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

• Conditions: Obesity
• Interventions: Other: Enabling and disabling VNS

• Registration Number: NCT01491282
• Lead Sponsor: Maastricht University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-30
• Study Start: 2011-01
• Status Verified: 2011-12
• Study First Submitted QC: 2011-12-11
• Last Update Submitted: 2011-12-11
• Study First Posted: 2011-12-13
• Last Update Posted: 2011-12-13
• Primary Completion: 2012-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No treatment	Enabling and disabling VNS	-

Primary Outcome Measures

Name	Time	Method
human brown adipose tissue activity	baseline and 2 weeks after

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Netherlands