Parkinson DiseaseIPOLAPNCT02704910
Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?
A study testing Subthalamic stimulation in people with Parkinson Disease, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
The objective of this study is to assess the origins of lateral postural inclination presented by some Parkinson disease's patients. Several mechanisms could cause lateral postural inclination. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Subthalamic stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2012to Jun 2015
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30 to 75 years old patient
- Parkinson disease's diagnosed since 5 years
- Treated by deep brain stimulation
- Patient with at least 6 degree lateral deviation
- Without vestibular troubles nor peripheral sensorial trouble.
Who cannot join
- Dementia (Mattis < 130 ou MMS <24), or severe depressive episode according to DSM IV-R criteria
- Camptocormia or incompatible anteflexion with the dispositive of measure device
- Pregnant woman, nursing mother
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Grenoble - Médecine Physique et de Réadapatation
Grenoble, 38043
CHU de Grenoble - Unité des troubles du mouvement
Grenoble, 38043
About this study
The objective of this study is to assess the origins of lateral postural inclination presented by some Parkinson disease's patients.
Several mechanisms could cause lateral postural inclination. Available data allow to suggest three hypothesis: (troubles of tonus, perception of vertical perturbation, trouble of perception of corporal axis
Read the detailed description
Inclusion Criteria:
- 30 to 75 years old patient
- Parkinson disease's diagnosed since 5 years
- Treated by deep brain stimulation
- Patient with at least 6 degree lateral deviation
- Without vestibular troubles nor peripheral sensorial trouble.
Exclusion Criteria:
- Dementia (Mattis < 130 ou MMS <24), or severe depressive episode according to DSM IV-R criteria
- Camptocormia or incompatible anteflexion with the dispositive of measure device
- Pregnant woman, nursing mother
- Conditions
- Parkinson Disease
- Being tested
- Subthalamic stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subthalamic stimulationBehavioural
Assess difference of amplitude (in degree) of the postural deviation between both condition of unilateral condition of subthalamic nucleus
| Study group | Role | What they receive |
|---|---|---|
| Voluntary subject | Placebo comparator | Patient without parkinson disease, without deep brain stimulation Receives: Behavioral: Subthalamic stimulation |
| Patients | Active comparator | Subthalamic stimulation Receives: Behavioral: Subthalamic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateropulsion measured by computerized Posturography
The postural inclination is measured in two conditions: With and without Deep Brain Stimulation. (Gissot et al., 2007).
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startJan 2012
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Not more patient with lateral deviation
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, GrenobleThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Krack, MD, Study director, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704910
- Sponsor's protocol ID
- 1131
- Other IDs
- ID RCB
- Acronym
- IPOLAP
- Status last verified
- Jun 2016
- First submitted
- 20 Feb 2012
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?
- ClinicalTrials.gov ID
- NCT02704910
- Acronym / sponsor ID
- IPOLAP / 1131
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not more patient with lateral deviation
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Mar 2016 (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 objective of this study is to assess the origins of lateral postural inclination presented by some Parkinson disease's patients.
Several mechanisms could cause lateral postural inclination. Available data allow to suggest three hypothesis: (troubles of tonus, perception of vertical perturbation, trouble of perception of corporal axis
Detailed description
Inclusion Criteria:
- 30 to 75 years old patient
- Parkinson disease's diagnosed since 5 years
- Treated by deep brain stimulation
- Patient with at least 6 degree lateral deviation
- Without vestibular troubles nor peripheral sensorial trouble.
Exclusion Criteria:
- Dementia (Mattis < 130 ou MMS <24), or severe depressive episode according to DSM IV-R criteria
- Camptocormia or incompatible anteflexion with the dispositive of measure device
- Pregnant woman, nursing mother
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voluntary subject | Placebo comparator | Behavioral: Subthalamic stimulationPatient without parkinson disease, without deep brain stimulation |
| Patients | Active comparator | Behavioral: Subthalamic stimulationSubthalamic stimulation |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 30 to 75 years old patient
- Parkinson disease's diagnosed since 5 years
- Treated by deep brain stimulation
- Patient with at least 6 degree lateral deviation
- Without vestibular troubles nor peripheral sensorial trouble.
Key exclusion criteria (3 listed)
- Dementia (Mattis < 130 ou MMS <24), or severe depressive episode according to DSM IV-R criteria
- Camptocormia or incompatible anteflexion with the dispositive of measure device
- Pregnant woman, nursing mother
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 |
|---|---|---|
| Subthalamic stimulationAssess difference of amplitude (in degree) of the postural deviation between both condition of unilateral condition of subthalamic nucleus | Behavioural | Patients, Voluntary subject |
Primary outcome
Lateropulsion measured by computerized Posturography
Time frame: 4 days
The postural inclination is measured in two conditions: With and without Deep Brain Stimulation. (Gissot et al., 2007).
Results and safety
The study was stopped early (reason given: Not more patient with lateral deviation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
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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.
Paul Krack, MD study director
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subthalamic stimulation in people with Parkinson Disease, run by University Hospital, Grenoble at 2 sites 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Not more patient with lateral deviation). Results are not available in the source record.
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?
Lateropulsion measured by computerized Posturography (time frame: 4 days). 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 22 Jun 2016.