Parkinson's DiseaseSCP-ComodigNCT01081457
Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility
A study testing Deep brain stimulation in people with Parkinson's Disease, run by University Hospital, Rouen at 1 site in France.
Trial summary
Parkinson's disease is characterized by extra-pyramidal symptoms as well as digestive involvement with gastrointestinal motility (GI) impairment. Deep brain stimulation has been recently developed as a successful treatment for extrapyramidal symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Jan 2012
- 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
- patient over 18 yo
- patient with Parkinson's disease implanted for deep brain stimulation
- patient responders to deep brain stimulation (UPDRS improved by at least 40%)
- patient covered by the french health care system
- patient not taking anti-parkinsonian medication the day before evaluation
- French speaking
Who cannot join
- patient below 18 yo
- pregnancy
- Severe psychiatric or cognitive disorders
- diabetes mellitus
- morbid obesity
- compulsive eating disorders
Show all 10Show fewer
- diffuse GI motility impairment (except Parkinson's disease)
- other evolutive neurologic disorders
- previous history of significant GI resection
- inability to swallow or defecate when asked
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Deep Brain Stimulation on Voluntary and Involuntary Gastrointestinal Motility in Parkinson's Disease
Parkinson's disease is characterized by extra-pyramidal symptoms as well as digestive involvement with gastrointestinal motility (GI) impairment. Deep brain stimulation has been recently developed as a successful treatment for extrapyramidal symptoms. In addition, preliminary reports suggest that this therapy might be successful to relieve GI symptoms as well. The aim of this study is therefore to assess the effect of deep brain stimulation on GI voluntary as well as involuntary motility.
- Conditions
- Parkinson's Disease
- Being tested
- Deep brain stimulation
- Keywords
- Parkinson's disease, deep brain stimulation, GI motility
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
Comparison ON vs OFF
| Study group | Role | What they receive |
|---|---|---|
| ON | Active comparator | Stimulator switched ON Receives: Device: Deep brain stimulation |
| OFF | Sham comparator | Stimulator switched OFF Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anal pressure
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume GOURCEROL, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081457
- Sponsor's protocol ID
- 2008/163/HP
- Acronym
- SCP-Comodig
- Status last verified
- Feb 2012
- First submitted
- 4 Mar 2010
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Derrey S, Chastan N, Maltete D, Verin E, Dechelotte P, Lefaucheur R, Proust F, Freger P, Leroi AM, Weber J, Gourcerol G. Impact of deep brain stimulation on pharyngo-esophageal motility: a randomized cross-over study. Neurogastroenterol Motil. 2015 Sep;27(9):1214-22. doi: 10.1111/nmo.12607. Epub 2015 Jun 5.
PubMed 26053217
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Brain Stimulation on Voluntary and Involuntary Gastrointestinal Motility in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01081457
- Acronym / sponsor ID
- SCP-Comodig / 2008/163/HP
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, deep brain stimulation, GI motility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 5 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.
Parkinson's disease is characterized by extra-pyramidal symptoms as well as digestive involvement with gastrointestinal motility (GI) impairment. Deep brain stimulation has been recently developed as a successful treatment for extrapyramidal symptoms. In addition, preliminary reports suggest that this therapy might be successful to relieve GI symptoms as well. The aim of this study is therefore to assess the effect of deep brain stimulation on GI voluntary as well as involuntary motility.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ON | Active comparator | Device: Deep brain stimulationStimulator switched ON |
| OFF | Sham comparator | Device: Deep brain stimulationStimulator switched OFF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patient over 18 yo
- patient with Parkinson's disease implanted for deep brain stimulation
- patient responders to deep brain stimulation (UPDRS improved by at least 40%)
- patient covered by the french health care system
- patient not taking anti-parkinsonian medication the day before evaluation
Key exclusion criteria (10 listed)
- patient below 18 yo
- pregnancy
- Severe psychiatric or cognitive disorders
- diabetes mellitus
- morbid obesity
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 |
|---|---|---|
| Deep brain stimulationComparison ON vs OFF | Device | OFF, ON |
Primary outcome
Anal pressure
Time frame: 2 hours
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 7 Feb 2012.
- Derived from this study: PubMed 26053217Derrey S, Chastan N, Maltete D, Verin E, Dechelotte P, Lefaucheur R, Proust F, Freger P, Leroi AM, Weber J, Gourcerol G. Impact of deep brain stimulation on pharyngo-esophageal motility: a randomized cross-over study. Neurogastroenterol Motil. 2015 Sep;27(9):1214-22. doi: 10.1111/nmo.12607. Epub 2015 Jun 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with Parkinson's Disease, run by University Hospital, Rouen at 1 site in France.
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 6 inclusion and 10 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 7 Feb 2012. 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 France. 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. Some participants in this study may receive a placebo. 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?
Anal pressure (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01081457, which also lists 1 linked publication.
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 7 Feb 2012.