Parkinson DiseaseNCT00221793
Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation
A study testing Deep brain stimulation in people with Parkinson Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and to study its link with an energetic balance change. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2002to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- diabetes thyroid disease pacemaker coagulation troubles previous drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Deep brain stimulation
- Keywords
- Parkinson, deep subthalamic stimulation, pharmacological treatment
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationProcedure or surgery
Brain Stimulation of the Subthalamic Nucleus
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Deep Brain Stimulation of the Subthalamic Nucleus Receives: Procedure: Deep brain stimulation |
| 2 | Active comparator | Later Deep Brain Stimulation of the Subthalamic Nucleus Receives: Procedure: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After surgery and at 3 months
Secondary outcomes (5)
Weight gain
Measured: At visit 1 and at 3 months
increase of energy intake
Measured: At visit 1 and at 3 months
leptin, glucose, insulin blood levels
Measured: At visite 1 and at 3 months
cognitive and psychological assessments
Measured: before surgery and after 3 months
UDPRS scale
Measured: before surgery and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2002
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François TISON, Pr, Principal investigator, Service de neurologie Hôpital Haut-Lévêque PessacJacques DEMOTES-MAINARD, Pr, Study chair, CIC Inserm-CHU de Bordeaux Pessac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221793
- Sponsor's protocol ID
- 9212-02
- Status last verified
- Sep 2008
- First submitted
- 13 Sep 2005
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus
- ClinicalTrials.gov ID
- NCT00221793
- Acronym / sponsor ID
- 9212-02
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, deep subthalamic stimulation, pharmacological treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Deep brain stimulationDeep Brain Stimulation of the Subthalamic Nucleus |
| 2 | Active comparator | Procedure: Deep brain stimulationLater Deep Brain Stimulation of the Subthalamic Nucleus |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- diabetes thyroid disease pacemaker coagulation troubles previous drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep brain stimulationBrain Stimulation of the Subthalamic Nucleus | Procedure or surgery | 1, 2 |
Primary outcome
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
5 secondary outcomes
Weight gain
Time frame: At visit 1 and at 3 months
increase of energy intake
Time frame: At visit 1 and at 3 months
leptin, glucose, insulin blood levels
Time frame: At visite 1 and at 3 months
cognitive and psychological assessments
Time frame: before surgery and after 3 months
UDPRS scale
Time frame: before surgery and after 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François TISON, Pr principal investigator
Service de neurologie Hôpital Haut-Lévêque Pessac
Jacques DEMOTES-MAINARD, Pr study chair
CIC Inserm-CHU de Bordeaux Pessac
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with Parkinson Disease, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.