Percutaneous Electroneurostimulation of Dermatome T6 for Appetite Reduction and Weight Loss in Morbidly Obese Patients
- Conditions
- Appetite ReductionWeight Loss
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- untreated endocrine disease causing obesity
- serious psychiatric illness.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Hospital general Universitario de Elche🇪🇸Elche, Alicante, Spain