Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation

May 11, 2026 updated by: University Hospital, Bordeaux

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pessac, France, 33604
        • Service de neurologie Hôpital Haut-Lévêque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Deep Brain Stimulation of the Subthalamic Nucleus
Procedure: Deep brain stimulation
Brain Stimulation of the Subthalamic Nucleus
Active Comparator: 2
Later Deep Brain Stimulation of the Subthalamic Nucleus
Procedure: Deep brain stimulation
Brain Stimulation of the Subthalamic Nucleus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
After surgery and at 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight gain
Time Frame: At visit 1 and at 3 months
At visit 1 and at 3 months
increase of energy intake
Time Frame: At visit 1 and at 3 months
At visit 1 and at 3 months
leptin, glucose, insulin blood levels
Time Frame: At visite 1 and at 3 months
At visite 1 and at 3 months
cognitive and psychological assessments
Time Frame: before surgery and after 3 months
before surgery and after 3 months
UDPRS scale
Time Frame: before surgery and after 3 months
before surgery and after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: François TISON, Pr, Service de neurologie Hôpital Haut-Lévêque Pessac
  • Study Chair: Jacques DEMOTES-MAINARD, Pr, CIC Inserm-CHU de Bordeaux Pessac

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9212-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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