Text Size

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

This study is not yet open for participant recruitment.
Verified September 2012 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01682668
First received: July 19, 2012
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  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: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Gait initiation parameters by using a forceplate and EMG recordings


Other Outcome Measures:
  • BOLD signal during fMRI [ Time Frame: 1 month before surgery ] [ Designated as safety issue: No ]
    Changes in the BOLD signal during fMRI with virtual imagery of movement


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682668

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

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

No publications provided

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
Study First Received: July 19, 2012
Last Updated: September 7, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on June 17, 2013