Dermatome Electrical Stimulation on Individuals With Overweight and Class I Obesity

• Sponsor: Mayo Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03261531
• Collaborator: Elira Therapeutics, Inc. (Industry)
• Enrollment: 7
• Location: 1
• Arm: 1
• Actual Duration (Months): 23.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Investigators are doing this research study to find out the effect of T6 dermatomal electrical stimulation (delivered by a Transcutaneous Electrical Nerve Stimulation (TENS) unit) on appetite and weight loss.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Device: Transcutaneous electrical nerve stimulation (TENS)	N/A

Detailed Description

Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a Transcutaneous Electrical Nerve Stimulation (TENS) unit. Participants will receive 15-minute T6 dermatome cutaneous stimulation with TENS unit applied immediately before ingestion of two of main meals of the day (breakfast and evening meal), and 60 minute stimulation applied immediately after ingestion of these meals. Participants will apply the stimulus four times daily for a treatment period of at least 3 months. Participants will keep a diary of weight once weekly and a weekly appetite record.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effect of T6 Dermatome Electrical Stimulation on Gastric Motor Functions, Appetite, Satiation, Satiety and Weight Loss in Individuals With Overweight and Class I Obesity
• Actual Study Start Date: Feb 21, 2017
• Actual Primary Completion Date: Jan 30, 2019
• Actual Study Completion Date: Jan 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transcutaneous electrical nerve stimulation (TENS) Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)	Device: Transcutaneous electrical nerve stimulation (TENS); Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.

Outcome Measures

Primary Outcome Measures

1. Change in Body Weight [Baseline, 3 months]

   Change in body weight will be measured in kilograms or pounds

2. Gastric Half-emptying Time (GE T 1/2) [After 1 day treatment (approximately at 4 hours)]

   The time for half of the ingested solids to leave the stomach

3. Gastric Half-emptying Time (GE T 1/2) [At 3 months, approximately 2 hours after radiolabeled meal is ingested]

   The time for half of the ingested solids to leave the stomach

Secondary Outcome Measures

1. Fasting Gastric Volume by 99mTc-SPECT Imaging [At 3 months, approx 20 minutes after 99mTC injection]

   A noninvasive SPECT method will be used to measure gastric volume. Subjects will report to the clinic after an overnight fast. The first fasting scan will be obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.

2. Postprandial Gastric Volume (Gastric Accommodation) by 99mTc-SPECT Imaging [At 3 months, approximately 30 min after liquid meal]

   A noninvasive SPECT method will be used to measure gastric volume after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC will be given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.

3. Change in Gastric Emptying Percentage [Day 1, 3 months]

   The time for gastric retention of ingested solids or liquid to leave the stomach, measured in percentage.

4. Satiation Volume (Level 3) [Approximately 30 minutes after the liquid meal]

   Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal ("volume to fullness"), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5.

5. Satiation Maximum Tolerated Volume (Level 5) [Approximately 30 minutes after the liquid meal]

   Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal ("volume to fullness"), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5.

6. Mean Kcal Intake at Buffet Meal as a Measure of Appetite [At 3 months, approximately 30 minutes after the buffet meal]

   Assessment of kcal intake as a measure of appetite buffet meal to measure total caloric intake. 5 hours after ingesting 300 mL liquid nutrient as part of the gastric volume study, participants will be invited to eat, during a 30-minute period, a standard "free feeding" meal. The total amount of food consumed will be analyzed by the study dietitian.

7. Change in Appetite Score [Baseline, 3 months]

   Ratings of appetite will be measured every 30 minutes between the time of ingestion of standard liquid breakfast and the start of the ad libitum meal. The appetite rating will be measured by 4- 100 mm long Visual Analog Scales (VAS). The VAS does not have any pre-set marks between the extremes of 0 for negative rating and 100 mm for positive rating. The investigator measures the mark made by the participant in mm and records this for the value. The overall appetite score will be calculated as the average of the four individual scores (satiety + fullness+100-prospective food consumption + hunger/4.

8. Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months [baseline, 90 minutes postprandially]

   Total ghrelin will be measured by a radioimmunoassay technique.

9. Change in Fasting and Peak Postprandial Glucagon-like Peptide-1 (GLP-1) at 3 Months [baseline, 90 minutes postprandially]

   Glucagon-like peptide-1 (GLP-1) will be measured by a radioimmunoassay technique.

10. Change in Fasting and Peak Postprandial Peptide Tyrosine Tyrosine (PYY) at 3 Months [baseline, 90 minutes postprandially]

    Peptide Tyrosine Tyrosine (PYY) will be measured by radioimmunoassay.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Overweight and obese adults (BMI ≥25 kg/m2 and ≤34.99 kg/m2) residing within 125 miles of Mayo Clinic in Rochester, Minnesota; these will be otherwise healthy individuals with no unstable psychiatric disease and not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine (other than hyperglycemia on diet) disorders.

• Age: 18-65 years

• Gender: Men or women. Women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure.

• Subjects must have the ability to provide informed consent before any trial-related activities.

Eligible individuals will be asked to avoid taking additional medications and supplements for the duration of the study, unless reviewed and approved by the study team.

Exclusion Criteria:

• Abdominal surgery other than appendectomy, Caesarian section or tubal ligation

• Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., Orlistat

• Positive history of diabetes mellitus or use of hypoglycemic medications

• Positive history of spinal cord injury and/or chronic back pain

• Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD) (12), a self-administered alcoholism screening test (AUDIT-C) (13), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia) (14). If such a dysfunction is identified by a HAD score >11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.

• Intake of medication, whether prescribed or over the counter (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, thyroxine replacement therapy, low dose analgesia or anti-inflammatory medications (Acetaminophen and Ibuprofen) and any medication administered for co-morbidities as long as they do not alter gastrointestinal motility including gastric emptying and gastric accommodation.

• Subjects may also be excluded from participation for other factors at the discretion of the principal investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• Elira Therapeutics, Inc.

Investigators

• Principal Investigator: Michael Camilleri, M.D, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 18, 2017

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Michael Camilleri, MD, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03261531
• Other Study ID Numbers: 16-001916
• First Posted: Aug 25, 2017
• Last Update Posted: Feb 5, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Michael Camilleri, MD, Principal Investigator, Mayo Clinic: Overweight; Class I Obesity
• Additional relevant MeSH terms: Obesity; Overweight

Study Results

Participant Flow

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Period Title: Overall Study
STARTED	7
COMPLETED	3
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Overall Participants	7
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46 (12.2)
Sex: Female, Male (Count of Participants)
Female	3 42.9%
Male	4 57.1%
Race/Ethnicity, Customized (Count of Participants)
White	6 85.7%
Asian	1 14.3%
Region of Enrollment (participants) [Number]
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Change in Body Weight
Description	Change in body weight will be measured in kilograms or pounds
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Measure Participants	0

2. Primary Outcome

Title	Gastric Half-emptying Time (GE T 1/2)
Description	The time for half of the ingested solids to leave the stomach
Time Frame	After 1 day treatment (approximately at 4 hours)

Outcome Measure Data

Analysis Population Description

Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Measure Participants	0

3. Primary Outcome

Title	Gastric Half-emptying Time (GE T 1/2)
Description	The time for half of the ingested solids to leave the stomach
Time Frame	At 3 months, approximately 2 hours after radiolabeled meal is ingested

Outcome Measure Data

Analysis Population Description

Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Measure Participants	0

4. Secondary Outcome

Title	Fasting Gastric Volume by 99mTc-SPECT Imaging
Description	A noninvasive SPECT method will be used to measure gastric volume. Subjects will report to the clinic after an overnight fast. The first fasting scan will be obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.
Time Frame	At 3 months, approx 20 minutes after 99mTC injection

Outcome Measure Data

Analysis Population Description

Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Measure Participants	0

5. Secondary Outcome

Title	Postprandial Gastric Volume (Gastric Accommodation) by 99mTc-SPECT Imaging
Description	A noninvasive SPECT method will be used to measure gastric volume after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC will be given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.
Time Frame	At 3 months, approximately 30 min after liquid meal

Outcome Measure Data

Analysis Population Description

Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Measure Participants	0

6. Secondary Outcome

Title	Change in Gastric Emptying Percentage
Description	The time for gastric retention of ingested solids or liquid to leave the stomach, measured in percentage.
Time Frame	Day 1, 3 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Measure Participants	0

7. Secondary Outcome

Title	Satiation Volume (Level 3)
Description	Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal ("volume to fullness"), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5.
Time Frame	Approximately 30 minutes after the liquid meal

Outcome Measure Data

Analysis Population Description

Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Measure Participants	0

8. Secondary Outcome

Title	Satiation Maximum Tolerated Volume (Level 5)
Description	Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal ("volume to fullness"), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5.
Time Frame	Approximately 30 minutes after the liquid meal

Outcome Measure Data

Analysis Population Description

Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Measure Participants	0

9. Secondary Outcome

Title	Mean Kcal Intake at Buffet Meal as a Measure of Appetite
Description	Assessment of kcal intake as a measure of appetite buffet meal to measure total caloric intake. 5 hours after ingesting 300 mL liquid nutrient as part of the gastric volume study, participants will be invited to eat, during a 30-minute period, a standard "free feeding" meal. The total amount of food consumed will be analyzed by the study dietitian.
Time Frame	At 3 months, approximately 30 minutes after the buffet meal

Outcome Measure Data

Analysis Population Description

Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Measure Participants	0

10. Secondary Outcome

Title	Change in Appetite Score
Description	Ratings of appetite will be measured every 30 minutes between the time of ingestion of standard liquid breakfast and the start of the ad libitum meal. The appetite rating will be measured by 4- 100 mm long Visual Analog Scales (VAS). The VAS does not have any pre-set marks between the extremes of 0 for negative rating and 100 mm for positive rating. The investigator measures the mark made by the participant in mm and records this for the value. The overall appetite score will be calculated as the average of the four individual scores (satiety + fullness+100-prospective food consumption + hunger/4.
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Measure Participants	0

11. Secondary Outcome

Title	Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months
Description	Total ghrelin will be measured by a radioimmunoassay technique.
Time Frame	baseline, 90 minutes postprandially

Outcome Measure Data

Analysis Population Description

Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Measure Participants	0

12. Secondary Outcome

Title	Change in Fasting and Peak Postprandial Glucagon-like Peptide-1 (GLP-1) at 3 Months
Description	Glucagon-like peptide-1 (GLP-1) will be measured by a radioimmunoassay technique.
Time Frame	baseline, 90 minutes postprandially

Outcome Measure Data

Analysis Population Description

Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Measure Participants	0

13. Secondary Outcome

Title	Change in Fasting and Peak Postprandial Peptide Tyrosine Tyrosine (PYY) at 3 Months
Description	Peptide Tyrosine Tyrosine (PYY) will be measured by radioimmunoassay.
Time Frame	baseline, 90 minutes postprandially

Outcome Measure Data

Analysis Population Description

Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data

Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Measure Participants	0

Adverse Events

Time Frame	Adverse Events were collected up to 3 months for each subject
Arm/Group Title	Transcutaneous Electrical Nerve Stimulation (TENS)
Arm/Group Description	Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
All Cause Mortality
	Transcutaneous Electrical Nerve Stimulation (TENS)
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Serious Adverse Events
	Transcutaneous Electrical Nerve Stimulation (TENS)
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	Transcutaneous Electrical Nerve Stimulation (TENS)
	Affected / at Risk (%)	# Events
Total	0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.