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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Maastricht University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
dr. Sef Janssen, Maastricht University
ClinicalTrials.gov Identifier:
NCT01491282
First received: November 30, 2010
Last updated: December 11, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention
Obesity
Other: Enabling and disabling VNS

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Brown Adipose Tissue After Vagus Nerve Stimulation

Resource links provided by NLM:


Further study details as provided by Maastricht University:

Primary Outcome Measures:
  • human brown adipose tissue activity [ Time Frame: baseline and 2 weeks after ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: January 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No treatment Other: Enabling and disabling VNS
No intervention
Other Name: VNS

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Postoperative patients treated with vagus nerve stimulation for refractory epilepsy

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491282

Contacts
Contact: Guy H. Vijgen, M.D. +31618942736 G.vijgen@maastrichtuniversity.nl
Contact: Wouter D. van Marken Lichtenbelt, PhD. +31433881629 markenlichtenbelt@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Recruiting
Maastricht, Netherlands, 6200MD
Contact: Guy H.E.J. Vijgen, M.D.    0433884252    g.vijgen@maastrichtuniversity.nl   
Principal Investigator: Wouter D. van Marken Lichtenbelt, PhD         
Sponsors and Collaborators
Maastricht University
Investigators
Principal Investigator: Wouter D. van Marken Lichtenbelt, PhD. Department of Human Biology, Maastricht University
  More Information

No publications provided by Maastricht University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: dr. Sef Janssen, Dr. W.D. van Marken Lichtenbelt, Maastricht University
ClinicalTrials.gov Identifier: NCT01491282     History of Changes
Other Study ID Numbers: MEC 10-3-071
Study First Received: November 30, 2010
Last Updated: December 11, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University:
human brown adipose tissue activity
obesity
energy metabolism
adaptive thermogenesis

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014