Electrophysiology of Brain Activity During Electrode Implantation in Patients Treated With Deep Brain Stimulation

NCT03874611 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2019-03-14

No results posted yet for this study

Summary

Primary objective

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.

Research hypotheses

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-13
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03874611 on ClinicalTrials.gov