Study of the Effect of Vagus Nerve Stimulation on Human Brown Adipose Tissue Activity

December 11, 2011 updated by: dr. Sef Janssen, Maastricht University

Brown Adipose Tissue After Vagus Nerve Stimulation

To evaluate the effect of vagus nerve stimulation for refractory epilepsy on the activity of human brown adipose tissue.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6200MD
        • Recruiting
        • Maastricht University
        • Contact:
        • Principal Investigator:
          • Wouter D. van Marken Lichtenbelt, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Postoperative patients treated with vagus nerve stimulation for refractory epilepsy

Description

Inclusion Criteria:

  • Subjects treated with VNS for epilepsy, aged 18-65 years, with a Body Mass Index (BMI) ≤ 28 kg/m2.

Exclusion Criteria:

  • Body Mass Index > 28 kg/m2
  • Daily epileptic insults.
  • Subjects that need 'Rapid Cycling' VNS to control their frequency of epileptic insults.
  • Psychological unstable subjects (as judged by the treating neurologist).
  • subjects with mental retardation (as judged by the treating neurologist).
  • subjects with severe behaviour disorders (as judged by the treating neurologist).
  • Pregnant subjects.
  • Subjects that previously underwent high dose radiation for diagnostic or therapeutic purposes (radiotherapy, high frequency CT-scans).

  • The use of the following medication is an exclusion criterium;

    • ß-blockers,
    • Ketogenic diet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No treatment
Other: Enabling and disabling VNS
No intervention
Other Names:
  • VNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
human brown adipose tissue activity
Time Frame: baseline and 2 weeks after
baseline and 2 weeks after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University

Investigators

  • Principal Investigator: Wouter D. van Marken Lichtenbelt, PhD., Department of Human Biology, Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

November 30, 2010

First Submitted That Met QC Criteria

December 11, 2011

First Posted (Estimate)

December 13, 2011

Study Record Updates

Last Update Posted (Estimate)

December 13, 2011

Last Update Submitted That Met QC Criteria

December 11, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 10-3-071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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