PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure

Percutaneous Electrical Neurostimulation (PENS) of Dermatome T6 With an Ambulatory Self-applied Patch vs PENS of Dermatome T6 With Conventional Procedure: Effect on Appetite and Weight Loss in Moderately Obese Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02564627

Enrollment

Registered

2015-10-01

Start date

2015-07-31

Completion date

2015-09-30

Last updated

2015-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Loss

Brief summary

A prospective randomized study, including moderately obese patients will be included. Patients will be randomized in 3 groups: * PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet * PENS of dermatome T6 with conventional procedure + 1200Kcal/day diet * Only 1200Kcal/day diet The effect on appetite and weight loss will be investigated.

Detailed description

A prospective randomized study, including moderately obese (BMI 30-39 Kg/m2) patients will be included. Patients will be randomized in 3 groups: * PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet * PENS of dermatome T6 with conventional procedure (weekly stimulation in the Outpatient Clinic) + 1200Kcal/day diet * Only 1200Kcal/day diet The effect on appetite and weight loss will be investigated.

Interventions

PROCEDURESelf-applied patch

An ambulatory self-applied patch will be placed weekly by the patients for PENS of dermatome T6.

PROCEDUREConventional procedure

PENS of dermatome T6 will be applied by the MD in the Outpatient Clinic.

DIETARY_SUPPLEMENT1200 Kcal/day diet

A 1200 Kcal/day diet will be prescribed.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Moderately obese patients (BMI 30-39 kg/m2)

Exclusion criteria

* Endocrinological diseases causing obesity * Heart pacemaker * Previous bariatric procedure

Design outcomes

Primary

Measure	Time frame	Description
Appetite will be quantified with a visual analogic scale	12 weeks	Appetite will be quantified weekly during the 12 weeks of treatment. Appetite will be quantified with a visual analogic scale (0= absence of appetite, 10=uncontrollable appetite)

Secondary

Measure	Time frame	Description
Weight loss	12 weeks	Appetite will be quantified weekly during the 12 weeks of treatment
Compliance will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist	12 weeks	The compliance with the 3 arms of treatment will be investigated. Diet complience will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026