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

Not Applicable

Completed

• Conditions: Appetite Reduction; Weight Loss
• Interventions: Behavioral: Diet 1200 Kcal; Procedure: Percutaneous electroneurostimulation of dermatome T6

• Registration Number: NCT01792947
• Lead Sponsor: Hospital General Universitario Elche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Study First Submitted: 2013-02-10
• Study First Submitted QC: 2013-02-13
• Last Update Submitted: 2013-02-13
• Study First Posted: 2013-02-15
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet	Diet 1200 Kcal	Diet 1200 Kcal during 3 months
PENS associated to diet	Percutaneous electroneurostimulation of dermatome T6	Percutaneous electroneurostimulation of dermatome T6 associated to diet 1200 Kcal
PENS associated to diet	Diet 1200 Kcal	Percutaneous electroneurostimulation of dermatome T6 associated to diet 1200 Kcal

Primary Outcome Measures

Name	Time	Method
Appetite reduction	3 months	The appetite reduction will be measured asking the patient to quantify the appetite sensation according to a visula analogic scale, ranged from 0 (absence of appetite) to 10 (incontrolable appetite). Appetite will be measured before the beginning of the treatment and after finishing it (after 12 weeks of treatment).

Secondary Outcome Measures

Name	Time	Method
Weight loss	3 months

Trial Locations

Locations (1)

Hospital general Universitario de Elche; 🇪🇸 Elche, Alicante, Spain