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Completed

NCT Number: NCT01792947

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.

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Key information

Conditions

Appetite Reduction Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital general Universitario de Elche

Elche, Alicante, 03202, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous electroneurostimulation of dermatome T6

Procedure

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

Diet 1200 Kcal

Behavioral

The patients assigned to this group must follow a 1200 Kcal diet during months

Primary outcomes

  1. Appetite reduction

    Time frame: 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 outcomes

  1. Weight loss

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 15, 2013
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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