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

This study has been completed.
Information provided by (Responsible Party):
Guillaume GOURCEROL, University Hospital, Rouen Identifier:
First received: March 4, 2010
Last updated: February 6, 2012
Last verified: February 2012
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:

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01081457

Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Guillaume GOURCEROL, MD, University Hospital, Rouen 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 processed this record on September 19, 2017