Electrophysiology of Brain Activity During Electrode Implantation in Patients Treated With Deep Brain Stimulation (LFP-DBS)
|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.|
|ClinicalTrials.gov Identifier: NCT03874611|
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Demonstrate functional markers derived from electrophysiological signals recorded during cognitive tests. These markers should make it possible to optimize the targeting procedures of electrode implantation sites for a better effectiveness of deep brain stimulation therapy.
The mechanisms of action of the deep brain stimulation (DBS) involve the modulation of the activity, locally and on a large scale, of functional cortical-subcortical networks showing pathological behavior beforehand. The electrophysiological measurements in response to different tasks make it possible to highlight precise dysfunctions of these neural networks, in relation with the behavioral and / or motor disorders associated with the pathologies treated by DBS.
Consequently, we hypothesize that the exploitation of electrophysiological responses during cognitive or sensorimotor tasks performed during the implantation procedure of stimulation electrodes in patients treated with DBS will allow :
- To collect fundamental data to understanding the physiological functioning of basal ganglia in humans ;
- To collect functional markers from the operating room in relation to the symptoms targeted by the DBS that will help in the choice of implantation site of the stimulation electrode ;
- Define long-term predictive markers of DBS effects by comparing electrophysiological effects measured post-operatively and clinical scores under DBS.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Obsessive-Compulsive Disorder Epilepsy Depression||Other: electrophysiological data from DBS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Electrophysiology of Brain Activity During Electrode Implantation in Patients Treated With Deep Brain Stimulation|
|Actual Study Start Date :||April 13, 2011|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
|Experimental: electrophysiological data from DBS||
Other: electrophysiological data from DBS
For each selected patient, the evaluation of cognitive or sensory-motor functions by electrophysiology will be conducted in the operating room, preoperatively the week before implantation and post-operatively within five days between the implantation of deep electrodes and the setting of the stimulator.
- Number of functional markers derived from electrophysiological signals recorded during cognitive tests. [ Time Frame: 5 days ]The latency of task-related electrophysiological responses derived from deep brain electrodes, as assessed by time-frequency and evoked-responses analyses.
- Number of functional markers derived from electrophysiological signals recorded during cognitive tests. [ Time Frame: 5 days ]The amplitude of task-related electrophysiological responses derived from deep brain electrodes, as assessed by time-frequency and evoked-responses analyses.
- cognitive and sensorimotor tasks [ Time Frame: 5 days ]percentage of electrode contacts within a given brain area that will display task-evoked neural responses (as assessed by time-frequency analyses) for a given task.
- functional atlas of basal ganglia [ Time Frame: 5 days ]statistical effects of each task as assessed by t-tests performed across patient's task-related electrophysiological responses (as assessed by time-frequency analyses).
- number of electrophysiological responses [ Time Frame: 5 days ]time and frequency analyses
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874611
|Contact: Olivier David, Dr||04 56 52 05 86||Olivier.David@inserm.fr|
|Contact: Julien Bastin, Dr||04 56 52 06 78||Julien.Bastin@univ-grenoble-alpes.fr|
|Contact: Stephan CHABARDES, Pr 04 76 76 75 59|
|Contact: Julien Bastin, Dr 04 56 52 06 78 Julien.Bastin@univ-grenoble-alpes.fr|