Subthalamic Nucleus, Akinesia and Parkinson's Disease (GB-MOV)

Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in 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 .

Study Overview

• Status: Recruiting
• Conditions: Parkinson's Disease
• Intervention / Treatment: Procedure: Bilateral subthalamic stimulation

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Laure Welter, MD, PhD; Email: marielaure.welter@icm-institute.org
• Study Contact Backup: Name: Carine Karachi, MD, PhD; Email: carine.karachi@gmail.com

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Groupe Hospitalier Pitie-Salpetriere
    • Contact: Marie-Laure Welter, MD, PhD; Email: marie-laure.welter@psl.aphp.fr
  • Paris, France, 75013
    • Recruiting
    • CIC-GHPS
    • Contact: Marie-Laure WELTER, PH; Phone Number: 0142162461; Email: marielaure.welter@icm-institute.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Frequency of subthalamic stimulation; Comparison between healthy controls and PD patients (non-operable patients or who will be operated or already operated)	Procedure: Bilateral subthalamic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Biomechanical parameters of gait initiation	Gait initiation parameters by using a forceplate and EMG recordings	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BOLD signal during fMRI	Changes in the BOLD signal during fMRI with virtual imagery of movement	1 month before surgery
real-life assessment	recording using the percept device	1 month after surgery

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Marie-Laure Welter, MD, PhD, GHPS, APHP, Paris, France

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: September 7, 2012
• First Posted (Estimated): September 11, 2012

Study Record Updates

• Last Update Posted (Actual): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: functional MRI; subthalamic nucleus; gait initiation; parkinson's disease; akinesia; neuronal activity; before STN stimulation; with STN stimulation
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: C11-40; 2012-A00225-38 (Registry Identifier: IDRCB)