Parkinson's DiseasePhase 2NCT00529724
Body Weight Gain, Parkinson, Subthalamic Stimulation
A Phase 2 study testing Energy metabolism by chronic bilateral subthalamic stimulation in people with Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in patients with motor complications. However, the post-operative body weight gain involved may limit the benefits of surgery and induce critical metabolic disorder. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Energy metabolism by chronic bilateral subthalamic stimulation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2007to 1 Jun 2018
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 70 years old
- Diagnosis of Parkinson' disease established for 5 years at least
- Ldopa effect > 50 %
- Hoehn and Yarh score > 2.5 in On phase
Who cannot join
- Metabolism disorder
- Biological analysis abnormal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanisms of Body Weight Gain in Patients With Parkinson's Disease After Subthalamic Stimulation
Chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in patients with motor complications. However, the post-operative body weight gain involved may limit the benefits of surgery and induce critical metabolic disorder. The aim of this study to determine the energy expenditure in usual conditions of life.
Read the detailed description
Patients will be studied before (between 3 and 1 months) and after (1 month) STN-DBS surgery. Each time the same measurements will be taken. The principal ones will be :
- Clinical examination
- Autoevaluation dietary questionnaire
- Biological tests
- Study in calorimetry chamber (only in Clermont-Ferrand centre)
- Heart rate recorded during 7 days in usual conditions of life
- Energy expenditure recorded during 14 days in usual conditions of life with normalized water (18O 10 %) and Deuterium oxide (99.94 %D)
- Acute Ldopa challenge (in both conditions of dopa and stim)
- Apathy evaluation
- Body weight, and body compositions measurements
- Conditions
- Parkinson's Disease
- Being tested
- Energy metabolism by chronic bilateral subthalamic stimulation
- Keywords
- Energy metabolism, metabolic syndrome, by chronic bilateral subthalamic stimulation, Parkinson's disease, Patients with Parkinson's disease and will be treated by chronic bilateral subthalamic stimulation.
- Medical subject headings
- Parkinson Disease, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy metabolism by chronic bilateral subthalamic stimulationBehavioural
Patients will be studied before and after STN-DBS surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate recorded during 7 days in usual conditions of life
Measured: 7 days in usual conditions of life
energy expenditure recorded during 14 days in usual conditions of life with normalized water (18O 10 %) and Deuterium oxide (99.94 %D)
Measured: 14 days in usual conditions of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study start3 Sep 2007
- Primary completion21 Sep 2015
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Franck Durif, Pr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529724
- Sponsor's protocol ID
- CHU-0024
- Status last verified
- May 2023
- First submitted
- 13 Sep 2007
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Body Weight Gain in Patients With Parkinson's Disease After Subthalamic Stimulation
- ClinicalTrials.gov ID
- NCT00529724
- Acronym / sponsor ID
- CHU-0024
- Conditions
- Parkinson's Disease
- Keywords
- Energy metabolism, metabolic syndrome, by chronic bilateral subthalamic stimulation, Parkinson's disease, Patients with Parkinson's disease and will be treated by chronic bilateral subthalamic stimulation.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 3 Sep 2007 (actual)
- Primary completion
- 21 Sep 2015 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 14 Sep 2007 (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.
Chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in patients with motor complications. However, the post-operative body weight gain involved may limit the benefits of surgery and induce critical metabolic disorder. The aim of this study to determine the energy expenditure in usual conditions of life.
Detailed description
Patients will be studied before (between 3 and 1 months) and after (1 month) STN-DBS surgery. Each time the same measurements will be taken. The principal ones will be :
- Clinical examination
- Autoevaluation dietary questionnaire
- Biological tests
- Study in calorimetry chamber (only in Clermont-Ferrand centre)
- Heart rate recorded during 7 days in usual conditions of life
- Energy expenditure recorded during 14 days in usual conditions of life with normalized water (18O 10 %) and Deuterium oxide (99.94 %D)
- Acute Ldopa challenge (in both conditions of dopa and stim)
- Apathy evaluation
- Body weight, and body compositions measurements
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 70 years old
- Diagnosis of Parkinson' disease established for 5 years at least
- Ldopa effect > 50 %
- Hoehn and Yarh score > 2.5 in On phase
Key exclusion criteria (2 listed)
- Metabolism disorder
- Biological analysis abnormal
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 |
|---|---|---|
| Energy metabolism by chronic bilateral subthalamic stimulationPatients will be studied before and after STN-DBS surgery | Behavioural | – |
Primary outcome
heart rate recorded during 7 days in usual conditions of life
Time frame: 7 days in usual conditions of life
energy expenditure recorded during 14 days in usual conditions of life with normalized water (18O 10 %) and Deuterium oxide (99.94 %D)
Time frame: 14 days in usual conditions of life
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 24 May 2023.
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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.
Franck Durif, Pr principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Energy metabolism by chronic bilateral subthalamic stimulation in people with Parkinson's Disease, run by University Hospital, Clermont-Ferrand 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 4 inclusion and 2 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 24 May 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
heart rate recorded during 7 days in usual conditions of life (time frame: 7 days in usual conditions of life). The study lists 2 primary outcomes in all. 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 24 May 2023.