Subthalamic Nucleus, Akinesia and Parkinson's Disease

Parkinson's Disease Clinical Trial

— GB-MOV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01682668
• Other study ID #: C11-40
• Secondary ID: 2012-A00225-38
• Status: Recruiting
• Phase: N/A
• Start date: February 2013
• Est. completion date: August 2024

Study information

• Verified date: January 2023
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Marie-Laure Welter, MD, PhD
• Email: marielaure.welter[@]icm-institute.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Procedure:
• Bilateral subthalamic stimulation

Locations

Country	Name	City	State
France	CIC-GHPS	Paris
France	Groupe Hospitalier Pitie-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BOLD signal during fMRI	Changes in the BOLD signal during fMRI with virtual imagery of movement	1 month before surgery
Other	real-life assessment	recording using the percept device	1 month after surgery
Primary	Firing rate of the subthalamic neurons	Changes in the neuronal activity of the STN before, during and after the execution of an arm movement	During surgery for bilateral STN stimulation
Secondary	Evoked related potentials of the STN	Local-field potentials recordings with DBS electrodes when performing the execution of an arm movement or gait initiation	3-5 days after surgery for bilateral STN stimulation
Secondary	Biomechanical parameters of gait initiation	Gait initiation parameters by using a forceplate and EMG recordings	6 months