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

• Sponsor: Hospital General Universitario Elche (Other)
• Overall Status: Completed
• CT.gov ID: NCT01792947
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 8.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Appetite Reduction; Weight Loss	Procedure: Percutaneous electroneurostimulation of dermatome T6; Behavioral: Diet 1200 Kcal	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Percutaneous Electroneurostimulation of Dermatome T6 for Appetite Reduction and Weight Loss in Morbidly Obese Patients
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

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	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

Outcome Measures

Primary Outcome Measures

1. 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

1. Weight loss [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital general Universitario de Elche	Elche	Alicante	Spain	03202

Sponsors and Collaborators

• Hospital General Universitario Elche

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Professor, Hospital General Universitario Elche
• ClinicalTrials.gov Identifier: NCT01792947
• Other Study ID Numbers: HGUE2013-1
• First Posted: Feb 15, 2013
• Last Update Posted: Feb 15, 2013
• Last Verified: Feb 1, 2013

• Additional relevant MeSH terms: Body Weight; Weight Loss

Study Results

No Results Posted as of Feb 15, 2013