Percutaneous Electroneurostimulation of Dermatome T6 for Appetite Reduction and Weight Loss in Morbidly Obese Patients

Hospital General Universitario Elche

Status: Completed

Conditions: Appetite Reduction; Weight Loss

Treatments: Procedure: Percutaneous electroneurostimulation of dermatome T6; Behavioral: Diet 1200 Kcal

Study type: Interventional

Funder types: Other

Identifiers

NCT01792947

HGUE2013-1

Details and patient eligibility

About

Based on the creation of a somato-autonomic reflex, the stimulation of sensory nerve terminals located in dermatome T6 may cause a reflex, whose efferent pathways end in vagal nerve branches stimulating the gastric wall, similarly to the gastric pacemaker.

The aim of this study was to evaluate the effect of percutaneous electroneurostimulation (PENS) of T6 dermatome on appetite, weight loss and dietary compliance.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients candidates to bariatric surgery
• BMI > 40 Kg/m2 or a BMI > 35 Kg/m2 with comorbidities associated to the obesity status
• Failure of dietary treatment.

Exclusion criteria

• untreated endocrine disease causing obesity
• serious psychiatric illness.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Diet

Active Comparator group

Description:

Diet 1200 Kcal during 3 months

Treatment:

Behavioral: Diet 1200 Kcal

PENS associated to diet

Experimental group

Description:

Percutaneous electroneurostimulation of dermatome T6 associated to diet 1200 Kcal

Treatment:

Procedure: Percutaneous electroneurostimulation of dermatome T6

Behavioral: Diet 1200 Kcal