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

Primary Purpose

Motor Disorders, Psychiatric Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EEG
DBS switched OFF and ON
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Motor Disorders focused on measuring deep brain stimulation, EEG

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    EEG

    DBS ON and OFF

    Arm Description

    2 scalp electroencephalographic (EEG) recording will be acquired in ON and OFF DBS conditions

    DBS is turned ON and OFF in the 2 EEG sections

    Outcomes

    Primary Outcome Measures

    EEG recordings from 96 scalp electrodes
    high resolution voltage signal from the patients scalp

    Secondary Outcome Measures

    Full Information

    First Posted
    February 8, 2017
    Last Updated
    October 10, 2018
    Sponsor
    University Hospital, Grenoble
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03114748
    Brief Title
    Electroencephalographic Monitoring in Patients Treated by Deep Brain Stimulation
    Acronym
    EEG-DBS
    Official Title
    Monitoring électroencéphalographique Chez Les Patients traités Par Stimulation cérébrale Profonde
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    March 2019 (Anticipated)
    Study Completion Date
    September 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Grenoble

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Motor Disorders, Psychiatric Disorder
    Keywords
    deep brain stimulation, EEG

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EEG
    Arm Type
    Experimental
    Arm Description
    2 scalp electroencephalographic (EEG) recording will be acquired in ON and OFF DBS conditions
    Arm Title
    DBS ON and OFF
    Arm Type
    Experimental
    Arm Description
    DBS is turned ON and OFF in the 2 EEG sections
    Intervention Type
    Other
    Intervention Name(s)
    EEG
    Intervention Type
    Other
    Intervention Name(s)
    DBS switched OFF and ON
    Primary Outcome Measure Information:
    Title
    EEG recordings from 96 scalp electrodes
    Description
    high resolution voltage signal from the patients scalp
    Time Frame
    around 15 minutes for each condition

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stephan CHABARDES
    Organizational Affiliation
    University Hospital, Grenoble
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Electroencephalographic Monitoring in Patients Treated by Deep Brain Stimulation

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