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Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation

U

University Hospital of Bordeaux

Status

Completed

Conditions

Parkinson Disease

Treatments

Procedure: Deep brain stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT00221793
9212-02

Details and patient eligibility

About

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

Full description

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.

Enrollment

20 patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

1
Experimental group
Description:
Deep Brain Stimulation of the Subthalamic Nucleus
Treatment:
Procedure: Deep brain stimulation
2
Active Comparator group
Description:
Later Deep Brain Stimulation of the Subthalamic Nucleus
Treatment:
Procedure: Deep brain stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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