Regional Cerebral Blood FlowNCT01095029
Cerebral Responses During Bilateral/Unilateral Sacral Nerve Stimulation for Idiopathic Faecal Incontinence
A study testing Medtronic InterStim II - 3058 in people with Regional Cerebral Blood Flow and Fecal Incontinence, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Cerebral Blood Flow, Fecal Incontinence
- What is being tested?
- Medtronic InterStim II - 3058
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2010to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
Aarhus, Aarhus C, 8000
About this study
Official title: 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.
Read the 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.
- Conditions
- Regional Cerebral Blood Flow, Fecal Incontinence
- Being tested
- Medtronic InterStim II - 3058
- Keywords
- Positron emission tomography (PET), Idiopathic Faecal Incontinence, Bilateral Sacral Nerve Stimulation, Sacral Nerve Stimulation, Sacral Nervemodulation
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic InterStim II - 3058Device
Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec.
| Study group | Role | What they receive |
|---|---|---|
| Off/Off | Experimental | Pacemaker status: Bilateral Off for four weeks before first PET scann. Receives: Device: Medtronic InterStim II - 3058 |
| On/On | Experimental | Pacemaker status: Bilateral On. PET scan one hour after activation and after four weeks continuous stimulation. Receives: Device: Medtronic InterStim II - 3058 |
| On/Off | Experimental | Pacemaker status: Unilateral On. PET scan one hour after activation and after four weeks continuous stimulation. Receives: Device: Medtronic InterStim II - 3058 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Regional Cerebral Blood Flow with different pacemaker settings
RCBF evaluated with positron emission tomography.
Measured: 12 weeks after study enrolment
Secondary outcomes (1)
Changes in continence and quality of life with different pacemaker activation.
Changes in incontinence episodes and quality of life will be correlated to changes in RCBF with different pacemaker activation.
Measured: 12 weeks after study enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2012
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Cerebral Blood FlowStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakob K Jakobsen, MD., Principal investigator, Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095029
- Sponsor's protocol ID
- 003
- Status last verified
- Mar 2012
- First submitted
- 22 Mar 2010
- Last updated
- 4 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Responses During Bilateral/Unilateral Sacral Nerve Stimulation for Idiopathic Faecal Incontinence - Assessed With Positron Emission Tomography Scan (PET-scan)
- ClinicalTrials.gov ID
- NCT01095029
- Acronym / sponsor ID
- 003
- Conditions
- Regional Cerebral Blood Flow, Fecal Incontinence
- Keywords
- Positron emission tomography (PET), Idiopathic Faecal Incontinence, Bilateral Sacral Nerve Stimulation, Sacral Nerve Stimulation, Sacral Nervemodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Off/Off | Experimental | Device: Medtronic InterStim II - 3058Pacemaker status: Bilateral Off for four weeks before first PET scann. |
| On/On | Experimental | Device: Medtronic InterStim II - 3058Pacemaker status: Bilateral On. PET scan one hour after activation and after four weeks continuous stimulation. |
| On/Off | Experimental | Device: Medtronic InterStim II - 3058Pacemaker status: Unilateral On. PET scan one hour after activation and after four weeks continuous stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic InterStim II - 3058Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec. | Device | Off/Off, On/Off, On/On |
Primary outcome
Changes in Regional Cerebral Blood Flow with different pacemaker settings
Time frame: 12 weeks after study enrolment
RCBF evaluated with positron emission tomography.
1 secondary outcome
Changes in continence and quality of life with different pacemaker activation.
Time frame: 12 weeks after study enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakob K Jakobsen, MD. principal investigator
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic InterStim II - 3058 in people with Regional Cerebral Blood Flow and Fecal Incontinence, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Regional Cerebral Blood Flow with different pacemaker settings (time frame: 12 weeks after study enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2014.