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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01284686
Other study ID # 2009-A00913-54
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 26, 2012
Est. completion date May 27, 2015

Study information

Verified date July 2022
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date May 27, 2015
Est. primary completion date May 27, 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
France APHM Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary the understanding of the mechanisms underlying the propagation of pathological oscillatory activities in PD 24 months
Secondary may provide a basis for different therapeutic strategies 24 months
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