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Cerebral Responses During Bilateral/Unilateral Sacral Nerve Stimulation for Idiopathic Faecal Incontinence

NCT01095029 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-07-04

No results posted yet for this study

Summary

The purpose of this study is to determine whether Sacral Nerve Stimulation (SNS) for idiopathic faecal incontinence affect cortical and deep brain activity in an acute and chronically stimulation model. Furthermore the association between brain activity and unilateral/bilateral SNS will be studied in each patient. Brain activity will be studied by use of positron emission tomography.

Conditions

  • Regional Cerebral Blood Flow
  • Fecal Incontinence

Interventions

DEVICE

Medtronic InterStim II - 3058

Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Jakob K Jakobsen, MD. · Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-08-31
Completion
2014-07-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01095029 on ClinicalTrials.gov