Subthalamic Nucleus, Akinesia and Parkinson's Disease

NCT ID: NCT01682668

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2025-08-31

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 .

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Frequency of subthalamic stimulation

Comparison between healthy controls and PD patients (non-operable patients or who will be operated or already operated)

Group Type: EXPERIMENTAL

Bilateral subthalamic stimulation

Intervention Type: PROCEDURE

Interventions

Bilateral subthalamic stimulation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

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

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Laure Welter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

GHPS, APHP, Paris, France

Locations

CIC-GHPS

Paris, , France

Site Status: RECRUITING

Groupe Hospitalier Pitie-Salpêtrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marie-Laure Welter, MD, PhD

Role: CONTACT

marielaure.welter@icm-institute.org

Carine Karachi, MD, PhD

Role: CONTACT

carine.karachi@gmail.com

Facility Contacts

Marie-Laure WELTER, PH

Role: primary

marielaure.welter@icm-institute.org

0142162461

Marie-Laure Welter, MD, PhD

Role: primary

marie-laure.welter@psl.aphp.fr

Other Identifiers

2012-A00225-38

Identifier Type: REGISTRY

Identifier Source: secondary_id

C11-40

Identifier Type: -

Identifier Source: org_study_id