Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility

Parkinson's Disease Clinical Trial

— SCP-Comodig  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081457
• Other study ID #: 2008/163/HP
• Status: Completed
• Phase: N/A
• First received: March 4, 2010
• Last updated: February 6, 2012
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Deep brain stimulation
Comparison ON vs OFF

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anal pressure		2 hours	No