NCT01491282

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
12 months until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

1.8 years

First QC Date

November 30, 2010

Last Update Submit

December 11, 2011

Conditions

Obesity

Keywords

human brown adipose tissue activityobesityenergy metabolismadaptive thermogenesis

Outcome Measures

Primary Outcomes (1)

  • human brown adipose tissue activity

    baseline and 2 weeks after

Study Arms (1)

No treatment

Other: Enabling and disabling VNS

Interventions

Enabling and disabling VNSOTHER

No intervention

Also known as: VNS
No treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postoperative patients treated with vagus nerve stimulation for refractory epilepsy

You may qualify if:

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

You may not qualify if:

  • 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).
  • ß-blockers,
  • Ketogenic diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, 6200MD, Netherlands

RECRUITING

Related Publications (1)

  • Vijgen GH, Bouvy ND, Leenen L, Rijkers K, Cornips E, Majoie M, Brans B, van Marken Lichtenbelt WD. Vagus nerve stimulation increases energy expenditure: relation to brown adipose tissue activity. PLoS One. 2013 Oct 23;8(10):e77221. doi: 10.1371/journal.pone.0077221. eCollection 2013.

    PMID: 24194874DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wouter D. van Marken Lichtenbelt, PhD.

    Department of Human Biology, Maastricht University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy H. Vijgen, M.D.

CONTACT

+31618942736G.vijgen@maastrichtuniversity.nl

Wouter D. van Marken Lichtenbelt, PhD.

CONTACT

+31433881629markenlichtenbelt@maastrichtuniversity.nl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. W.D. van Marken Lichtenbelt

Study Record Dates

First Submitted

November 30, 2010

First Posted

December 13, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 13, 2011

Record last verified: 2011-12

Locations

NL(1)