Electroencephalographic Monitoring in Patients Treated by Deep Brain Stimulation

Psychiatric Disorder Clinical Trial

— EEG-DBS  

Official title:

Monitoring électroencéphalographique Chez Les Patients traités Par Stimulation cérébrale Profonde

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03114748
• Other study ID #: 2012-A00490-43
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2012
• Est. completion date: September 2021

Study information

• Verified date: July 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2021
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Motor Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

Other:
• EEG

• DBS switched OFF and ON

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG recordings from 96 scalp electrodes	high resolution voltage signal from the patients scalp	around 15 minutes for each condition