Motor DisordersEEG-DBSNCT03114748
Electroencephalographic Monitoring in Patients Treated by Deep Brain Stimulation
A study testing EEG and DBS switched OFF and ON in people with Motor Disorders and Psychiatric Disorder, run by University Hospital, Grenoble.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Motor Disorders, Psychiatric Disorder
- What is being tested?
- EEG and DBS switched OFF and ON
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Monitoring électroencéphalographique Chez Les Patients traités Par Stimulation cérébrale Profonde
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.
Read the 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.
- Conditions
- Motor Disorders, Psychiatric Disorder
- Being tested
- EEG, DBS switched OFF and ON
- Keywords
- deep brain stimulation, EEG
- Medical subject headings
- Motor Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGOther
DBS switched OFF and ONOther
| Study group | Role | What they receive |
|---|---|---|
| EEG | Experimental | 2 scalp electroencephalographic (EEG) recording will be acquired in ON and OFF DBS conditions Receives: Other: EEG |
| DBS ON and OFF | Experimental | DBS is turned ON and OFF in the 2 EEG sections Receives: Other: DBS switched OFF and ON |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG recordings from 96 scalp electrodes
high resolution voltage signal from the patients scalp
Measured: around 15 minutes for each condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startMay 2012
- Primary completionMar 2019 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan CHABARDES, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114748
- Sponsor's protocol ID
- 2012-A00490-43
- Acronym
- EEG-DBS
- Status last verified
- Jul 2018
- First submitted
- 8 Feb 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring électroencéphalographique Chez Les Patients traités Par Stimulation cérébrale Profonde
- ClinicalTrials.gov ID
- NCT03114748
- Acronym / sponsor ID
- EEG-DBS / 2012-A00490-43
- Conditions
- Motor Disorders, Psychiatric Disorder
- Keywords
- deep brain stimulation, EEG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEG | Experimental | Other: EEG2 scalp electroencephalographic (EEG) recording will be acquired in ON and OFF DBS conditions |
| DBS ON and OFF | Experimental | Other: DBS switched OFF and ONDBS is turned ON and OFF in the 2 EEG sections |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG | Other | EEG |
| DBS switched OFF and ON | Other | DBS ON and OFF |
Primary outcome
EEG recordings from 96 scalp electrodes
Time frame: around 15 minutes for each condition
high resolution voltage signal from the patients scalp
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan CHABARDES principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
A study testing EEG and DBS switched OFF and ON in people with Motor Disorders and Psychiatric Disorder, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG recordings from 96 scalp electrodes (time frame: around 15 minutes for each condition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.