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

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01682668
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arm: 1
• Duration (Months): 120
• Patients Per Site: 30
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Procedure: Bilateral subthalamic stimulation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.
• Study Start Date: Feb 1, 2013
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Frequency of subthalamic stimulation Comparison between healthy controls and PD patients	Procedure: Bilateral subthalamic stimulation

Outcome Measures

Primary Outcome Measures

1. Firing rate of the subthalamic neurons [During surgery for bilateral STN stimulation]

   Changes in the neuronal activity of the STN before, during and after the execution of an arm movement

Secondary Outcome Measures

1. Evoked related potentials of the STN [3-5 days after surgery for bilateral STN stimulation]

   Local-field potentials recordings with DBS electrodes when performing the execution of an arm movement or gait initiation

2. Biomechanical parameters of gait initiation [6 months]

   Gait initiation parameters by using a forceplate and EMG recordings

Other Outcome Measures

1. BOLD signal during fMRI [1 month before surgery]

   Changes in the BOLD signal during fMRI with virtual imagery of movement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients with Parkinson's disease candidate to DBS surgery

• Age: 18-70 years

• Normal brain MRI

• Signature of the informed written consent

• Healthy age-matched control subjects

Exclusion Criteria:

• contraindication to MRI

• contraindication to DBS surgery for PD patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CIC-GHPS	Paris		France	75013
2	Groupe Hospitalier Pitie-Salpêtrière	Paris		France	75013

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Marie-Laure Welter, MD, PhD, GHPS, APHP, Paris, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
• ClinicalTrials.gov Identifier: NCT01682668
• Other Study ID Numbers: C11-40; 2012-A00225-38
• First Posted: Sep 11, 2012
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France: parkinson's disease; subthalamic nucleus; akinesia; gait initiation; neuronal activity; before STN stimulation; with STN stimulation; functional MRI
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Jul 27, 2021