NCT03114748

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

October 11, 2018

Status Verified

July 1, 2018

Enrollment Period

6.8 years

First QC Date

February 8, 2017

Last Update Submit

October 10, 2018

Conditions

Motor DisordersPsychiatric Disorder

Keywords

deep brain stimulationEEG

Outcome Measures

Primary Outcomes (1)

  • EEG recordings from 96 scalp electrodes

    high resolution voltage signal from the patients scalp

    around 15 minutes for each condition

Study Arms (2)

EEG

EXPERIMENTAL

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

Other: EEG

DBS ON and OFF

EXPERIMENTAL

DBS is turned ON and OFF in the 2 EEG sections

Other: DBS switched OFF and ON

Interventions

EEGOTHER
EEG
DBS switched OFF and ONOTHER
DBS ON and OFF

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patient treated with DBS
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor DisordersMental Disorders

Study Officials

  • Stephan CHABARDES

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2017

First Posted

April 14, 2017

Study Start

May 1, 2012

Primary Completion

March 1, 2019

Study Completion

September 1, 2021

Last Updated

October 11, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share