Clinical trial NCT01682668: Subthalamic Nucleus, Akinesia and Parkinson's Disease
Official title: Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Keywords: parkinson's disease
subthalamic nucleus
akinesia
gait initiation
neuronal activity
before STN stimulation
with STN stimulation
functional MRI
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2012-09-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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 .


Eligibility criteria: Inclusion criteria for patients who will be operated

1. Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank)
2. Age between 18 and 70;
3. Motor complications in the form of fluctuations in motor state or dyskinesias induced by dopaminergic therapy, despite medical treatment optimum;
4. Other medical conditions that are stable or do not interfere with the procedure proposed;
5. Excellent responsiveness to levodopa (UPDRS motor score improvement greater than 50% in the acute levodopa test)
6. Brain MRI without abnormality
7. Normality of biological examinations
8. Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
9. Patient with social health insurance

Criteria for non-inclusion of Parkinsonian patients who will be operated

1. Contraindication to examinations necessary for inclusion
2. Evolutionary psychiatric pathology;
3. Dementia(MMS\<24/30);
4. Patients with a medical condition that makes surgery dangerous neuro-surgical;
5. Bleeding-promoting diseases and laboratory test abnormalities clotting;
6. Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia).
7. Taking drugs interfering with coagulation for 1 month before intervention.
8. Persons under guardianship, curatorship or any other administrative or judicial measure deprivation of rights and liberty

Selection criteria for non-operated patients

1. Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank);
2. Age between 18 and 70;
3. Other medical conditions that are stable or do not interfere with the proposed protocol;
4. Presence of axial signs (gait and/or balance disorders) no improved by antiparkinsonian treatment
5. Brain MRI without notable abnormality
6. Normality of biological examinations
7. Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
8. Patient with social health insurance

Criteria for non-inclusion of non-operated patients

1. Contraindication to examinations necessary for inclusion
2. Progressive psychiatric pathology;
3. Dementia (MMS\<24/30);
4. Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia).
5. Persons under guardianship, curatorship or any other administrative or judicial measuredeprivation of rights and liberty

Inclusion criteria for group 3 patients (already operated)

1. Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank);
2. Bilateral deep brain stimulation of the subthalamic nucleus for more than 1 year
3. Age between 18 and 70;
4. Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent)
5. Patient with social health insurance

Criteria for non-inclusion of Parkinsonian patients (already operated)

1. Contraindication to examinations necessary for inclusion
2. Evolutionary psychiatric pathology;
3. Dementia(MMS\<24/30);
4. Persons under guardianship, curatorship or any other administrative or judicial measure deprivation of rights and liberty

Inclusion criteria for healthy subjects

1. Age between 18 and 70 years old
2. Normal neurological examination
3. Person who voluntarily and informedly agreed to participate in the study (signature of a written consent)
4. Patient with social health insurance

Criteria for non-inclusion of healthy subjects

1. Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and freedom
2. Existence of neurological, orthopedic or psychiatric history
3. Existence of contraindications to MRI (cardiac or neural pacemaker, ferromagnetic surgical clips, implants and metallic objects, foreign bodies intraocular, pregnancy, claustrophobia).

Primary outcomes:
measure: Firing rate of the subthalamic neurons
timeFrame: During surgery for bilateral STN stimulation
Secondary outcomes:
measure: Evoked related potentials of the STN
timeFrame: 3-5 days after surgery for bilateral STN stimulation
measure: Biomechanical parameters of gait initiation
timeFrame: 6 months
Other outcomes:
measure: BOLD signal during fMRI
timeFrame: 1 month before surgery
measure: real-life assessment
timeFrame: 1 month after surgery
Locations:
city: Paris
country: France
facility: CIC-GHPS
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpêtrière
Study officials:
affiliation: GHPS, APHP, Paris, France
name: Marie-Laure Welter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: