Subthalamic Nucleus, Akinesia and Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bilateral subthalamic stimulation.
- Who it may be relevant to
- Registry conditions: Parkinson's Disease. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.
Overview
This program aims to understand the role of the subthalamic nucleus in the control of the movement in healthy humans and patients with Parkinson's disease, how the STN dysfunction contributes to akinesia and how the STN stimulation improves motor signs in PD patients .
Interventions
- Procedure Bilateral subthalamic stimulation
Primary outcome measures
- Firing rate of the subthalamic neurons [Time frame: During surgery for bilateral STN stimulation]
Secondary outcome measures (2)
- Evoked related potentials of the STN [Time frame: 3-5 days after surgery for bilateral STN stimulation]
- Biomechanical parameters of gait initiation [Time frame: 6 months]
Eligibility criteria
Inclusion criteria for patients who will be operated
- Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank)
- Age between 18 and 70;
- Motor complications in the form of fluctuations in motor state or dyskinesias induced by dopaminergic therapy, despite medical treatment optimum;
- Other medical conditions that are stable or do not interfere with the procedure proposed;
- Excellent responsiveness to levodopa (UPDRS motor score improvement greater than 50% in the acute levodopa test)
- Brain MRI without abnormality
- Normality of biological examinations
- Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
- Patient with social health insurance
Criteria for non-inclusion of Parkinsonian patients who will be operated
- Contraindication to examinations necessary for inclusion
- Evolutionary psychiatric pathology;
- Dementia(MMS<24/30);
- Patients with a medical condition that makes surgery dangerous neuro-surgical;
- Bleeding-promoting diseases and laboratory test abnormalities clotting;
- Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia).
- Taking drugs interfering with coagulation for 1 month before intervention.
- Persons under guardianship, curatorship or any other administrative or judicial measure deprivation of rights and liberty
Selection criteria for non-operated patients
- Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank);
- Age between 18 and 70;
- Other medical conditions that are stable or do not interfere with the proposed protocol;
- Presence of axial signs (gait and/or balance disorders) no improved by antiparkinsonian treatment
- Brain MRI without notable abnormality
- Normality of biological examinations
- Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
- Patient with social health insurance
Criteria for non-inclusion of non-operated patients
- Contraindication to examinations necessary for inclusion
- Progressive psychiatric pathology;
- Dementia (MMS<24/30);
- Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia).
- Persons under guardianship, curatorship or any other administrative or judicial measuredeprivation of rights and liberty
Inclusion criteria for group 3 patients (already operated)
- Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank);
- Bilateral deep brain stimulation of the subthalamic nucleus for more than 1 year
- Age between 18 and 70;
- Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
- Patient with social health insurance
Criteria for non-inclusion of Parkinsonian patients (already operated)
- Contraindication to examinations necessary for inclusion
- Evolutionary psychiatric pathology;
- Dementia(MMS<24/30);
- Persons under guardianship, curatorship or any other administrative or judicial measure deprivation of rights and liberty
Inclusion criteria for healthy subjects
- Age between 18 and 70 years old
- Normal neurological examination
- Person who voluntarily and informedly agreed to participate in the study (signature of a written consent)
- Patient with social health insurance
Criteria for non-inclusion of healthy subjects
- Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and freedom
- Existence of neurological, orthopedic or psychiatric history
- Existence of contraindications to MRI (cardiac or neural pacemaker, ferromagnetic surgical clips, implants and metallic objects, foreign bodies intraocular, pregnancy, claustrophobia).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 2 centers
- Groupe Hospitalier Pitie-Salpêtrière — Paris
- CIC-GHPS — Paris
Identifiers
NCT: NCT01682668 · C11-40 · 2012-A00225-38