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

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ClinicalTrials.gov Identifier: NCT03114748
Recruitment Status : Active, not recruiting
First Posted : April 14, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Motor Disorders Psychiatric Disorder Other: EEG Other: DBS switched OFF and ON Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Monitoring électroencéphalographique Chez Les Patients traités Par Stimulation cérébrale Profonde
Study Start Date : May 2012
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2021

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



Primary Outcome Measures :
  1. EEG recordings from 96 scalp electrodes [ Time Frame: around 15 minutes for each condition ]
    high resolution voltage signal from the patients scalp



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114748


Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Stephan CHABARDES University Hospital, Grenoble
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03114748    
Other Study ID Numbers: 2012-A00490-43
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Grenoble:
deep brain stimulation
EEG
Additional relevant MeSH terms:
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Disease
Mental Disorders
Problem Behavior
Motor Disorders
Pathologic Processes
Behavioral Symptoms