Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation

NCT ID: NCT00221793

Last Updated: 2008-09-18

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2006-12-31

Brief Summary

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The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and to study its link with an energetic balance change.

Detailed Description

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The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and to study its link with an energetic balance change.

Twenty parkinsonian patients will be randomised : the delay between inclusion and neurostimulation wil be lengthened 3 months for one group, compared to the second one. The energy expenditure, at rest and after ingestion of a test meal, will be compared between the group of patients that had been neurostimulated and the group whose intervention has been postponed. Weight changes, energy intake, leptin level, neurophysiological parameters will be compared between both groups, and the nature and repartition of the weight gain will be assessed in the neurostimulated group. An eventual link between motor factors, pharmacological factors, and gain weight will be studied.

Conditions

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Parkinson Disease

Keywords

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Parkinson deep subthalamic stimulation pharmacological treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Deep Brain Stimulation of the Subthalamic Nucleus

Group Type EXPERIMENTAL

Deep brain stimulation

Intervention Type PROCEDURE

Brain Stimulation of the Subthalamic Nucleus

2

Later Deep Brain Stimulation of the Subthalamic Nucleus

Group Type ACTIVE_COMPARATOR

Deep brain stimulation

Intervention Type PROCEDURE

Brain Stimulation of the Subthalamic Nucleus

Interventions

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Deep brain stimulation

Brain Stimulation of the Subthalamic Nucleus

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age between 35 and 70; male or female; parkinson disease, with levo dopa response (at least 30%); severe but stable incapacity; no dementia, no psychosis, no depression; normal brain scanner done during the last 2 years.

Exclusion Criteria

* diabetes thyroid disease pacemaker coagulation troubles previous drug abuse
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, Bordeaux

Principal Investigators

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François TISON, Pr

Role: PRINCIPAL_INVESTIGATOR

Service de neurologie Hôpital Haut-Lévêque Pessac

Jacques DEMOTES-MAINARD, Pr

Role: STUDY_CHAIR

CIC Inserm-CHU de Bordeaux Pessac

Locations

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Service de neurologie Hôpital Haut-Lévêque

Pessac, , France

Site Status

Countries

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France

Other Identifiers

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9212-02

Identifier Type: -

Identifier Source: org_study_id