NCT Number: NCT01682668
Subthalamic Nucleus, Akinesia and Parkinson's Disease
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 .
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Groupe Hospitalier Pitie-Salpêtrière, Paris, PARIS, France
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Primary outcomes
-
Firing rate of the subthalamic neurons
Time frame: During surgery for bilateral STN stimulation
Changes in the neuronal activity of the STN before, during and after the execution of an arm movement
Secondary outcomes
-
Evoked related potentials of the STN
Time frame: 3-5 days after surgery for bilateral STN stimulation
Local-field potentials recordings with DBS electrodes when performing the execution of an arm movement or gait initiation
-
Biomechanical parameters of gait initiation
Time frame: 6 months
Gait initiation parameters by using a forceplate and EMG recordings
Other outcomes
-
BOLD signal during fMRI
Time frame: 1 month before surgery
Changes in the BOLD signal during fMRI with virtual imagery of movement
-
real-life assessment
Time frame: 1 month after surgery
recording using the percept device
Study contacts
Contact information is provided by the study sponsor or research team.
Carine Karachi, MD, PhD
CONTACT
Marie-Laure Welter, MD, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Other Gov
Registry information
Official study title
Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.
Acronym: GB-MOV
Important dates
- Study start
- 2013
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Sep 11, 2012
- Registry last updated
- Jul 7, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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