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State Dependent Resonance in the BG-cortical Loops

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00683566
First received: February 26, 2008
Last updated: January 29, 2010
Last verified: January 2010
History of Changes
  Purpose

Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is abnormally synchronized and rhythmic. The oscillatory activity prevails at 8-30 Hz in untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels inversely correlates with motor impairment. Moreover, these different levels in BG-cortical loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment following treatment with dopaminergic drugs and is partially suppressed prior to and during voluntary movements. An unanswered question is how do BG-cortical loops become so prominently engaged in this oscillatory activity? One possible explanation is that the resonance frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that oscillations in this band are transmitted particularly well. So we hypothesize loop resonances in the 8-30 Hz frequency band at rest, which should be suppressed during movement and following dopaminergic therapy.


Condition Intervention
Parkinson Disease
 Procedure: electrostimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: State Dependent Resonance in the BG-cortical Loops

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • The results are expected to bring further light into the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD and may provide a basis for different therapeutic strategies. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
A session in condition ON DOPAMINE and the other one in condition OFF DOPAMINE.
 Procedure: electrostimulation
Stimulate STN (at 0, 5, 10, 15, 20, 25, 30, 40, 70 and 130 Hz) in chronically implanted patients at rest and during simple and complex motor tasks

Detailed Description:

Stimulate STN (at 0, 5, 10, 15, 20, 25, 30, 40, 70 and 130 Hz) in chronically implanted patients at rest and during simple and complex motor tasks while recording the steady state evoked potential over the cortex using EEG over the 19 sites of the classical 10/20 system and a channel to record artifact over the stimulator. Experiments will be carried out both in the OFF medication and ON medication condition.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parkinson's disease idiopathic evolving for more than 5 years
  • Electrodes of stimulation implanted in 2 nuclei under - thalamic in the service of functional and stereotaxic neurosurgery of the CHU La timone for at least 6 months
  • Doped sensibility superior to 50 % (estimated by the section III of the score UPDRS)
  • Efficiency of the stimulation superior to 30 % (estimated by the section III of the score UPDRS)

Exclusion Criteria:

  • Patients not verifying the criteria of inclusion
  • Absence of data concerning the location of electrodes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683566

Contacts
Contact: jean-philippe AZULAY, MD 33-49-13-8579 jpazulay@ap-hm.fr

Locations
France
AP-HM Timone Recruiting
Marseille, Bouches Du Rhone, France, 13005
Contact: jean-philippe AZULAY, MD     33-49-13-8579     jpazulau@ap-hm.fr    
Principal Investigator: jean-philippe azulay, md            
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: jean philippe AZULAY, MD AP-HM
  More Information

No publications provided

Responsible Party: Azulay JeanPhilippe MD, AP-HM
ClinicalTrials.gov Identifier: NCT00683566     History of Changes
Other Study ID Numbers: 2007-A01178-45, 2007 36
Study First Received: February 26, 2008
Last Updated: January 29, 2010
Health Authority: France: Direction Générale de la Santé

Keywords provided by Assistance Publique Hopitaux De Marseille:
parkinson

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 May 23, 2013