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

This study is currently recruiting participants.
Verified February 2016 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
ClinicalTrials.gov Identifier:
NCT01682668
First Posted: September 11, 2012
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
  Purpose
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 Intervention
Parkinson's Disease Procedure: Bilateral subthalamic stimulation

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Firing rate of the subthalamic neurons [ Time Frame: 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:
  • Evoked related potentials of the STN [ Time Frame: 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

  • Biomechanical parameters of gait initiation [ Time Frame: 6 months ]
    Gait initiation parameters by using a forceplate and EMG recordings


Other Outcome Measures:
  • BOLD signal during fMRI [ Time Frame: 1 month before surgery ]
    Changes in the BOLD signal during fMRI with virtual imagery of movement


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Frequency of subthalamic stimulation
Comparison between healthy controls and PD patients
Procedure: Bilateral subthalamic stimulation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682668


Contacts
Contact: Marie-Laure Welter, MD, PhD marie-laure.welter@psl.aphp.fr
Contact: Carine Karachi, MD, PhD carine.karachi@gmail.com

Locations
France
CIC-GHPS Recruiting
Paris, France, 75013
Contact: Marie-Laure WELTER, PH    0142162461    marie_laure.welter@psl.aphp.fr   
Groupe Hospitalier Pitie-Salpêtrière Recruiting
Paris, France, 75013
Contact: Marie-Laure Welter, MD, PhD       marie-laure.welter@psl.aphp.fr   
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
  More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01682668     History of Changes
Other Study ID Numbers: C11-40
2012-A00225-38 ( Registry Identifier: IDRCB )
First Submitted: July 19, 2012
First Posted: September 11, 2012
Last Update Posted: February 27, 2017
Last Verified: February 2016

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
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases