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
About this trial
This is an interventional basic science trial for Motor Disorders focused on measuring deep brain stimulation, EEG
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)
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
NCT ID
NCT03114748
First Posted
February 8, 2017
Last Updated
October 10, 2018
Sponsor
University Hospital, Grenoble
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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