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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792947
• Other study ID #: HGUE2013-1
• Status: Completed
• Phase: N/A
• First received: February 10, 2013
• Last updated: February 13, 2013
• Start date: June 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appetite Reduction
• Weight Loss

Intervention

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

Behavioral:
• Diet 1200 Kcal
The patients assigned to this group must follow a 1200 Kcal diet during months

Locations

Country	Name	City	State
Spain	Hospital general Universitario de Elche	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Weight loss		3 months	Yes