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Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility (SCP-Comodig)

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ClinicalTrials.gov Identifier: NCT01081457
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : February 7, 2012
Sponsor:
Information provided by (Responsible Party):
Guillaume GOURCEROL, University Hospital, Rouen

Study Description
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Brief 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. 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 or disease Intervention/treatment Phase
Parkinson's Disease Device: Deep brain stimulation Not Applicable

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Anal pressure [ Time Frame: 2 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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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


Locations
France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
More Information
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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
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 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