENS)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Diet & Exercise

Intervention Description

Subjects to be instructed on a healthy 1200 calorie diet.

Primary Outcome Measure Information:

Title

Treatment Emergent Adverse Events

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shelby Sullivan, MD

Organizational Affiliation

Consultant

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Louis Women's Healthcare Group

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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