Understanding the role of the subthalamic nucleus in Parkinson's disease

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

This study is testing how a part of the brain called the subthalamic nucleus affects movement in people with Parkinson's disease and whether stimulating it can help improve their motor symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (other gov)
• Locations: 2 sites (Paris and 1 other locations)
• Trial ID: NCT01682668 on ClinicalTrials.gov

What this trial studies

This program investigates how the subthalamic nucleus (STN) influences movement control in both healthy individuals and those with Parkinson's disease. It aims to explore the dysfunction of the STN and its contribution to akinesia, a common symptom in Parkinson's patients. The study will also assess how stimulation of the STN can improve motor symptoms associated with the disease. Participants will undergo bilateral subthalamic stimulation to evaluate its effects on their motor functions.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 to 70 diagnosed with idiopathic Parkinson's disease who experience motor complications despite optimal medical treatment.

Not a fit: Patients with contraindications to necessary examinations, significant psychiatric disorders, or dementia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for managing motor symptoms in Parkinson's disease patients.

How similar studies have performed: Previous studies have shown promising results with subthalamic nucleus stimulation in improving motor symptoms in Parkinson's disease, indicating a potential for success in this approach.

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).

Where this trial is running

Paris and 1 other locations

• CIC-GHPS — Paris, France (RECRUITING)
• Groupe Hospitalier Pitie-Salpêtrière — Paris, France (RECRUITING)

Study contacts

• Principal investigator: Marie-Laure Welter, MD, PhD — GHPS, APHP, Paris, France
• Study coordinator: Marie-Laure Welter, MD, PhD

Conditions: Parkinson's Disease, parkinson's disease, subthalamic nucleus, akinesia, gait initiation, neuronal activity, before STN stimulation, with STN stimulation