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

This study has been completed.
Sponsor:
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

March 4, 2010
February 6, 2012
January 2010
January 2012   (final data collection date for primary outcome measure)
Anal pressure [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01081457 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Parkinson's Disease
Device: Deep brain stimulation
Comparison ON vs OFF
  • Active Comparator: ON
    Stimulator switched ON
    Intervention: Device: Deep brain stimulation
  • Sham Comparator: OFF
    Stimulator switched OFF
    Intervention: Device: Deep brain stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01081457
2008/163/HP
Yes
Guillaume GOURCEROL, University Hospital, Rouen
University Hospital, Rouen
Not Provided
Not Provided
University Hospital, Rouen
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP