Electroencephalographic Monitoring in Patients Treated by Deep Brain Stimulation (EEG-DBS)

October 10, 2018 updated by: University Hospital, Grenoble

Monitoring électroencéphalographique Chez Les Patients traités Par Stimulation cérébrale Profonde

This protocol aims to develop the use of behavioral and electroencephalographic measures during cognitive tasks in patients treated with deep brain stimulation during the stimulation parameters adjustments. The main clinical goal of this protocol is to find behavioral and or electroencephalographic markers to evaluates the right targeting of stimulation electrodes. On the more fundamental point of view, the study of those data can be used to understand better the action mechanisms of deep brain stimulation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This protocol aims to understand how brain regions are modulated by deep brain stimulation using scalp electroencephalographic recordings. This protocol covers many pathologies which are thought to relate to different brain networks impairements and are therefore complementary in the understanding of cortical activation and modulation of this activation by deep brain stimulation. These diseases are motor (parkinson..) and psychiatric (obsessive compulsive disorders, treatment resistant depression..). To activate brain networks of interest, either implicating brain regions dysfunctional in the diseases or brain regions stimulated by the electrode, the investigators can use cognitive task which are know to involve those networks, for instance motor task for motor diseases as clicking with a computer mouse when presented with a specific type of stimulus on the screen. EEG recordings can then be processed to retrieve cortical activation and modulation of this activation with stimulation (using an ON DBS OFF DBS procedure) during task processing. These data are also very precious to study brain dynamic networks and their modulation by DBS. After analysis of these results, this protocol aims to be used in order to refine targeting, for instance when correlating cortical modulation with DBS and clinical improvement with electrode positions.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient treated with DBS
  • study inclusion written agreement by the patient or his legal representant
  • intellectual capacities compatible with cognitive task and EEG recordings
  • French native speaker and capacity to understand the study processes and particularly to fill in the auto questionaires
  • patients abled to give an enlighted agreement
  • patients who have an health insurance coverage

Exclusion Criteria:

  • people who fill in the articles L1121-5 to L1121-8 or the Public Health Code
  • patients who don't stand the transient interruption of stimulation
  • severe concomitant disease
  • disease which impose a treatment which modulates vigilance
  • cognitive alteration (Mattis<130)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EEG
2 scalp electroencephalographic (EEG) recording will be acquired in ON and OFF DBS conditions
Other: EEG
Experimental: DBS ON and OFF
DBS is turned ON and OFF in the 2 EEG sections
Other: DBS switched OFF and ON

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG recordings from 96 scalp electrodes
Time Frame: around 15 minutes for each condition
high resolution voltage signal from the patients scalp
around 15 minutes for each condition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Stephan CHABARDES, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A00490-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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