Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility (SCP-Comodig)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01081457 |
Recruitment Status :
Completed
First Posted : March 5, 2010
Last Update Posted : February 7, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease | Device: Deep brain stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Effect of Deep Brain Stimulation on Voluntary and Involuntary Gastrointestinal Motility in Parkinson's Disease |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | January 2012 |
Actual Study Completion Date : | January 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: ON
Stimulator switched ON
|
Device: Deep brain stimulation
Comparison ON vs OFF |
Sham Comparator: OFF
Stimulator switched OFF
|
Device: Deep brain stimulation
Comparison ON vs OFF |
- Anal pressure [ Time Frame: 2 hours ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- patient below 18 yo
- pregnancy
- Severe psychiatric or cognitive disorders
- diabetes mellitus
- morbid obesity
- compulsive eating disorders
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081457
France | |
Rouen University Hospital | |
Rouen, France, 76031 |
Responsible Party: | Guillaume GOURCEROL, MD, University Hospital, Rouen |
ClinicalTrials.gov Identifier: | NCT01081457 |
Other Study ID Numbers: |
2008/163/HP |
First Posted: | March 5, 2010 Key Record Dates |
Last Update Posted: | February 7, 2012 |
Last Verified: | February 2012 |
Parkinson's disease deep brain stimulation GI motility |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |