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Completed

NCT Number: NCT00221793

Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation

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

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Key information

Conditions

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

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de neurologie Hôpital Haut-Lévêque

Pessac, 33604, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Deep Brain Stimulation

Procedure

Brain Stimulation of the Subthalamic Nucleus

Primary outcomes

  1. Measurement of energy expenditure with indirect calorimetry in open chamber: at rest in the morning, without 24h-dopaminergic treatment, and after dopaminergic treatment intake; and post prandial thermogenesis after a test meal.

    Time frame: After surgery and at 3 months

Secondary outcomes

  1. Weight gain

    Time frame: At visit 1 and at 3 months

  2. increase of energy intake

    Time frame: At visit 1 and at 3 months

  3. leptin, glucose, insulin blood levels

    Time frame: At visite 1 and at 3 months

  4. cognitive and psychological assessments

    Time frame: before surgery and after 3 months

  5. UDPRS scale

    Time frame: before surgery and after 3 months

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
May 14, 2026

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.

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