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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
History of Changes
  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: 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:

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Anal pressure [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by 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 June 18, 2013