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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Appetite Reduction
• Intervention / Treatment: Behavioral: Diet 1200 Kcal; Procedure: Percutaneous electroneurostimulation of dermatome T6

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03202
      • Hospital General Universitario de Elche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diet; Diet 1200 Kcal during 3 months	Behavioral: Diet 1200 Kcal; The patients assigned to this group must follow a 1200 Kcal diet during months
Experimental: PENS associated to diet; Percutaneous electroneurostimulation of dermatome T6 associated to diet 1200 Kcal	Behavioral: Diet 1200 Kcal; The patients assigned to this group must follow a 1200 Kcal diet during months; Procedure: Percutaneous electroneurostimulation of dermatome T6; The patients underwent a percutaneous electroneurostimulation of dermatome T6 during 30 minutes, every week during 12 weeks. This intervention was associated to a diet 1200 Kcal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appetite reduction	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).	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Weight loss	3 months

Collaborators and Investigators

• Sponsor: Hospital General Universitario Elche
• Investigators: Principal Investigator: Jaime Ruiz-Tovar, MD, PhD, General University Hospital Elche

Publications and helpful links

General Publications

• Ruiz-Tovar J, Oller I, Diez M, Zubiaga L, Arroyo A, Calpena R. Percutaneous electrical neurostimulation of dermatome T6 for appetite reduction and weight loss in morbidly obese patients. Obes Surg. 2014 Feb;24(2):205-11. doi: 10.1007/s11695-013-1091-z.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: February 10, 2013
• First Submitted That Met QC Criteria: February 13, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 13, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: HGUE2013-1