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Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility (SCP-Comodig)
This study has been completed.
Sponsor:
University Hospital, Rouen
Information provided by (Responsible Party):
Guillaume GOURCEROL, University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01081457
First received: March 4, 2010
Last updated: February 6, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
| Parkinson's Disease | Device: Deep brain stimulation |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
U.S. FDA Resources
Further study details as provided by Guillaume GOURCEROL, University Hospital, Rouen:
Primary Outcome Measures:
- Anal pressure [ Time Frame: 2 hours ]
| Enrollment: | 16 |
| Study Start Date: | January 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081457
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081457
Locations
| France | |
| Rouen University Hospital | |
| Rouen, France, 76031 | |
Sponsors and Collaborators
University Hospital, Rouen
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Guillaume GOURCEROL, MD, University Hospital, Rouen |
| ClinicalTrials.gov Identifier: | NCT01081457 History of Changes |
| Other Study ID Numbers: |
2008/163/HP |
| Study First Received: | March 4, 2010 |
| Last Updated: | February 6, 2012 |
Keywords provided by Guillaume GOURCEROL, University Hospital, Rouen:
|
Parkinson's disease deep brain stimulation GI motility |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on September 19, 2017