Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep brain stimulation

Device

Comparison ON vs OFF

Primary outcomes

Anal pressure

Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Effect of Deep Brain Stimulation on Voluntary and Involuntary Gastrointestinal Motility in Parkinson's Disease

Acronym: SCP-Comodig

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Mar 5, 2010
Registry last updated: Feb 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed