Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility

NCT ID: NCT01081457

Last Updated: 2012-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ON

Stimulator switched ON

Group Type ACTIVE_COMPARATOR

Deep brain stimulation

Intervention Type DEVICE

Comparison ON vs OFF

OFF

Stimulator switched OFF

Group Type SHAM_COMPARATOR

Deep brain stimulation

Intervention Type DEVICE

Comparison ON vs OFF

Interventions

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Deep brain stimulation

Comparison ON vs OFF

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Guillaume GOURCEROL

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rouen University Hospital

Rouen, , France

Site Status

Countries

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France

References

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Derrey S, Chastan N, Maltete D, Verin E, Dechelotte P, Lefaucheur R, Proust F, Freger P, Leroi AM, Weber J, Gourcerol G. Impact of deep brain stimulation on pharyngo-esophageal motility: a randomized cross-over study. Neurogastroenterol Motil. 2015 Sep;27(9):1214-22. doi: 10.1111/nmo.12607. Epub 2015 Jun 5.

Reference Type DERIVED
PMID: 26053217 (View on PubMed)

Other Identifiers

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2008/163/HP

Identifier Type: -

Identifier Source: org_study_id

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