Text Size

Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops in Parkinson's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01284686
First received: January 26, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is abnormally synchronised 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. This hypothesis was confirmed in a previous series of experiments.The aim is to determine whether the resonance frequency within BG-cortical loops is correlated to the BG-cortical coherence frequency (with 20 subjets during 24 months).


Condition Intervention
Parkinson's Disease
Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops
 Other: subthalamo-cortical loops stimulation in a one-sided and bipolar way

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Pathophysiology of Neuronal Oscillations Within Subthalamo-cortical Loops in Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • may provide a basis for different therapeutic strategies [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dopamine
ON DOPA:The patient will take his usual treatment with dopamine
 Other: subthalamo-cortical loops stimulation in a one-sided and bipolar way
Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients
Experimental: without dopa
OFF Dopa: The patient will be deprived of his treatment usual dopaminergique for at least 12 hours
 Other: subthalamo-cortical loops stimulation in a one-sided and bipolar way
Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients

Detailed Description:

Methods: Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients at rest and during simple and complex motor tasks while recording the steady state evoked potential over the cortex using EEG. The resonance frequency will be calculated as previously (Eusebio et al, Brain 2009). Experiments will be carried out both in the OFF medication and ON medication condition.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parkinson's disease idiopathique evolving for more than 5 years
  • Dopa-Sensibility superior to 50 %
  • Electrodes of stimulation implanted in 2 NST at Timone (Pr PERAGUT)

Exclusion Criteria:

  • Bad tolerance of the condition OFF Dopa and\or OFF stimulation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284686

Contacts
Contact: Jean-Philippe AZULAY, professor +3349186588 jean-philippe.AZULAY@ap-hm.fr

Locations
France
APHM Recruiting
Marseille, France, 13
Contact: Jean-Philippe AZULAY, Professor         jean-philippe.AZULAY@ap-hm.fr    
Principal Investigator: Jean-Philippe AZULAY            
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Jean-Philippe AZULAY APHM
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille, Direction de la recherche
ClinicalTrials.gov Identifier: NCT01284686     History of Changes
Other Study ID Numbers: 2009-A00913-54
Study First Received: January 26, 2011
Last Updated: January 26, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
Pathophysiology
Parkinson
neuronal oscillations

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 19, 2013