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

Sponsor
Maastricht University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01491282
Collaborator
(none)
5
Enrollment
1
Location
22
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Enabling and disabling VNS

Study Design

Study Type:
Observational
Anticipated Enrollment :
5 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Brown Adipose Tissue After Vagus Nerve Stimulation
Study Start Date :
Jan 1, 2011
Anticipated Primary Completion Date :
Nov 1, 2012
Anticipated Study Completion Date :
Nov 1, 2012

Arms and Interventions

Arm Intervention/Treatment
No treatment

Other: Enabling and disabling VNS
No intervention
Other Names:
  • VNS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. human brown adipose tissue activity [baseline and 2 weeks after]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maastricht University Maastricht Netherlands 6200MD

    Sponsors and Collaborators

    • Maastricht University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    dr. Sef Janssen, Dr. W.D. van Marken Lichtenbelt, Maastricht University
    ClinicalTrials.gov Identifier:
    NCT01491282
    Other Study ID Numbers:
    • MEC 10-3-071
    First Posted:
    Dec 13, 2011
    Last Update Posted:
    Dec 13, 2011
    Last Verified:
    Dec 1, 2011
    Keywords provided by dr. Sef Janssen, Dr. W.D. van Marken Lichtenbelt, Maastricht University
    human brown adipose tissue activity
    obesity
    energy metabolism
    adaptive thermogenesis
    Additional relevant MeSH terms:
    Obesity

    Study Results

    No Results Posted as of Dec 13, 2011