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

M

Maastricht University

Status

Unknown

Conditions

Obesity

Treatments

Other: Enabling and disabling VNS

Study type

Observational

Funder types

Other

Identifiers

NCT01491282
MEC 10-3-071

Details and patient eligibility

About

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

Enrollment

5 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

5 participants in 1 patient group

No treatment
Treatment:
Other: Enabling and disabling VNS

Trial contacts and locations

1

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Central trial contact

Guy H. Vijgen, M.D.; Wouter D. van Marken Lichtenbelt, PhD.

Data sourced from clinicaltrials.gov

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