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

July 3, 2014 updated by: University of Aarhus

Cerebral Responses During Bilateral/Unilateral Sacral Nerve Stimulation for Idiopathic Faecal Incontinence - Assessed With Positron Emission Tomography Scan (PET-scan)

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.

Study Overview

Detailed Description

Faecal incontinence is a devastating condition affecting daily living and quality of life. A new treatment Sacral Nerve Stimulation (SNS) has over the last decade given new hope to these patients. In Europe SNS is routinely offered to patients not archiving satisfactory continence result with standard non-surgical treatments. SNS is electrical stimulation of the sacral nerve root(s2,3 or 4). Stimulation of this nerve roots results in improved continence. The mechanism of action is at present not well described. Recent studies have shown that the effect of SNS is by means a neuromodulation in the central nervous system, whereas direct stimulation of efferent nerves to the anal sphincter and the pelvic floor has less significance.

The aim of this study is to describe changes in regional cerebral blood flow (RCBF), with positron emission tomography (PET), in patients implanted bilaterally with sacral neuromodulators with the indication idiopathic faecal incontinence.

RCBF in three deferent stimulations settings will be compared. PET will be performed before and one hour after changes in the activity status of the pacemakers. Four weeks prior to the first scan, patients are informed to switch both neurostimulator off. PET will be performed with the pacemaker settings: OFF/OFF (Stimulation status of left/right pacemaker), On/Off and On/On. The order of the On/OFF and On/On period will be random. Unilateral stimulation will be performed with the pacemaker there has the best efficacy, determined prior to study enrolment. The interval between these three pacemaker settings is four weeks. Four weeks prior to each PET scan the patients fill in bowel habit diaries, bowel habit questionnaires and quality of life assessments.

The association between continence and changes in RCBF will be studied. Additional RCBF and quality of life will be compared.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Aarhus C
      • Aarhus, Aarhus C, Denmark, 8000
        • Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Informed consent
  • Idiopathic fecal incontinence or Fecal incontinence due to small sphincter defect(≤60 o)
  • Permanent neuromodulator (medtronic InterStim II) bilateral implanted
  • Reduction in fecal incontinence episodes of at least 50% between baseline and latest follow up with unilateral stimulation(Bowel diary card)
  • Willing and competent to fill out diary cards
  • MR-cerebrum before implantatation of neuromodulator
  • Right-handed dominant

Exclusion Criteria:

  • Colorectal/proctological surgery since IPG-implant
  • Pregnancy
  • Neurological diseases including spinal cord injury.
  • Use of medication with known alternation of gastrointestinal motilitet (thyroid, diabetes, neuroleptica)
  • Claustrofobia
  • Latex allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Off/Off
Pacemaker status: Bilateral Off for four weeks before first PET scann.
Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec.
EXPERIMENTAL: On/On
Pacemaker status: Bilateral On. PET scan one hour after activation and after four weeks continuous stimulation.
Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec.
EXPERIMENTAL: On/Off
Pacemaker status: Unilateral On. PET scan one hour after activation and after four weeks continuous stimulation.
Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Regional Cerebral Blood Flow with different pacemaker settings
Time Frame: 12 weeks after study enrolment
RCBF evaluated with positron emission tomography.
12 weeks after study enrolment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in continence and quality of life with different pacemaker activation.
Time Frame: 12 weeks after study enrolment
Changes in incontinence episodes and quality of life will be correlated to changes in RCBF with different pacemaker activation.
12 weeks after study enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

March 22, 2010

First Submitted That Met QC Criteria

March 26, 2010

First Posted (ESTIMATE)

March 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 4, 2014

Last Update Submitted That Met QC Criteria

July 3, 2014

Last Verified

March 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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