Skip to content

Subthalamic Nucleus, Akinesia and Parkinson's Disease

Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01682668
Acronym
GB-MOV
Enrollment
180
Registered
2012-09-11
Start date
2013-02-01
Completion date
2026-08-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

parkinson's disease, subthalamic nucleus, akinesia, gait initiation, neuronal activity, before STN stimulation, with STN stimulation, functional MRI

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 .

Interventions

PROCEDUREBilateral subthalamic stimulation

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Firing rate of the subthalamic neuronsDuring surgery for bilateral STN stimulationChanges in the neuronal activity of the STN before, during and after the execution of an arm movement

Secondary

MeasureTime frameDescription
Evoked related potentials of the STN3-5 days after surgery for bilateral STN stimulationLocal-field potentials recordings with DBS electrodes when performing the execution of an arm movement or gait initiation
Biomechanical parameters of gait initiation6 monthsGait initiation parameters by using a forceplate and EMG recordings

Countries

France

Contacts

CONTACTMarie-Laure Welter, MD, PhD
marielaure.welter@icm-institute.org
CONTACTCarine Karachi, MD, PhD
carine.karachi@gmail.com
PRINCIPAL_INVESTIGATORMarie-Laure Welter, MD, PhD

GHPS, APHP, Paris, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026