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

Primary Purpose

Appetite Reduction, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Percutaneous electroneurostimulation of dermatome T6
Diet 1200 Kcal
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appetite Reduction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital general Universitario de Elche

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Diet

PENS associated to diet

Arm Description

Diet 1200 Kcal during 3 months

Percutaneous electroneurostimulation of dermatome T6 associated to diet 1200 Kcal

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Weight loss

Full Information

First Posted
February 10, 2013
Last Updated
February 13, 2013
Sponsor
Hospital General Universitario Elche
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1. Study Identification

Unique Protocol Identification Number
NCT01792947
Brief Title
Percutaneous Electroneurostimulation of Dermatome T6 for Appetite Reduction and Weight Loss in Morbidly Obese Patients
Official Title
Percutaneous Electroneurostimulation of Dermatome T6 for Appetite Reduction and Weight Loss in Morbidly Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetite Reduction, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet
Arm Type
Active Comparator
Arm Description
Diet 1200 Kcal during 3 months
Arm Title
PENS associated to diet
Arm Type
Experimental
Arm Description
Percutaneous electroneurostimulation of dermatome T6 associated to diet 1200 Kcal
Intervention Type
Procedure
Intervention Name(s)
Percutaneous electroneurostimulation of dermatome T6
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Diet 1200 Kcal
Intervention Description
The patients assigned to this group must follow a 1200 Kcal diet during months
Primary Outcome Measure Information:
Title
Appetite reduction
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Weight loss
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Ruiz-Tovar, MD, PhD
Organizational Affiliation
General University Hospital Elche
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital general Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24122698
Citation
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.
Results Reference
derived

Learn more about this trial

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

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